Lab Medical International Vol.28.6-7

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ISSN 1068-1760 Vol. 28 No. 4 6-7/ 2011
DAILY CLINICAL LAB NEWS
Influenza Detection Assay Undergoing Clinical Trials
Tuberculosis Blood Test Recommended for Key Groups

blood test for latent tuberculosis infection (LTBI) should be the primary test in certain suspect groups suggests a recent official recommendation. The innovative blood test, called the interferon-gamma release assay (IGRAs), is now thought to be more reliable than the Mantoux Tuber-
Rapid Diagnostic Test for Blood Cancer

test combines several DNA technologies into a single diagnostic chip, which determines a patients risk profile for acute myeloid leukemia (AML). The assay uses the patients bone marrow collected in anticoagulant tubes and reveals that the prognosis for AML can be established to a
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fully automated molecular assay for detecting the Influenza viruses A and B is undergoing clinical trials in the US. The instrument platform combines fully automated sample extraction with real-time polymerase chain reaction (PCR) amplification and detection system that
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culin Sensitivity technique especially where the individual has already been vaccinated or was skin test positive. In recognition of the mounting clinical evidence in favor of IGRA technology, the UK National Institute for Health and Clinical Excellence (NICE; London, UK;
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New Immunoassay Diagnoses Spinal Muscular Atrophy
Blood Proteins Predict Ectopic Pregnancy
S
Image: Courtesy of HistoRx / Genoptix
pinal muscular atrophy (SMA), an autosomal recessive disorder and the leading genetic cause of infant mortality, is brought about by reduced levels of survival motor neuron (SMN) protein. An immunoassay system is now available for the identification and detection of that protein.
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regnant women have proteins in their blood that could be used for early diagnosis of ectopic pregnancy (EP). Scientists analyzed the proteins in blood from women with ectopic pregnancies and compared them to those in the blood of women with normal pregnancies. They
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INSIDE
Image: Colored scanning electron micrograph (SEM) of two nerve cells (red) in the grey matter of the spinal cord
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Advanced Prenatal Diagnostic System Based on Microarray Technology
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icroarray technology has been applied to the diagnosis of genetic syndromes during development of the fetus. The system uses genomic hybridization genetic chips with a diagnostic resolution 100 times greater than the common cytogenetic techniques. A standard amniocentesis is undertaken by the specialist gynecologist and only 8 mL - 10 mL of amniotic liquid are
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Clinical News . . . . . . . 2-58 IFCC News . . . . . . . . . . 57 EFCC Corner . . . . . . . . . 61 Product News . . . . . 24-50 Technical Literature 54-56 Industry News . . . . . . . . 65 International Calendar . 66
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hermo Fisher Scientific has agreed to acquire Phadia, the Swedish-based in vitro diagnostics concern, for US$3.52 billion in cash from Cinven, a private equity firm. Phadia is slated to become part of Thermo Fisher's specialty diagnostics business within its
analytical technologies segment. With Phadia, Thermo Fisher is bound to strengthen its diagnostics range for allergies and autoimmune disorders. Part of Phadias research efforts are focused on developing tests that can identify sensitivity to a large variety of allergies.
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LabMedica
Enzyme Could Diagnose Early Colon Cancer
n enzyme was identified that could be used such a high percent of the cancer cells and virtuto diagnose colon cancer earlier. It is possible ally none are overexpressed like this one, said that this enzyme also could be a key to stopping Cancer Center investigator David Orlicky, PhD, the cancer. associate professor of pathology at the CU medical Scientists studied colon cancers from 40 school and a member of the team. patients and found a form of the enzyme known Up-regulation of this enzyme into colon cancer as ALDH1B1 present in every colon cancer cell in cells and its exact role in the physiology of the 39 out of the 40 cases. The enzyme, which is nortumor cells is now being studied. The team also is mally found only in stem cells, was detected at seeking to understand the substrate, inhibitors, extraordinarily high levels. and activators of ALDH1B1. The study was led by Cancer Center investigaImage: Colored scanning electron micrograph (SEM) tor Vasilis Vasiliou, PhD, professor of molecular toxof the mucosa of the colon of a patient suffering icology at the University of Colorado School of from colon cancer (Photo courtesy of Steve Pharmacy (Denver, CO, USA; www.ucdenver. Gschmeissner / Science Photo Library). edu/academics/colleges/pharmacy/Pages/ SchoolofPharmacy.aspx). Prof. Vasilious laboratory specializes in understanding the role of enzymes called aldehyde VISIT US AT dehydrogenases in drug metabolism, metabolic diseases, cancer, and normal 2011 and cancer stem cells. ANNUAL MEETING Other potential colon cancer bioBooth: 542 markers have been identified in the past, but none thus far are present in
Molecular Prenatal Diagnostic Device Based On Amniocentesis

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put in a tube, which is sent to a laboratory via messenger, exactly as with the usual genetic tests. The new device, known as Amniochip, is able to detect 150 genetic syndromes. This includes currently validated genetic syndromes, including malformations and idiopathic mental deficiency not detected with a conventional kariotyping. As a cell culture is not necessary, the waiting time for the results with the new device is reduced to 48 hours, in contrast to the three weeks it currently takes through conventional kariotype techniques The device for enhanced prenatal diagnosis, developed by Genetadi Biotech SL, (Derio, Spain; www.genetadi.com) is based on Comparative Genomic Hybridization microarray technology. In this technique, the sample under study and a reference sample are marked with different fluorochromes. These DNA hybridize on a crystal that contains thousands of different segments of human DNA. The regions selected on the Amniochip belong to regions of the human genome involved in more than 150 already known syndromes. Subsequently, computer software is used to identify the areas of differential hybridization between the patient and the DNA control, thus indicating the existence of an alteration in its dosage, either a micro-deletion or a microduplication. The prenatal device was presented during the XXVI Human Genetics National Congress, held from March 30 to April 1, 2011, in Murcia, Spain.
LabMedica International June-July/2011
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New Immunoassay Diagnoses Spinal Muscular Atrophy
he enzyme-linked immunosorbent (ELISA) assay kit provides a reliable and widely accessible means to measure SMN protein levels, and it greatly simplifies and accelerates efficacy assessment of potential drugs in clinical trials that are designed to increase SMN protein levels. The assay has been validated for use with human and mouse-cell lysates and tissue homogenates, such as peripheral blood mononuclear cell lysates, and will be marketed through Enzo Biochem, Inc. (New York, NY, USA; www.enzo.com) worldwide sales and marketing group. The kit is the result of a collaborative agreement between Enzo Biochem and the Spinal
Muscular Atrophy Foundation (New York, NY, USA; www.smafoundation.org) for the development of reagents and assays for SMN protein. The availability of an effective SMN ELISA could further enable and expedite drug discovery, development, and therapy for Spinal Muscular Atrophy (SMA), the leading genetic cause of mortality in infants and toddlers. Spinal Muscular Atrophy is a genetic, neuromuscular disease caused by progressive degeneration of nerve cells in the spinal cord that leads to muscular weakness and atrophy and increased risk for early death due to respiratory failure. It is estimated that SMA affects approximately 1 in
6,000 to 1 in 10,000 live births worldwide. The disease is linked to a mutation in or deletion of the SMN1 gene, resulting in reduced levels of SMN protein. An active area of therapeutics development has been elevation of SMN protein levels. Wayne Patton, PhD, Chief Scientific Officer at Enzo Life Sciences, said, During the assay development, the SMA Foundation facilitated the supply of assay kits to affiliated investigators in the US and abroad. This allowed us to validate the assay in-house while simultaneously receiving valuable feedback about assay specifications, performance, and protocols from scientists who will ultimately be using the kits in their studies.
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World Record for Number of Tests in Single DNA Sequencing Analysis

p to now, researchers have been limited to running just a few DNA samples at a time, at a cost of about US$16,000 per run. Swedish researchers have devised a new method that allows 5,000 samples to be run at the same time and at the same price. This cuts the cost per sample result considerably and constitutes a world record for the number of tests run in a single DNA sequencing analysis. We were virtually forced to invent a method for running numerous DNA tests at once. Otherwise our analyses would have taken an incredibly long time and would have cost enormous sums of money, said Dr. Peter Savolainen, a researcher in biology at the Royal Institute of Technology (KTH; Stockholm; www.kth.se). He, his research colleague Dr. Afshin Ahmadian, and the then doctoral candidate Mrten Neiman jointly developed the new technique, which means that DNA sequencing analyses can be performed both in record time and at a remarkably low cost. Today the great majority of samples are run 10 at a time. This yields a cost of SEK 10,000 [about US$1,600] per sample. We have run 5,000 samples at the same time at the same cost, that is, SEK 100,000. This computes to SEK 20 per sample, noted Dr. Savolainen. He pointed out several areas where his and his colleagues new technology can have a great impact. One of them is cancer research; where there is a great need to scan numerous cell samples from many individuals. Another field where our method can be of huge importance is in organ transplants. Many DNA analyses are needed to create a database for matching organ donors with transplant recipients. This will be of major importance to DNA research, stated Dr. Savolainen. He added that now, even before the method is validated, there are several projects at the Science for Life Laboratory (where KTH is involved) in line to use this mode of analysis. Moreover, it is possible to scale up the method so that even more samples can be tested simultaneously.
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Tuberculosis Blood Test Recommended For Key Groups

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EDITORIAL BOARD
Rosa I. Sierra-Amor Mexico Robby Bacchus United Kingdom Edward J. Bottone United States Claus Christiansen Denmark Bernard Gouget France Anders Kallner Sweden Tadashi Kawai Japan John A. Koepke United States John B. Lines United Kingdom Donald Moss United Kingdom Andreas Rothstein Colombia Dmitry B. Saprygin Russia Grard Siest France Andrew Wootton Australia
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www.nice.org.uk), recommend directly using an IGRA blood test in a number of specified instances. These include: in an outbreak situation when large numbers of individuals may need to be screened; recent arrivals from high incidence countries who are from 16 to 34 years old; the immunocompromised and some people with human immunodeficiency virus (HIV); new health service employees who have recently arrived from high incidence countries or who have had contact with patients in a setting where tuberculosis is highly prevalent. These interventions are designed to identify subjects with LTBI so that they can be treated before they convert to active disease. This proactive approach will help to reduce the rates of active TB disease in the UK, which have been rising over the past decade. The IGRA blood test is produced by Oxford Immunotec (Marlborough, MA, USA; www.oxfordimmunotec.com) and sold under the name T-SPOT.TB test. Peter Wrighton-Smith, PhD, CEO of Oxford Immunotec, said, I very much welcome the new guidelines from NICE which recognize the superior accuracy and convenience of IGRA testing in many
Published in cooperation with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and European Federation of Clinical Chemistry and Laboratory Medicine (EFCC).
populations. I am optimistic that the adoption of these guidelines will help to reverse the steadily increasing rates of TB seen in the UK over the past decade. The T-SPOT.TB test is approved for sale in Europe, USA, Canada, and over 40 other countries worldwide and is designed to replace the 115-year-old tuberculin skin test. It offers a substantially more accurate and effective tool for controlling the spread of TB.
Image: Colored scanning electron micrograph (SEM) of Mycobacterium tuberculosis bacteria (yellow) infecting a macrophage white blood cell (Photo courtesy of Science Photo Library).
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Rapid Diagnostic Test for Blood Cancer

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significant degree by measuring specific aberrations in the patients DNA. The test, called the AMLprofiler, uses DNA-chip technology. This new method can replace seven different tests of which three are chromosomal aberrations, two gene-mutations, and two aberrant genetic activities. At present, these tests are often carried out one by one, which takes more time and may result in incomplete availability of important diagnostic information. By contrast, the AMLprofiler delivers these test results in one assay within four days. This reduces the patients period of uncertainty and offers the physician
more time to arrange the most appropriate treatment. The AMLprofiler was developed by Skyline Diagnostics BV (Rotterdam, The Netherlands; www. skyline-diagnostics.com) using the diagnostically approved Affymetrix microarray platform (Affymetrix, Santa Clara, CA, USA; www.affymetrix.com) and specially developed Information Technology (IT) infrastructure. The AMLprofiler is a cost-effective, standardized procedure for diagnosing AML. This test is the worlds first diagnostic DNA chip that makes it possible to measure the activity of disease-related genes anywhere in the world. In addition, it can be of great value for clinical research into new cures for leukemia. The AMLprofiler has received CE-certification. Acute Myeloid Leukemia is the most lethal form of blood cancer, responsible for over 9,000 deaths per year in the US alone. Its progress varies widely in different patients. Research has revealed that the prognosis for this disease can be established to a significant degree by measuring specific aberrations in the patients DNA.
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Image: The AMLprofiler rapid diagnostic test (Photo courtesy of Skyline Diagnostics).
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Influenza Detection Assay Inaugurated for Clinical Trials
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Image: The Enigma Mini-Laboratory (ML) system (Photo courtesy of Enigma Diagnostics).
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has been specifically designed for the particular needs of infectious disease testing. The starting material for analysis is a capped tube containing universal transport medium and a nasopharyngeal swab, which uniquely is inserted directly into the consumable cartridge. The test is anticipated to take less than one hour to perform, and results are displayed in a number of simple to interpret formats by the integrated touch screen. Current methods for viral detection often require many manipulative steps for sample handling and subjective interpretation from highly skilled laboratory technicians, which can take several days to process from the time of collection. The Enigma Mini-Laboratory (ML) Influenza A/B detection assay is produced by Enigma Diagnostics Limited, (Porton Down, UK; www. enigmadiagnostics.com). The Enigma ML system was specifically designed as a rapid fully automated system enabling raw sample to result testing with uncomplicated read-outs and allowing for lower technical skill users. Clinical trial site initiations and the enrollment of subjects for the US based trial began in late March after Enigma worked closely with the US Food and Drug Administration, (FDA; Silver Springs, MD, USA; www.fda.gov) on the clinical trial design for both 510(k) clearance and potential Clinical Laboratory Improvement Amendments-(CLIA) waiver of the system. Up to eight clinical study sites across the US will participate in patient enrollment and onsite testing of the Enigma ML system. John McKinley, Chairman of Enigma Diagnostics, said, It is estimated that over 12 million influenza tests are performed yearly in the USA and typically between 5% and 20% of the US population are infected with seasonal flu every year. Faster and more accurate tests are needed to satisfy this growing market and the features of the Enigma ML instrument make it ideally suited to meet this demand.
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LabMedica
Manual Cytology Preferred to Automatic Method

anual reading of cervical smear slides is superior to automation-assisted reading at detecting abnormal cells. Technology is available which can assist in cervical screening by automatically detecting abnormal fields on a slide and presenting them on an automated microscope, and is analogous to manual cytological microscopy. Scientists at the University of Manchester (Manchester, UK; www.manchester.ac.uk), compared automation-assisted reading of cervical cytology with manual reading using the histological end point of cervical intraepithelial neoplasia grade II (CIN2) or worse (CIN2+). Samples were obtained from women aged 25-64 years undergoing primary cervical screening in Greater Manchester (UK), with small proportions from women outside this age range and from women undergoing colposcopy. Over 70,000 samples were randomized and assessed either by automat-
ed and manual reading or by manual reading only. The study was carried out between March 1, 2006, and February 28, 2009. Liquid-based cytology samples were obtained in primary care, and a small number of abnormal samples were obtained from local colposcopy clinics, from different women, in order to enrich the proportion of abnormals. All of the samples were read in a single large service laboratory. Liquid residues used for Human papillomavirus (HPV) triage were tested in specialist virology laboratory. Histopathology was read by a specialist gynecological pathology team blinded to HPV results and type of reading. The principal finding was that automated reading was 8% less sensitive relative to manual, 6.3% in absolute terms. The FocalPoint Slide Profiler (Becton Dickinson, Franklin Lakes, NJ, USA; www.bd.com), especially No Further Review was very reliable and, if restricted to routine screen-
ing samples, as less than 1% of CIN2+ would have been missed. Automated and manual were very similar in terms of cost-effectiveness despite a 60% - 80% increase in productivity for automation-assisted reading. The authors concluded that the inferior sensitivity of automation-assisted reading for the detection of CIN2+, combined with an inconsequential increase in specificity, suggests that automation-assisted reading cannot be recommended for primary cervical screening. Henry Charles Kitchener, MD, professor of gynecological oncology and lead author said, Although automated reading could achieve productivity gains in terms of the numbers of slide checked, on the basis of this evidence there does not appear to be sufficient grounds to recommend automation. The trial also found that the cytoscreeners preferred manual reading as automationassisted reading was monotonous. The article was published in January 2011, in Lancet Oncology.
Blood Glucose Measurements Can Be Made From Tears

new sensor would enable people to draw tear fluid from their eyes to get a glucose-level test sample. Glucose in tear fluid may give an indication of glucose levels in the blood as accurately as a test using a blood sample. The technology was designed by bioengineer Jeffrey T. LaBelle, a professor in the School of Biological and Health Systems Engineering, one of the Arizona State University (Tempe, AZ, USA; http://asunews.asu.edu) Ira A. Fulton Schools of Engineering. Prof. LaBelle is leading the ASU-Mayo team along with Mayo Clinic (Scottsdale, AZ, USA; www.mayoclinic.org/arizona) physicians Curtiss B. Cook, MD, an endocrinologist, and Dharmendra (Dave) Patel, MD, chair of Mayos Department of Surgical Ophthalmology. Many people with diabetes suffer due to the difficulty of managing their blood glucose levels. It is recommended that they monitor their own glucose levels, but current monitoring devices typically require patients to perform the painful task of pricking their finger to draw blood for a test sample and many patients must do it several times each day. This new technology might encourage patients to check their blood sugars more often, which could lead to better control of their diabetes by a simple touch to the eye, said bioengineer Jeffrey T. LaBelle. The major challenges are performing the test quickly, efficiently, with reproducible results, without letting the test sample evaporate and without stimulating a stress response that causes people to rub their eyes intensely, Prof. LaBelle said. Because of its potential impact on health care, the technology has drawn interest from BioAccel (Phoenix, AZ, USA; www.bioaccel.org), an Arizona nonprofit that works to accelerate efforts to bring biomedical technologies to the marketplace. With funding provided by BioAccel, the scientific team will conduct critical experiments to determine how well the new device correlates with use of the current technology that uses blood sampling, said Ron King, BioAccels chief scientific and business officer.
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LabMedica
HER2 Gene Status Accurately Assessed in Breast Cancer Tissue

fully automated system easily and accurately assesses HER2 gene status in breast cancer tissue. The system uses an optimized ready-to-use HER2 fluorescence in situ hybridization (FISH) reagent kit with a BOND protocol to produce consistent, high quality stained slides. The system enhances the laboratory workflow, increasing efficiency, and enabling the laboratory to provide a responsive service to their clinicians and clients. Designed by Leica Microsystems (Buffalo Grove, IL, USA; www. leica-microsystems.com) the HER
FISH system detects amplification of the HER2/neu gene via FISH in formalin-fixed, paraffin-embedded (FFPE) human breast cancer-tissue specimens. The Leica HER2 FISH System is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Designed for easy and accurate assessment of HER2 gene status in breast cancer tissue, the Leica HER2 FISH System combines the use of the gold standard PathVysion HER2 FISH probes, supplied by Abbott Molecular Inc. (Des Plaines, IL, USA; www.abbottmolecular.com) with Leicas industry-leading BOND automated platform, delivering accurate results for diagnostic confidence. The Leica HER2 FISH System was compared to the Abbott Molecular PathVysion HER2 DNA probe kit assay on an independent set of samples and found to provide acceptably concordant results. The actual correlation of the results of the Leica HER2 FISH System to clinical outcome has not been established.
Image: Breast Cancer Specimen stained with the Leica HER2 FISH System showing amplification of the HER2 gene (Photo courtesy of Leica Microsystems).
Blood Biomarker Linked to Risk of Alzheimers

ncreased levels in the blood of a specific biomarker are significantly associated with the prevalence and severity of Alzheimers disease (AD), but not with the risk of onset of new disease. The protein clusterin, also known as apolipoprotein J, have been found to be increased in brain and cerebrospinal fluid of patients with AD, and have been suggested to be involved in the pathogenesis of AD. Scientists at Erasmus University Medical Center (Rotterdam, The Netherlands; www.erasmusmc.nl) analyzed the plasma levels of clusterin measured at baseline from 1997 to 1999, in 60 individuals with prevalent AD, a random subgroup of 926 participants, and an additional 156 participants diagnosed with AD during the average 7.2 years of follow-up, until January 2007. Clusterin levels were analyzed via multiplex immunoassay on a human multianalyte profile at the Rules-Based Medicines multiplexed biomarker testing laboratory, (Austin, TX, USA; www. rulesbasedmedicine.com). The lowest detectable level was 1.3 g/mL. The intra-assay variability was less than 4% and the interassay variability was less than 13%.
The scientists found that the likelihood of prevalent AD increased with increasing plasma levels of clusterin, with the odds increased by 63% for every standard deviation increase in clusterin levels, after adjusting for age, sex, education level, apolipoprotein E status, diabetes, smoking, coronary heart disease, and hypertension. Among patients with AD, higher clusterin levels were associated with more severe disease. There was no statistically significant association of plasma clusterin levels with new AD during total follow-up or with new AD within or after three years of baseline. The results for all-cause dementia and vascular dementia were similar. The authors of study concluded that the data from the general population show that increased plasmaclusterin levels are associated with prevalent AD and are higher in more severe cases of AD. However, increased levels of clusterin do not precede development of AD and therefore are not a potential early marker of subclinical disease. The study was published in the April 2011 edition of the Journal of the American Medical Association (JAMA).
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LabMedica
Assay Detects Bacterial Toxin That Causes Diarrhea

n assay that can detect the toxin B gene associated with Clostridium difficile infection (CDI) in stool samples is now available. The assay is fully automated and works on the GeneXpert Dx System to detect toxin gene sequences associated with toxigenic C. difficile. The GeneXpert Dx System consists of an instrument that houses single-use disposable cartridges, a personal computer, and software that allow a laboratory technician to run tests and view test results quickly. The test, Xpert C. difficile/Epi assay determines if C. difficile is in a patients stool and also detects if the C. difficile is the epidemic 027/NAP1/BI strain, which has been associated with a marked increase in the severity and incidence of CDI in North America and Europe over the past decade. The test utilizes automated real-time polymerase chain reaction (PCR) to detect C. difficile DNA. The test is intended for use as an aid in the diagnosis of CDI. The detection
of the 027/NAP1/B1 strain is for epidemiological purposes only and should not be used to determine or monitor treatment. Health care facilities should monitor the number of C. difficile infections and, especially if rates at the facility increase, the severity of disease and patient outcomes. Both the Xpert C. difficile/Epi assay and GeneXpert Dx System are manufactured by Cepheid, (Sunnyvale, CA, USA; www.cepheid.com). The US Food and Drug Administration, (FDA; Silver Springs, MD, USA; www.fda.gov), have cleared the test for clinical laboratory use. Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics Device Evaluation and Safety in the FDAs Center for Devices and Radiological Health, said, Healthcare professionals in the infectious disease community who have seen various outbreaks of CDI associated with aggressive strains in recent years, now have a new testing tool to detect this disease.
Image: The Xpert C. difficile/Epi assay (Photo courtesy of Cepheid).
Blood-Based Assay Detects vCJD Prion Infection

prototype blood test for diagnosis of variant Creutzfeldt-Jakob disease (vCJD) in symptomatic individuals could allow development of large-scale screening tests for asymptomatic vCJD prion infection. A solid-state binding matrix was utilized to capture and concentrate disease-associated prion proteins; this was coupled to direct immunodetection of surface-bound material. Scientists from the Medical Research Council (MRC) Prion Unit, based at University College London (United Kingdom; www.prion.ucl. ac.uk), working with the National Prion Clinic at the National Hospital for Neurology and Neurosurgery (NHNN; London, United Kingdom; www.uclh.nhs.uk/ourservices/ ourhospitals/nhnn) tested 190 blood samples, including 21 from individuals known to have vCJD. The blood test was able to detect blood spiked with a dilution of vCJD to within one part per ten billion 100,000 times more sensitive than any other method developed so far. Variant CJD, the human form of bovine spongiform encephalopathy (BSE) commonly known as mad cow disease first emerged in 1995. The disease, which affects the brain, is
believed to have passed from cattle to humans through infected food. It causes personality change, loss of body function, and eventually death. Prions, the infectious proteins that cause vCJD and other fatal prion diseases, can inhabit a persons body for up to 50 years before presenting symptoms. During this time there is a chance a carrier of vCJD infection could pass on the infection to others, for example through blood transfusion or even through surgical and medical instruments because prions can easily attach onto metal surfaces. The work was published online in the February 3, 2011, edition of the Lancet. Lead author Dr. Graham Jackson, program leader at the MRC Prion Unit, said: This test comes at the end of many years of meticulous, painstaking research in our Unit and the NHS National Prion Clinic. Although further larger studies are needed to confirm its effectiveness, its the best hope yet of a successful early diagnostic test for the disease. This test could potentially go on to allow blood services to screen the population for vCJD infection, assess how many people in the UK are silent carriers and prevent onward transmission of the disease.
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LabMedica
Rapid Blood Test Detects Damaged Cardiac Muscle
microwave-accelerated and metal-enhanced fluorescence (MA-MEF) technique was used to detect the protein troponin I (TnI), a specific indicator of damage to the heart muscles. The technique is based on the combined use of low-power microwave heating, silver nanoparticle films (SNFs), and fluorescence spectroscopy for the detection of TnI from human whole blood samples. The silver nanoparticles were deposited onto amine-modified glass microscope slides by use of Tollens reaction scheme and characterized by optical absorption spectroscopy and scanning electron microscopy. The
detection of TnI from buffer solutions and human whole blood samples on SNFs was carried out by using fluorescence-based immunoassays at room temperature. A control immunoassay, which took two hours total assay time, was compared with the microwave heating MA-MEFbased immunoassay, which took one minute total assay time. Scientists at Morgan State University (Baltimore, MD, USA; www.morgan.edu) found that the lower limits of detection for TnI from buffer solutions in the control immunoassay and MA-MEFbased immunoassay were 0.1 g/L and 0.005 g/L, respectively. However,
they were unable to detect TnI in whole blood samples in the control immunoassay owing to the coagulation of whole blood within five minutes of the incubation step. The use of the MA-MEF technique allowed detection of TnI from whole blood samples in one minute with a lower detection limit of 0.05 g/L. The authors concluded that the MA-MEFbased immunoassay is one of the fastest reported quantitative detection methods for detection of TnI in human whole blood and has low detection limits similar to those obtained with commercially available
immunoassays. Troponins are measured in the blood to differentiate between unstable angina and myocardial infarction in patients with chest pain or acute coronary syndrome. A patient who had suffered from a myocardial infarction would have an area of damaged heart muscle and so would have elevated cardiac troponin levels in the blood. The study was published online on March 11, 2011, in Clinical Chemistry.
Image: Light micrograph of human cardiac muscle following infarction (Photo courtesy of Astrid & Hanns-Frieder Michler / Science Photo Library).
Blood Proteins Predict Ectopic Pregnancy

contd from cover
identified almost 70 proteins occurring in unusual levels in the blood in patients with EPs. One of the proteins is called Adam12 and it might be a particularly good early warning sign for EP, because it appears at levels that are 20 times lower than in normal pregnancies. Ectopic pregnancy happens when an embryo does not attach normally inside the mothers uterus, but instead attaches and begins growing elsewhere. Most occur inside one of the Fallopian tubes, which link the ovaries to the uterus. As the embryo grows, the tube can rupture, resulting in the loss of the embryo and threatening the life of the pregnant woman. Ectopic pregnancies occur in about one in 40 to 100 pregnancies, and are a leading cause of death in the first trimester of pregnancy. There is no single proven blood test for ectopic pregnancy, and current diagnosis relies on the use of ultrasound. The study was carried out by scientists at The Wistar Institute (Philadelphia, PA, USA; www.wistar.
org) and the University of Pennsylvania School of Medicine (Philadelphia, PA, USA; www.med.upenn. edu). It was reported in the American Chemistry Societys February 16, 2011, issue of the Journal of Proteome Research. Here we describe a group of proteins that, with further refinement, could make a simple blood test for ectopic pregnancy, said David W. Speicher, PhD, professor and coleader of Wistars Molecular and Cellular Oncogenesis Program and director of Wistars Center for Systems and Computational Biology. This is also a proof-of-principle demonstration of a new method for the discovery of new blood-borne markers that may serve as diagnostic blood tests to detect or predict a variety of clinical conditions and diseases, from ectopic pregnancy to cancer. The next step is clearly to test the candidate biomarkers on a larger, independent patient group, both individually and in multibiomarker panels, the report states.
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LabMedica
Lyme Disease Distinguished from Chronic Fatigue Syndrome

nique proteins in spinal fluid can distinguish between patients suffering from neurologic post-treatment Lyme disease (nPTLS) and those with the Chronic Fatigue Syndrome (CFS). Investigators found that both conditions involve the central nervous system and that protein abnormalities in the central nervous system are causes and/or effects of both conditions, which present with similar clinical symptoms. Spinal fluid was analyzed from three groups of people. One group consisted of 43 patients who fulfilled the clinical criteria for Chronic Fatigue Syndrome (CFS). The second
group consisted of 25 patients who had been diagnosed with, and treated for, Lyme disease but did not completely recover. The third group consisted of 11 healthy control subjects. The fluids were analyzed using high-powered mass spectrometry and protein separation techniques. Each group had more than 2,500 detectable proteins. The team discovered that 738 proteins were identified only in CFS but not in either healthy normal controls or in patients with nPTLS; 692 proteins were found only in the nPTLS patients. The study team was led by Steven E. Schutzer, MD, of the
University of Medicine and Dentistry of New Jersey (Newark, NJ, USA; www.umdnj.edu), and Richard D. Smith, PhD, of Pacific Northwest National Laboratory (Richland, WA, USA; www.pnl.gov). The findings were, published in the February 23, 2011 edition of the journal PLoS ONE. According to Dr. Schutzer, spinal fluid proteins can probably be used as a marker of disease. One next
step will be to find the best biomarkers that will give conclusive diagnostic results, he said. In addition, if a protein pathway is found to influence either disease, scientists could then develop treatments to target that particular pathway.
Image: Colored Scanning Electron Micrograph (SEM) of Borrelia burgdorferi bacteria, the cause of Lyme disease in humans (Photo courtesy of the Eye of Science).
Flow Cytometry Assay Differentiates Active from Latent Tuberculosis

flow cytometry-based assay identifies parameters of the immune response correlated to protection against tuberculosis (TB). The assay derives functional signatures of immune responses to Mycobacterium tuberculosis (Mtb), the causative organism of TB, such as the cytokines and leucocytes, at different stages of the disease. The new tool has been developed by scientists at the University of Lausanne, (Lausanne, Switzerland; www.unil.ch), that distinguishes between active and latent TB. A study recruited 283 participants from a hospital in Switzerland based on positive Mtb-specific interferon gamma (IFN) enzyme-linked immunosorbent spot assay (Becton Dickinson, Allschwil, Switzerland; www.bdbiosciences. com). A validation cohort of 114 participants was obtained from two clinical sites from Switzerland and South Africa. For the flow cytometry analysis cells were stained with antibodies specific for a range of cytokines. The scientists were able to show that the immune response by the cytokines such as tumor necrosis factor alpha (TNF-, interleukin 2 (IL-2) and IFN-, were correlated to the different stages of tuberculosis disease.
The flow cytometry-based assay readout is focused on the immune response and not on microbiological parameters, thus explaining its reliability and quickness. The sensitivity of the assay was 62% and specificity was 92% for the different stages of TB. The results showed substantial increase in the proportion of singlepositive TNF- Mtb-specific CD4+ T cells, a type of white cell, in subjects with active disease. This parameter was the strongest predictor of diagnosis of active disease versus latent infection. Giuseppe Pantaleo, MD, professor of medicine and lead author of the study, said, This assay and the functional signatures of TB-specific immune responses are not only relevant for discriminating between active TB disease and latent infection, but may be also instrumental in monitoring the response to TB therapy. The authors concluded that although the flow cytometry-based assay requires specific equipment and skillful laboratory personnel, further technological development is already under way to make the assay widely accessible. The study was published online on February 20, 2011, in Nature Medicine.
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LabMedica
Blood Biomarker Gauges Alzheimers Prognosis
biomarker in the blood has been identified that tracks how effectively the immune system is able to clear the brain of amyloid beta, which forms the plaques that are the hallmark of Alzheimers disease. The biomarker is the gene that encodes for the enzyme beta-1,4-mannosyl-glycoprotein 4-beta-Nacetylglucosaminyltransferase, (MGAT3), which is essential in clearing amyloid beta, and is expressed differently in heterogeneous groups of Alzheimers patients. Scientists at the University of California Los Angeles (UCLA; USA; www.ucla.edu) drew blood samples from 20 Alzheimers disease patients and 20 healthy controls and then isolated critical immune cells from the blood called macrophages, which are responsible for the phagocytosis of amyloid beta and other waste products in the brain and
body. These immune cells were incubated overnight with amyloid beta to test the cells ability to express the gene MGAT3. They also added a synthetic form of curcumin to some of the cells to gauge the effect it had on MGAT3 expression and the absorption of amyloid beta. The scientists identified three groups of Alzheimers patients: Type 0 patients who had very low expression of MGAT3 and very low absorption rates of amyloid beta; Type I patients who also had low expression of MGAT3 and low amyloid beta absorption rates, but the strength of the MGAT3 message and the absorption of amyloid beta increased when the investigators stimulated the macrophages with synthetic curcumin; and Type II patients who initially had high amyloid beta absorption rates, but when scientists added synthetic curcumin, MGAT3 expression lessened and absorption
was reduced. Fourteen of the 20 Alzheimers disease patients have been followed for two years, and researchers noted that those who were Type 0 had a worse two-year prognosis regarding the loss of their ability to live independently than the other two types of patients. Milan Fiala, MD, the lead author of the investigation, said, A larger clinical trial needs to be completed to validate findings from this pilot study. He said that while vitamin D3 seems to be helpful to most people, the benefits of synthetic curcumin are more individualized, depending on the patient. In the future, a commercially available test may be able to check for MGAT3 immunity. The finding may be useful in providing more highly individualized disease prognoses in the future. The study was published online in January 2011, in the Journal of Alzheimers Disease.
Novel Biomarkers Linked to Asthma and COPD

our novel biomarkers have been identified that may help in the diagnosis and management of asthma and chronic obstructive pulmonary disease (COPD), according to a study conducted by Australian researchers, who determined the biomarkers may be utilized in different combinations to effectively identify patients with either of the airway diseases. The studys findings were published online in March 2011 ahead of the print edition of the American Thoracic Societys American Journal of Respiratory and Critical Care Medicine. Using a proteomics approach, we have identified a panel of four blood-based biomarkers that, when used in combination, can discriminate between healthy controls, asthmatics, and individuals with COPD, and has the potential to be a valuable tool in the clinical diagnosis of respiratory disease, said Peter G. Gibson, MD, conjoint professor at the University of Newcastles School of Medicine and Public Health (Newcastle, Australia; www. newcastle.edu.au/school/medicine-publichealth). The proteins in the diagnostic biomarker panel are all involved in the regulation of inflammation, and usually function as anti-inflammatory proteins. These results were confirmed in a second clinical population of older adults with airflow obstruction. The proteins identified in the study are predominantly liver-synthesized proteins that can have significant anti-inflammatory activity through the inhibition of oxidative stress, which has been implicated in several diseases, including heart disease, Alzheimers disease, and Parkinsons disease. To identify potential biomarkers, blood samples were collected from 43 subjects with a mean age of 48 years, including 21 with asthma, 5 with COPD and 17 healthy controls. Using proteomic techniques, plasma proteins were separated from all blood samples. Once protein biomarkers were identified and selected, the researchers measured the biomarkers abilities, individually and in combination, to differentiate between the groups of patients. To confirm their results, the researchers conducted two additional evaluations. In the first
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assessment, the original group was supplemented with an additional seven asthmatics and nine patients with COPD, and repeated the biomarker assessment. The second assessment involved a separate population of 73 older subjects (over 55 years), including 14 with asthma, 22 with COPD, 14 with both conditions, and 23 healthy controls. Results were confirmed in both validation groups. Identifying biomarkers that are involved in the development of airway diseases may allow clinicians to diagnose the diseases in their earlier, and often more treatable, stages, Dr. Gibson noted. Our study identified a panel of highly discriminatory proteins that could be extremely useful in a clinical context, Dr. Gibson said. Since these biomarkers are detectable in blood, which is readily obtainable from patients, and substances are currently available for testing the abundance of these proteins, this panel of biomarkers has the potential to become an extremely useful addition to the clinical diagnosis and management of respiratory disease. Dr. Gibson noted proteomics played a key role in the study, which was funded by the Australian government as part of its Cooperative Research Center for Asthma and Airways program, and suggests the protein-based techniques may prove vital in future studies of biomarkers. Combined with well-defined clinical groups and advanced statistical analyses, we have shown that proteomics is a powerful tool for the identification of novel disease biomarkers, he said. The study is a good example of how high quality biological science can be translated effectively to a useful result for people with asthma and COPD. Future work is planned to study these markers in the lungs of patients with asthma and COPD, and apply the results in different clinical settings.
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LabMedica
Elevated Metabolites Signal Diabetes Risk

ncreased levels of amino acids in the blood can identify individuals at risk of developing diabetes mellitus type 2. Amino acids, amines and other polar metabolites can be profiled in baseline blood specimens by liquid chromatographytandem mass spectrometry (LC-MS), and correlated with disease progression. A team led by scientists at Massachusetts General Hospital (MGH; Boston, MA, USA; www.massgeneral.org) recently found that the levels of five amino acids, identified by LC-MS, indicated increased diabetes risk in a general population. Out of 2,400 normoglycemic participants who entered the study in 1991 and 1995, 201 developed type 2 diabetes during the subsequent 12 years. Using the baseline blood sam-
ples, the research team measured levels of 61 metabolites in 189 participants who later developed diabetes and 189 diabetes free individuals, who were matched for age, sex, and diabetes risk factors. The analysis found that elevations in five amino acids: isoleucine, leucine, valine, tyrosine, and phenylalanine, were significantly associated with the later development of type 2 diabetes and could also differentiate, among individuals with traditional risk factors such as obesity, and those most likely to actually develop diabetes. The investigators found that measuring combinations of several metabolites, as opposed to a single amino acid, improved risk prediction. Overall, in individuals closely matched for traditional risk factors for type 2 diabetes, those with the highest
levels of the three most predictive amino acids had a four to five times greater risk of developing diabetes than did those with the lowest levels. These findings underscore the potential key role of amino acid metabolism early in the pathogenesis of diabetes and suggest that amino acid profiles could aid in diabetes risk assessment. Thomas J. Wang, MD, the lead author of the study, said, These findings could provide insight into metabolic pathways that are altered very early in the process leading to diabetes. They also raise the possibility that, in selected individuals, these measurements could identify those at highest risk of developing diabetes so that early preventive measures could be instituted. The study was published online on March 20, 2011, in Nature Medicine.
Biochemical Markers Used in Diagnosis of Nasopharyngeal Cancer

etabolic profiling of patients with nasopharyngeal carcinoma (NPC) revealed that four chemical in their sera were useful as diagnostic markers. Serum metabolite levels can be ascertained by using both liquid and gas chromatography with mass spectrometry techniques (LC/GC-MS) and followed in the blood sera of patients suffering from carcinoma before, during, and after therapy. In a study performed at Jinan University, (Zhuhai, China; www.jnu.edu.cn), scientists evaluated 51 serum metabolites in 49 NPC patients, 37 throat cancer patients and 40 healthy controls. Nasopharyngeal biopsy tissues were collected from 31 patients with NPC and 27 healthy people who were pathologically diagnosed as nonnasopharyngeal carcinoma. High metabolites were selected and confirmed in NPC tissues. Sensitivity and specificity were appraised for 53 NPC diagnoses. The LC/GCMS profiles were significantly different among the three groups. In these profiles, 51 metabolites were considered endogenous metabo-
lites, which included organic acids, amino acids, and fatty acids involved in multiple biochemical processes. These were studied further for their potential to represent the metabolic pattern of the disease and recovery states. The results showed that four metabolites, kynurenine, N-acetylglucosaminylamine, N-acetylglucosamine and hydroxyphenylpyruvate gradually increased from normal nasopharyngeal, atypical hyperplasia to NPC. Their sensitivity and specificity of the four metabolites were respectively 79% and 71%, 78% and 69%, 83% and 68%, 84% and 73% for NPC diagnosis. Three other metabolites, stearic acid, N-acetylgalactosamine and glycine did not change. This implies that these four metabolites may serve as potential markers as after radiotherapy, the four metabolites decreased gradually, tended to a normal level, and were associated with rate of tumor reduction. The study was published online on March 12, 2011, in Clinical Biochemistry.
Blood Test for Donor DNA Improves Detection of Rejection

sophisticated molecular method has been used to detect the DNA of the donor in the blood of heart transplant patients, which will aid in early recognition of rejection. An increase in the amount of the donors DNA in the recipients blood is one of the earliest detectable signs of organ rejection and can be evaluated using a microfluidic digital polymerase chain reaction (PCR). Scientists at Stanford University School of Medicine (Stanford, CA, USA; www.stanfordmedicine.org) developed advanced genome-sequencing technology to measure levels of donor DNA released when cells in the transplanted heart are damaged as occurs early in the rejection process. A study of 39 samples from women with male hearts showed that the prevalence of the Y chromosome in the recipients blood increased significantly, from a norm of about 0.5% of the total, up to 8%, during episodes of rejection. They also used an existing blood test that relies on the expression profile of 20 genes in a patients blood sample to determine whether the body has launched an attack on the donated organ.
The original Allomap blood test is produced by XDX Diagnostics, (Brisbane, CA, USA; www.xdx.com). The two methods in tandem will allow the noninvasive monitoring of the health of many transplanted organs, including hearts, lungs and kidneys. The analysis of the cell-free DNA circulating in the blood of heart transplant recipients showed significantly increased levels of cell-free DNA from the donor genome at times when an endomyocardial biopsy independently established the presence of acute cellular rejection in the heart transplant recipients. Rejection episodes corresponded to levels of donor DNA approaching 3% to 4%, so when the patients were successfully treated with immunosuppressants, the amount of the donor DNA in the blood decreased to less than 1% of total free DNA. The high throughput shotgun sequencing method that was developed leads to a universal noninvasive approach to monitoring organ health. The study was published online on March 28, 2011, in the Proceedings of the National Academy of Sciences of the Unites States of America (PNAS).
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The ReQuest kit offers enhanced sensitivity, specificity, accuracy, and precision. The kit provides reliable, user-friendly, and cost-effective diagnostic test methods for TORCH, autoimmune panels, and infectious disease markers, among others.
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The SPAPlus is a dedicated specialist protein analyzer for serum, plasma, and urine assays including Freelite and Hevylite. The systems compact design allows for an easy fit in any lab, and it can be run beside a chemistry or electrophoresis platform.
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Diagnostic for Heart Attack and Stroke Risk Launched

cardiovascular disease (CVD) risk assay will enhance cardiologists ability to assess heart attack and stroke risk. The laboratory-developed assay is based on gamma prime fibrinogen, a naturally occurring clotting protein in human blood. This biomarker is strongly associated with cardiovascular disease. Developed by Gamma Therapeutics (Portland, OR, USA; www.gamma-therapeutics.com), the CVD assay will be marketed exclusively by Health Diagnostic Laboratory Inc. (HDL; Albuquerque, NM, USA; www.hdl.com), which also will lead the BETA testing of the assay for the US Food and Drug Administration (FDA; Silver Springs, MD, USA; www.fda.gov) approval. Despite current diagnostic tests to assess heart disease or stroke risk, millions die each
year from fatal heart attacks 500,000 in the US alone in 2009 many of which were preventable with more predictive testing methods. Launch of the partnership between HDL, Inc. and Gamma Therapeutics represents a combined effort to advance the preventative model for chronic disease management, based on the recent shift in the way physicians test for lifethreatening conditions. The results are simple, said Tonya Mallory, CEO and cofounder of HDL, Inc. Thanks to advanced testing, it [is] now possible to reveal risk factors and biomarkers for cardiovascular and related diseases. The partnership with Gamma Therapeutics demonstrates HDL, Inc.s ongoing goal to provide best of breed biomarkers, such as this new assay.
Image: False color scanning electron micrograph of human red blood cells with normal fibrinogen threads (Photo courtesy of Manfred Kage / Science Photo Library).
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LabMedica
Class II Biosafety Cabinets Have Flexible Modular Design

lass II style clean air and biocontainment enclosures, designed for high-volume robotic and automated equipment applications, have a flexible modular design. BioPROtect enclosures are designed for aseptic product preparation and biologic investigation involving agents of low to moderate risk. The BioPROtect III may be exhausted back into the laboratory or connected to an in-house exhaust system. The BioPROtect III (BPIII) and BioPROtect Jr (BPJr) air containment units accommodate high-throughput robotic systems (including ancillary devices), ultracentrifuges, flow cytometers, aerosol generators, and other large laboratory equipment. Both models are ideal for high-throughput screening, combinatorial chemistry, immunology, tissue culture, clinical research, drug discovery, molecular biology, and quality control assays. While offering clean air and biocontainment, the BioPROtect III model allows total access to the 4.64 m3 interior work area with combination double doors. BioPROtect III Jr. has a single door access with a 2.2 m3 interior volume. The Baker Company (Sanford, ME, USA; www.bakerco.com) is offering the Class II biosafety cabinets BPIII/BPJr. The air inflow rate is 30 m/minute; recirculated/exhausted air: 70%/30%; and internal dimensions 259 cm (or 124.4 cm) x 92.7 cm x 193 cm. The cabinets high-performance airflow system provides optimum protection against airborne particulates and aerosols for personnel, product, and
the environment. HEPA-filtered, particulate-free airflow throughout the work area provides an aseptic environment and minimizes cross-contamination. The modular construction of the enclosures allows disassembly for shipping, delivery, and placement; cabinet design simplifies assembly and installation prior to certification.
Image: The BioPROtect III clean air equipment containment enclosure (Photo courtesy of The Baker Company).
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LabMedica
Clinical Chemistry Analyzer Offers Increased Efficiency and Productivity

he latest addition to a series of clinical chemical analyzers provides increased efficiency and productivity. The RX series of four clinical chemistry analyzers provide quality results at every phase of clinical development. The analyzers offer an extensive test menu enabling laboratories to avoid the costly outsourcing of routine safety testing. The latest addition to the series is the RX suzuka, a fully automated random access analyzer capable of carrying out up to 1200 tests per hour including ISEs. The RX monza is the smallest of the series; it is a semi-automated clinical analyzer ideal for low throughput testing in clinical, research laboratories, and specialized clinics. The RX daytona is a compact benchtop fully automated clinical analyzer with a throughput of 180 photometric tests and 270 ISE tests per hour. The RX
imola is a fully automated and random access benchtop analyzer capable of performing 400 photometric tests and 240 ISE tests per hour. Each system requires only a small sample volume. Reagent volume required is also low, reducing cost per test. The RX Series require no extra consumables for example, permanent pyrex cuvettes are used, providing considerable cost savings. Randox Pharma Services (Crumlin , UK; www. randoxpharmaservices.com) markets the RX series of analyzers. The company also offers an extensive test menu consisting of over 120 enzymatic, substrate, and immunoturbidimetric assays. In addition to the analyzers, a Quality Control (QC) package is provided. Randox quality controls cover over 170 parameters and are of high quality, accurate, and stable ensuring valid clinical
results. Customized QC is also available in addition to RIQAS, the largest global EQA scheme.
Image: The RX imola random access benchtop analyzer (Photo courtesy of Randox).
Biothreat Assay Offers Rapid Detection of Dangerous Microorganisms

n assay, designed to detect and distinguish 17 different biothreat pathogens, enables rapid and accurate detection of potentially dangerous microorganisms that could pose serious threats to human health. The PLEX-ID Biothreat Assay permits analysis of direct specimens, such as blood, water, food, and air filter samples, and provides results in less than eight hours. The seventeen bioagents targeted in the new test, include Bacillus anthracis, Escherichia coli, Salmonella, Ebolavirus, and avian influenza viruses. PLEX-ID offers the unique capability to detect and identify these, and other, bacterial and viral biothreat agents while also differentiating similar organisms. A high-throughput technology introduced by Abbott (Abbott Park, IL, USA; www.abbott.com) PLEX-ID offers rapid and broad identification, detailed genotyping and characterization, and recognition of emerging organisms. The system employs a combination of molecular technologies, including
polymerase chain reaction (PCR) for gene amplification and mass spectrometry analysis to characterize known and unknown organisms rapidly. The assay, in addition to identifying a broad range of bacteria, viruses, fungi, and parasites, also provides information about drug resistance, virulence, and strain type. Anticipated public health and biodefense applications include epidemiologic research and identification of emerging or previously unknown agents. In addition, the system is being used for forensic characterization of human samples. At the American Society for Microbiology Conference on Biodefense and Emerging Diseases held in Washington DC (USA) from February 6-9, 2011, Abbott and the Midwest Research Institute (Kansas City, MO, USA; www.mriresearch. org) reported that an independent evaluation of the PLEX-ID Biothreat assay showed that it provides highly sensitive and specific results for biothreat detection in environmental air sample analysis.
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LabMedica
Biosensor Platform Developed for POC Diagnosis of Cerebrovascular Disease

consortium has been formed to develop an immunoassay detection device for the diagnosis of cerebrovascular disease. The device has to be standalone so that it may be used for emergencies such as when diagnosis is required in an ambulance, emergency room, or as part of a rapid near-patient laboratory test in a hospital environment. Therefore, a number of key processes must be completed automatically within the system. The biosensor platform needs to be able to manipulate liquid samples and deliver any biomarkers that are present to the surface of the sensor in a manner that ensures accurate and reliable detection. The EUR 3.6-million P3SENS consortium project (www.p3sens-project.eu), which is being coordinated by Multitel (Mons, Belgium; www.multitel.be), has been making good progress. The aim of the project is to design, develop, and manufacture robust microfluidic systems that can be used for fast and cost-effective sample transport and that also contain simple sample preparation functions. Preliminary microfluidic structures have been designed taking into consideration the proposed layout of the sensor chip and the material requirements. The microfluidics system is to contain six parallel individual channels with different components supplying the integrated functions of washing and mixing. Members of the consortium include: The Research Institute for Technical Physics and Materials Science (MFA; Budapest Hungary; www.mfa.kfki.hu), which is mainly responsible for the immobilization and optical characterization of receptor protein layers using label-free optical waveguide based sensors, and for the manufacture of the microfluidic polymer structure; and Micronova, a center for micro- and nano-technology located in Espoo, Finland (www. micronova.fi) and run jointly by VTT Technical Research Center of Finland (VTT; Finland; www.vtt.fi) and Aalto University (Finland; www.aalto.fi/en). VTTs main responsibilities in the project are the development of nanoimprint lithography (NIL) for patterning waveguides and photonic crystals into the polymer, the design and fabrication of NIL-based photonic chips, and the integration of photonic and fluidic functions in a single chip. Other institutes in the consortium include The
Biomedical Proteomics Research Group (BPRG) at Geneva University (Switzerland; www.unige.ch); The James Watt Nanofabrication Center (JWNC) in Glasgow University (Scotland; www.jwnc.gla. ac.uk); Bayer Technology Services GmbH (Leverkusen, Germany; www.bayertechnology.com); and Stratophase, a VC-funded spin-out from the University of Southampton in UK (www.stratophase. com).
Image: The mixing of fluorescent human serum albumin [0,1 mMol/mL] and buffer solutions in the Herring-Bone type microfluidic mixer (Photo courtesy of the P3SENS consortium).
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Biomarker for AKI Responds Before Other Status Markers

novel biomarker for diagnosing acute kidney injury (AKI) responds earlier than other renal status markers such as serum creatinine, and shows a proportionate response to injury. Using only a few drops of plasma or urine the new, rapid NGAL test gives results in just 10 minutes and thus addresses the widespread demand for urgent determination of kidney damage. The test provides a new way to identify patients at risk of developing potentially severe acute kidney injury (AKI) - 24-72 hours before the problem would otherwise be detected. The NGAL test is designed to run on open channels of chemistry ana-
lyzers from various manufacturers, effectively giving most laboratories a convenient and easy way to establish kidney damage. NGAL levels rise rapidly after renal injury and have been used in a variety of clinical situations including intensive care, emergency medicine, renal transplantation, and procedures involving the use of intravenous (I/V) contrast media and other nephrotoxic agents. BioPorto Diagnostics (Gentofte, Denmark; www.bioporto.com) is now launching the CE-marked NGAL test for diagnostic use in Europe. This means that the company is starting to sell the test to European hospitals, where the
physicians will utilize the tool for combating the harmful effects of acute kidney injury. In November 2010, BioPorto prelaunched the NGAL test for research use, and since then the test
has been successfully tested in selected hospitals in Europe, the United States, and Southeast Asia.
Image: The NGAL rapid ELISA kit for detecting AKI (Photo courtesy of BioPorto Diagnostics).
Handheld Diagnostic Solutions Achieve Performance Requirements in POC Applications
n important milestone was achieved in the development of fully automated, handheld, rapid diagnostic test solutions for use at the point-of-care (POC). One important target application
for the technology is the measurement of cardiac Troponin-I levels in blood to assist in the rapid diagnosis of myocardial infarction. Troponin-I is typically found at elevated levels in patients who have suffered a heart
attack. However, it is only present in the patients blood in picomolar concentrations. In the past, detecting these extremely low concentrations has required costly time-consuming laboratory-based testing. The milestone was the result of the integration of bioMrieuxs (Marcy lEtoile, France; www.biomerieux. com) assay technology and Philips (Eindhoven, The Netherlands; www. philips.nl) Magnotech rapid diagnostic testing technology, into a disposable cartridge and handheld reader combination that achieves speed, sensitivity, and precision. The success represents one of the first POC multiassay solutions with the potential to achieve lab
quality performance. The achievement was realized within a year of the two companies signing a joint development agreement in January 2010 to develop handheld diagnostic solutions, and means that both companies will now go ahead with the development program. Philips will further develop its prototype handheld reader into a fully engineered, rugged unit, while bioMrieux will continue the assay development. In addition, Philips will set up manufacturing facilities to be ready to produce the disposable cartridges for the 2013 commercial launch of the new solution.
Body Fluids-Based Diagnostics to Be Developed and Validated

wo new agreements have been made for the development and validation of microRNA-based diagnostics for various indications. The Gen 3 tests will focus on cardiovascular indications, neurodegenerative diseases, womens health, and early detection of certain cancers, and are designed to leverage microRNA biomarkers extracted from body fluids. A leading developer and provider of microRNA-based molecular diagnostics, Rosetta Genomics (Rehovot, Israel; www.rosettagenomics.com) has entered into agreements with Tel Hashomer Medical Research Infrastructure and Services Ltd (Tel Aviv, Israel; http://eng.sheba.co.il) and Carmel Medical Center (Haifa, Israel; www.clalit.org.il/carmel).
The collaborations are an integral part of Rosetta Genomics Gen 3 product development process as they utilize the capabilities and samples at these specialized centers to identify initial microRNA candidate biomarkers for the companys discovery-stage projects. MicroRNAs (miRNAs) are small RNAs that act as master regulators of protein synthesis, and have been shown to be highly effective biomarkers. The unique advantage of microRNAs as biomarkers lies in their high tissue specificity, and their exceptional stability in the most routine preservation methods for biopsies, including Formalin Fixed Paraffin Embedded (FFPE) block tissue and fine needle aspirate (FNA) cell blocks.
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Automated Tests Differentiate Sexually Transmitted Infections

molecular test that detects and differentiates among the DNA of Herpes Simplex Virus (HSV) types is available for use with clinician-collected external anogenital lesions. The fully automated system, which uses Strand Displacement Amplification technology to identify the viral DNA qualitatively, will aid clinicians to diagnose symptomatic patients with HSV1 and HSV2. The ProbeTec HSV-1 and HSV-2 Qx Assays will significantly improve accuracy and time to results over culture methods, which often take 2-10 days for results. The new automated HSV assays will provide laboratories with the capability to read up to 96 positive or negative results in a little over two hours. When utilizing the Viper System with XTR Technology, clinical laboratories also will be able to run tests for Chlamydia and gonorrhea,
along with HSV-1 and HSV-2, on a single automated run. Both the ProbeTec assays and the Viper System are products of BD Diagnostics (Franklin Lakes, NJ, USA; www.bd.com). The ProbeTec assays have received US Food and Drug Administration (FDA, Silver Springs, MD, USA, www.fda.gov) 510(k) clearance for the first fully automated molecular tests to detect and differentiate HSV types 1 and 2 in external anogenital samples collected by the physicians. The assays are not FDA cleared for use with cerebrospinal fluid (CSF) or any lesions other than anogenital lesions. The assays are not intended to be used for prenatal screening or for individuals under the age of 17 years. Herpes virus infections are found worldwide,
and without seasonal variation. It is estimated that worldwide 314.8 million females and 220.7 million males, ages 15 to 49, were living with HSV-2 infection. The global number of new infections annually is estimated at 23.6 million.
Image: The ProbeTec Herpes Simplex Viruses Qx amplified assays (Photo courtesy of BD Diagnostics).
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Automated Cholesterol Test Showcased for Cardiologists

n expanded lipid profile assay performed on whole blood has been demonstrated to heart specialist at a conference using qualified attendees own samples. The blood test directly measures low-density lipoprotein (LDL) cholesterol (LDLc), without the patient having to fast, as well as 22 other cholesterol components. The Vertical Auto Profile (VAP) Cholesterol Test components include lipoprotein A, (Lp(a)), apolipoprotein B, (apoB), apolipoprotein A1, (ApoA1), and the apoB/apoA1 ratio, making the VAP Test the only lipid profile that routinely reports all three lipid parameters, LDL, non-high-density lipoprotein (HDL) and apoB. These three lipid parameters are considered essential diagnostic parameters by the American College of Cardiology (ACC, Washington DC, USA; www.cardiosource.org), and the American Diabetes Association (Alexandria, VA, USA; www.diabetes.org). The comprehensive lipid profile also identifies markers of metabolic syndrome, often associated with early diabetes. The VAP Cholesterol Test is produced by Atherotech Diagnostics Lab (Birmingham, AL, USA; www.atherotech.com), and provides clinicians with a single source for more than a dozen cardiovascular and metabolic tests. These include: high sensitivity C-reactive protein (hsCRP), lipoproteinassociated phospholipase A2 (LpPLA2), apolipoprotein E (apoE) genotype, the N-terminal prohormone of brain natriuretic peptide (NT-proBNP), cystatin C, triiodothyronine (T3) and thyroxine (T4) when the thyroid-stimulating hormone (TSH) is abnormal, and gamma-glutamyl transferase (GGT), a recognized cardiovascular risk biomarker. The VAP Cholesterol Test was exhibited to participants at the American College of Cardiologys 60th Annual Scientific Sessions held April 2-5, 2011, in New Orleans, LA, USA. Michael V. Mullen, president and chief executive officer of Atherotech, said, Atherotech invited ACC attendees to learn about our battery of cardiodiagnostic tests and learn firsthand the predictive power of the VAP Test.
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Automatic Blood Gas System Simplifies Blood Sampling and Data Capture
n automatic blood gas system simplifies blood sampling and data capture, from the initial ordering of blood gas tests through to receiving results at the point of patient care. The system offers faster testing and throughput, meaning that time previously spent in front of an analyzer is now available for direct patient care. The analyzer, called Radiometer (Brnshj, Denmark; www.radiometer.com) 1st Automatic, reduces errors, improving safety for patient and operator. The patient and sample IDs are scanned and linked together as the whole blood sample is drawn at the patients bedside, and the data is automatically sent to the analyzer, ensuring a correct patient-to-sample match throughout the test. The operator identifies the patient and then draws a blood gas sample using a one-hand device called a safe PICO sampler. The needle removal device allows optimal protection for the nurse. A safe tip cap is fitted onto the sampler,
which removes air bubbles when the plunger is pressed. Once the blood sample has been taken to the analyzer, it is automatically identified, mixed, and measured; the results are sent directly to a bedside monitor as well as the hospital information management system. Results are then transferred to patient records, and full documentation is available for regulatory requirement.
Image: The ABL80 FLEX, part of 1st Automatic, the worlds first automatic blood gas analysis system (Photo courtesy of Radiometer).
Genetic Biomarkers in Feces Predict Colon Cancer

iomarkers that predicted inflammation-associated colon cancer were found in mouse feces. This is the same type of cancer associated with some common human inflammatory bowel diseases such as ulcerative colitis and Crohns Disease. Scientists found that the bacterium that leads to inflammation-associated colon cancer in mice first results in inflammation that can be detected by screening feces for messenger RNA of genes. Craig Franklin, associate professor of veterinary pathobiology in the University of Missouri (MU) College of Veterinary Medicine (Columbia, MO, USA; www. cvm.missouri.edu), believes that this discovery could lead to tests for similar genes present in humans with early inflammation-associated colon cancer. The study was published in the December 2010 edition of the journal Neoplasia. The assumption was that the gene expression couldnt be detected in fecal matter because RNA breaks down very rapidly. Historically, this was something that a lot of scientists, including us, hadnt considered, Prof. Franklin said. But technology has evolved, and we now have the means of preserving RNA much better than we did 15 years ago. The new testing method should decrease the number of animals needed for research and could lead to a test for humans that will replace colonoscopies.
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Genetic Test Predicts Breast Cancer Relapse

gene signature has been discovered that can accurately predict which breast cancer patients are at risk of relapse, thereby sparing those who are not at risk from the burdens associated with unnecessary treatment. The test analyzes two sets of 29 genes from breast cancer-tumor samples. One set of genes is responsible for rampant neoplasia, which is the very fundamental nature of cancer, and the second set involves genetic instability. When the test results show high expressions of both sets of these genes, the patient would be at a high risk of a relapse. Scientists at McGill University (Montreal, QC, Canada; www.mcgill.ca) and their US colleagues, used a variety of molecular biology techniques to examine in 12 publicly available gene expression datasets comprising a total of 2,481 patients with breast cancer. The test is reported to be superior to an existing test, and has the potential to spare
women at a very low risk of relapse of breast cancer from undergoing toxic chemotherapy. Clinicians have been faced with the problem that breast cancer cannot be treated with a onesize-fits-all approach. Some cancers respond to specific treatments while others do not. Close to 50% of breast cancer patients belong to a group defined as estrogen receptor positive/lymph node negative (ER+/LR-), who are at low risk of relapse. The majority of patients in this group may not require any treatment beyond the surgical removal of their tumor, while a small minority should receive additional treatment. The study was published on February 1, 2011, in the Proceedings of the National Academy of Sciences of the United States of America (PNAS).
Image: Colored scanning electron micrograph (SEM) of breast cancer cells (Photo courtesy of Steve Gschmeissner / Science Photo Library).
Gene Expression Profile Linked to Liver Cancer
rotein expression levels revealed by immunohistochemistry and molecular methods have been reported from patients with hepatocellular carcinoma (HCC). The protein expression level of the transcription factor E2F5 can be estimated in formalin-fixed, paraffin-
embedded tissue blocks by microarray technology. This transcription factor is encoded by the gene E2F5, which is part of a family that plays a crucial role in the control of cell cycle and action of tumor suppressor proteins and is also a target of the transforming proteins of small DNA tumor viruses.
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Scientists at The Catholic University of Korea (Seoul; www.catholic. ac.kr), analyzed 120 tissue samples from primary HCC patients and 29 normal liver tissues by immunohistochemistry (IHC) analysis. The E2F5small interfering ribonucleic acid (RNA) was transfected into HepG2, an E2F5-overexpressed HCC cell line. They also explored the biological effects of E2F5 overexpression by knockdown of the gene and examined cell growth capacity and migrating potential. The investigators, using the tissue microarray-based IHC, found that E2F5 expression was mostly localized in the cytoplasm with occasional nuclear staining, and therefore cytoplasmic staining was considered a positive result.
They found that 18.3% of the patients with HCCs were positive, while none of the normal liver tissues was positive. The authors concluded that E2F5 is commonly overexpressed in primary human HCC and that E2F5 knockdown profoundly repressed the growth of HCC cells. The overexpression of E2F5 may induce uncontrollable cell cycle progression in liver cells and eventually contribute to cancer transformation by working together with other carcinogenic factors. This study will help to understand hepatocarcinogenesis mechanisms and to define therapeutic targets of early HCC. The study was published on January 28, 2011, in the World Journal of Gastroenterology
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Serum Biomarker Identified for Prostate Cancer

olecular methods have been used to identify micro ribonucleic acids (miRNAs) in serum, which can serve as biomarkers for prostate cancer. Noncoding miRNAs in the serum and plasma have been shown to have potential as noninvasive markers for physiological and pathological conditions including malignancy. Scientists at the University of California San Francisco (UCSF; San Francisco, CA, USA; www.ucsf.edu), have developed a multiplex quantitative reverse transcription polymerase chain reaction (qRT-PCR) method involving purification of multiplex PCR products followed by uniplex analysis to identify miRNAs. They used a microfluidics chip to evaluate 384 human miRNAs using small RNA deficient knockout mouse cells as the benchmark. The investigators confirmed the validity of their technique, while uncovering a significant lack of accuracy in previously published methods. The scientists profiled 48 sera from healthy men and untreated prostate cancer patients with differing Cancer of the Prostate Risk Assessment scores. They identified miRNA signatures that allowed them to diagnose cancer patients and correlate with prognosis. These serum signatures included oncogenic and tumor suppressive
miRNAs suggesting functional roles in prostate cancer progression. The uniplex analysis was performed on the microfluidics chip produced by Fluidigm Corporation (South San Francisco, CA, USA; www.fluidigm.com). The Fluidigm BioMark System transforms the way that scientists can perform high-throughput real-time quantitative PCR (qPCR) studies. The BioMark System uses microfluidic chips and features low input requirements providing the sensitivity and assay throughput necessary for qPCR. Fluidigms proprietary Integrated Fluidic Circuit technology enables single-cell discovery with the ability to screen hundreds of genes from single cells using standard TaqMan and DNA binding dye assays. The authors concluded that the modified qRTPCR demonstrated that primer carry-over from the multiplex PCR has detrimental effects on miRNA
quantification. This technique used on a nanoliter scale on a microfluidic chip allows for highthroughput multiplex qRT-PCR in a timely and cost-effective manner. The study was published on January 15, 2011, in Cancer Research.
Image: Confocal light micrograph of metastasizing prostate cancer cells (Photo courtesy of Nancy Kedersha / Science Photo Library).
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Test Aids in Identifying and Containing Norovirus Outbreaks

test for the most common cause of gastroenteritis will aid in identifying and containing Norovirus outbreaks. The Ridascreen Norovirus 3rd Generation enzyme immunoassay (EIA) is meant to be used when a number of people have simultaneously contracted gastroenteritis and there is a clear avenue for virus transmission, such as a shared location or food. The US Food and Drug Administration (FDA; Silver Springs, MD, USA; www.fda.gov) allowed marketing of this first test for the preliminary identification of Norovirus. The FDA reviewed data for Ridascreen via the de novo pathway, an alternative path to market for devices that are lower risk and may not require premarket approval (PMA), but are of a new type, and therefore may not be able to be cleared in a 510(k) premarket notification. This test provides an avenue for early identification of Norovirus, said Jeffrey Shuren, MD, JD, director of the FDAs Center for Devices and Radiological Health. Early intervention can halt the spread of an outbreak. Norovirus is a leading cause of food-borne disease outbreaks in the United States. Contamination usually occurs in settings where there is close group contact, such as cruise ships, hospitals, long-term care facilities, and schools or child-care centers. It is a highly contagious virus that spreads rapidly through direct person-to-person contact, contaminated food, or water, or by touching contaminated surfaces. The test is not sensitive enough for use when only a single person has symptoms and should not be used for diagnosing individual patients. Ridascreen is made by R-Biopharm AG (Darmstadt, Germany; www.r-biopharm.com).
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New Hepatitis B Sequencing Test Available in Europe

newly developed molecular diagnostic test identifies genomic sequences of Hepatitis B virus (HBV). Capable of identifying the DNA sequence of the HBV polymerase gene including all clinically relevant HBV drug resistant mutations, the test will help physicians monitor HBV infections, guide treatment decisions, and predict or reveal drug resistance. Abbott Molecular (Wiesbaden, Germany; www.abbottmolecular.com) received CE marking to market the HBV Sequencing test in the European Union. It is the first DNA sequencing assay developed and introduced by Abbott Molecular. The assay was developed for use on the Life Technologies (Carlsbad, CA, USA; www.lifetechnologies.com) ABI 3130 DNA sequencing system.
HBV is classified into eight separate genotypes (labeled A-H). HBV genotype is a prognostic indicator because it correlates with disease severity and response to interferon therapy. For example, patients with HBV genotypes A and B seem to respond better to interferon therapy than those with genotypes C and D. The test is not intended for screening blood donors, plasma or tissue donors for HBV, or to be used as a diagnostic test to confirm the presence of HBV infection. Abbott Molecular analyzes DNA, RNA, and proteins at the molecular level. Some of Abbott Moleculars tests are designed to detect subtle but key changes in human genes and chromosomes. The results of these tests may aid in the earlier
detection or diagnosis of disease, may influence the selection of appropriate therapies, and may improve monitoring of disease progression.
Image: The ABI 3130 DNA analyzer (Photo courtesy of Life Technologies).
Dipstick Assay Identifies Fungal Disease Antigen
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rapid point-of-care assay is under development that could lead to early diagnosis and potentially save the lives of people stricken with fungal meningitis. The assay detects cryptococcal antigen and will use a drop of blood from a finger-stick or a urine sample to identify immediately the presence of the disease so treatment can begin instantly, rather than having to wait for results to be processed at a laboratory. The Lateral Flow Assay is an immunochromatographic test system for the qualitative or semiquantitative detection of Cryptococcus species capsular polysaccharide antigens (CrAg) of both Cryptococcus neoformans and C. gattii in serum and cerebrospinal fluid (CSF). The test is the CrAg Lateral Flow Assay, which is a dipstick sandwich-immunochromatographic assay. Specimens and specimen diluent are added into an appropriate reservoir, such as a test tube, and the lateral flow device is placed into the reservoir. The test uses specimen wicking to capture gold-conjugated, anti-CrAg monoclonal antibodies and goldconjugated control antibodies deposited on the test membrane. The assay is being developed in a joint collaboration between scientists at the University of Nevada School of Medicine (Reno, NV, USA; www. medicine.nevada.edu) and Immuno-Mycologics, (IMMY; Norman, OK, USA; www.immy.com), who have licensed the CrAg Lateral Flow Assay. The assay has received the conformance marking (CE) of the European Community, and is being field tested in Africa. Thomas Kozel, PhD, professor of microbiology at the University of Nevada School of Medicine, said, The ability to quickly identify mycosis in patients is expected to help in significantly reducing cryptococcal meningitis deaths in resource-limited countries such as those in sub-Saharan Africa. Cryptococcosis is a rare form of meningitis among otherwise healthy individuals, but an estimated 600,000 lives are lost to this infection each year in patients with acquired immunodeficiency syndrome (AIDS). Many of these lives could be saved through early diagnosis.
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Multiplex Molecular Tests Detect Seven Intestinal Parasites

olymerase chain reaction (PCR) assays for intestinal parasites can be used on fecal DNA samples for enhanced detection of pathogenic organisms. A multiplex PCR-based assay for the ova and parasite stool examination is now available and the molecular technology is comparable with microscopy and copro-antigen detection systems. Scientists at the University of Virginia (Charlottesville, VA, USA; www.virginia.edu), adapted several existing real time PCR assays into a high throughput protocol for the major intestinal parasites. Fecal DNA specimens were obtained from 192 preschool-age or younger children from Bangladesh and 190 DNA specimens were obtained from the Leiden University Medical Center (Leiden, Netherlands; www.lumc.nl). Positive control materials were included in this study. The assay involves two multiplex PCR reactions, one with specific primers for the protozoa and one with specific primers for the helminths, after which PCR products are hybridized to beads
linked to internal oligonucleotide probes and detected on a Luminex platform (Luminex Corporation, Austin, TX, USA; www.luminexcorp.com). The Luminex protozoa assay showed a low limit of detection of 1,000 Giardia lamblia cysts, 100 Cryptosporidium parvum oocysts, and 10 Entamoeba histolytica trophozoites in 200 mg of a stool specimen. The Luminex helminth assay could detect Ancylostoma duodenale, Ascaris lumbricoides, Necator americanus, and Strongyloides stericoralis in very low concentrations. When compared with the parent multiplex real-time PCR assays, this multiplex PCR-bead assay afforded between 83% and 100% sensitivity and specificity on 319 clinical specimens. The authors concluded that the multiplex PCR-bead protocol provides an alternative high throughput molecular diagnostic platform for specific and sensitive detection of several major intes-
tinal parasites and is a potential alternative to microscopy for equipped laboratories. The study was published in February 2011, in the American Journal of Tropical Medicine and Hygiene.
Image: Colored scanning electron micrograph (SEM) of a Giardia lamblia protozoan, a single-celled parasite of the intestinal tract most common in tropical regions (Photo courtesy of Dr. Tony Brain / Science Photo Library).
Prognostic Biomarker Discovered for Aggressive Breast Cancer

novel cancer gene has been discovered that, when overactive, triggers a particularly aggressive type of breast cancer to develop. The oncogene was discovered using microarray technology, which allows large numbers of tissue samples to be tested simultaneously, picking up subtle differences in gene activity between normal cells and cancer cells. Scientists, based at the Cambridge Research Institute, (Cambridge, UK; www.cambridgecancer. org.uk), and at the British Columbia Cancer Agency (Vancouver, BC, Canada; www.bccancer.bc.ca), tested patients tumors to see if the gene, called zinc finger protein 703 (ZNF703), is overactive could help identify patients with more aggressive tumors, so their treatment can be tailored accordingly. They studied the patterns of gene activity in 1,172 breast tumors, as well as breast cancer cells grown in the
laboratory. This allowed them to eliminate one gene at a time until there was only one gene left within that region that was overactive in all the samples tested. It is thought that up to a third of more aggressive estrogen positive breast cancers could have multiple copies of the ZNF703 gene. In the study, there were two patients in which ZNF703 was the only gene shown to be overactive, which provided further evidence that it was the driving force in the development of the cancer. An important observation that arises from the data is that amplification of the genes ZNF703 and erythroblastic leukemia viral oncogene homolog 2,(ERBB2), which are almost completely mutually exclusive, jointly account for around two-thirds of all breast cancers of the Luminal B subtype. This has potential for
clinical application since a combination of immunohistochemistry and fluorescence in situ hybridization for these two genes/proteins (ZNF703 and ERBB2) can now be used to identify these more aggressive estrogen receptor positive (ER+) cancers in the clinic. Dr. Lesley Walker, director of cancer information at Cancer Research UK, said, This is the first gene of its kind to be discovered in breast cancer for five years. This is exciting because it is a prime candidate for the development of new breast cancer drugs designed specifically to target tumors in which this gene is overactive. Hopefully this will lead to more effective cancer treatments in the future. The study was published online on February 18, 2011, in the European Molecular Biology Organization (EMBO) Molecular Medicine.
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Cell Viability Tests Compared with Microchip Method

technique for the automatic cell viability measurement with a microscopic cell counter and microchip has been evaluated. An appraisal has been made of different methods of cell viability testing, an essential tool for performing cell-based studies and clinical laboratory tests. Scientists at Korea University Guro Hospital (Seoul, Korea; http://guro.kumc.or.kr) compared
Antibody Biomarkers Identified for Alzheimers

novel technique has been used in to discover antibody biomarkers that avoid the need for antigen identification in patients suffering from Alzheimers Disease. This new approach for the discovery of antibody biomarkers required no knowledge of the specificity of the immune response. An array of random synthetic molecules to pinpoint diseaseassociated antibodies was used instead of putative antigens. Scientists at the Scripps Research Institute (Jupiter, FL, USA; www.scripps.edu) used combinatorial library of unnatural, synthetic molecules that might serendipitously mimic the antibody-binding site of the primary antigen. The premise is that these synthetic molecules, termed peptoids, can form shapes that cannot be formed by unmodified biomolecules. Through mimicry, then, peptoids might be able to pinpoint antibodies that are important to the disease process and thus aid in the discovery of biomarkers. The team first used comparative screening of combination libraries of thee synthetic peptoids against serum samples from mice with multiple sclerosis (MS) like symptoms, as well as healthy mice. The peptoids that retained more immunoglobulin (IgG) from the blood samples of the sick animals were identified as potential agents for capturing diagnostically useful molecules. The team says this worked well. The investigators then examined serum samples from 18 humans, 6 with Alzheimers, 6 individuals with Parkinsons disease, and 6 healthy participants. They identified three peptoids that captured three times the IgG antibody levels in all the Alzheimers patients than the controls or Parkinsons patients. Two of the peptoids were found to bind the same IgG antibodies, while the third binds different antibodies, suggesting that there are at least two candidate biomarkers for Alzheimers. Thomas Kodadek, PhD, a professor at Scripps, said, The plan is to test the method now in the context of diseases, such as pancreatic cancer, where it is clear that early diagnosis could have significant implications for patient survival. It is possible that antibody-based tests might identify such cancers years before they could be detected otherwise. If those antibodies and the natural antigens that they recognize could be found using the new technology, it might even aid the development of new and more effective cancer vaccines designed to bolster the bodys natural defenses against the disease. The study was published in January 2011 in the journal Cell.
three different methods to test the viability of blood cells. Blood was drawn from 11 healthy volunteers and mononuclear cells were separated immediately from the heparinized whole blood, and the viable cells were diluted subsequently down from 100% to, 75%, 50%, 25%, and 1%. The cell viability tests were performed simultaneously with the following three methods: the conventional manual trypan blue exclusion method; the flow cytometry measurement with propidium iodide stain; and the newly developed automated fluorescence microscopic cell counter with microchip. The linearity, precision, and correlations from three methods were analyzed and compared. The correlations data from the microscopic cell counter were in good agreement with both the conventional trypan blue method and the flow cytometry. The precision and linearity from the microscopic cell counter method with microchip
were superior in comparison with the conventional method. The new microscopic cell counter with microchip, known as Adam (NanoenTek, Inc.; Seoul, Korea; www.nanoentek.com), was further developed and improved to produce the results within five minutes, including all procedural steps. In the manual trypan blue stain, only 200 cells were counted to measure their viability, but in Adam, larger number of cells, approximately between 1,000 and 3,000 cells, were counted. Greater number of counted cells and the repetitions of the experiments by the microscopic cell counter and microchip for the analyses provided the better statistical significance. The real-time cellular images and archived data could also be used for analyzing other parameters. The study was published online on March 15, 2011, in the Journal of Clinical Laboratory Analysis.
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PRODUCT NEWS
FLU A/B & RSV KIT

Focus Diagnostics
SAMPLE PREPARATION SYSTEM

Hitachi Aloka Medical
DIPSTICK IMMUNOASSAY
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The Simplexa kit real-time RT-PCR assay is designed for use on the 3M Integrated Cycler, a compact and portable platform that can provide results in 60 minutes after sample extraction. The kit aids in the detection of influenza A and B, as well as respiratory syncytial virus RNA.
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The LabFLEX 2500 features an automated opening system and dispensing system, to enhance efficacy while preventing contamination. Other benefits include a labeling system, a liquid volume monitor, and compatibility with standard five-tube racks.
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The QuickVue Dipstick Strep A test is designed for the rapid qualitative detection of Group A Strepococcal antigen from throat swab specimens. The 50-test kit features include high sensitivity at low levels of colony count, along with results available in five minutes or less.
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The two available replacement probes are designed for use on the Konelab analyzers, and are constructed of stainless steel and Teflon tubing. The cost-effective probes are available at less than half the cost of competitor probes, and carry a sixmonth manufacturer defect warranty.
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Tissue Microarrays Identify Biomarker for Prostate Cancer

mmunohistochemistry has been used to detect the expression of a biomarker for metastatic prostatic adenocarcinomas. Tissue microarrays made from cores were taken from the appropriate case specific paraffin-embedded tissue blocks were immunohistochemically stained for the protein biomarker claudin-3. A study performed at University of Pittsburgh School of Medicine, (Pittsburgh, PA, USA; www.medschool.pitt.edu), tested microarrays from 17 cases of benign prostatic hyperplasia (BPH), 35 with prostatic intraepithelial neoplasia (PIN), 53 patients with normal tissue adjacent to prostatic adenocarcinoma (NAC), 107 cases with primary prostatic adenocarcinoma (PCa), and 55
cases of metastatic prostatic adenocarcinoma (Mets). The tissue microarrays were stained with a rabbit polyclonal antibody anti-claudin-3 from Thermo Scientific, (Waltham, MA, USA; www.thermo.com). In the claudin-3 stained specimens, the average staining scores were highest in PCa and Mets. PIN had a lower absolute staining score than PCa and Mets, although the differences were not significant. Both BPH and NAC had significantly less staining than PCa and Mets. As claudin-3 is a tight junction protein, it is interesting to note that in addition to membranous staining, cytoplasmic staining was also seen in select cores, most prominently in cases of PCa and Mets.
The authors concluded that this study represents one of the first comparing the immunohistochemical profiles of claudin-3 in PCa and NAC to specimens of PIN, BPH, and Mets. These findings provide further evidence that claudin-3 may serve as an important biomarker for prostate cancer, both primary and metastatic, but does not provide evidence that claudin-3 can be used to predict risk of metastasis. Claudins are integral membrane proteins that are involved in forming cellular tight junctions, and claudin-3, has been shown to be overexpressed in breast, ovarian, and pancreatic cancer. The study was published on January 21, 2011, in Diagnostic Pathology.
Thirty-Two Products Developed for Immunophenotyping of Hematologic Malignancies
hirty-two new clinical flow cytometry reagents have been developed for immunophenotyping
of hematologic malignancies. A provider of reagents for multicolor flow
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cytometry has expanded its portfolio of antibodies, fluorochromes, and reagents for diagnostics, immunology, oncology, cell biology, and stem cell biology. eBioscience (San Diego, CA, USA; (www.ebioscience.com) manufactures the clinical reagents under The Good Manufacturing Practice (GMP) environment. The company assures good signal to noise and more than 90% purity. The Clinical Flow Cytometry Reagent product line was developed and optimized by eBioscience for the clinical laboratory user. The antibodies are packaged in flexible sizes to help manage precise budgets. All sizes are formulated at 5 L/test to ensure efficient multicolor immunophenotyping by reducing the ratio of reagent solution to sample volume critical for conserving precious samples. The wide selection of fluorochrome formats are needed for the variety of cytometers now found in clinical laboratories. The American Association for Cancer Research (AACR) 102nd Annual Meeting, (April 26, 2011) in Orlando (FL, USA) and the XXVI Congress of the International Society for Advancement of Cytometry (CYTO2011), May 2011 in Baltimore, (MD, USA) are showcasing eBiosciences expanding portfolio of clinical reagents.
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PRODUCT NEWS
MICROSCOPE ATTACHMENT
QBC Diagnostics
SED-RATE ANALYZER
Streck
CLINICAL ANALYZER
Toyko Boeki Medical System
BLOOD ANALYSIS SYSTEM

West Medica
The ParaLens Advance is designed to upgrade any compound light microscope for LED fluorescence microscopy. The ParaLens Advance features a powerful light source, and a removable filter set arm that allows users to quickly change between objectives whenever necessary.
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The ESR-Auto Plus 10-position automated analyzer is designed to accurately analyze the sedimentation rate of erythrocytes in 1.2 mL ESR-vacuum tubes. Key features include barcode scanner, patient result log, automated QC file, built-in printer, and results in 30 minutes.
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The Biolis 50i Superior is a fully automated, random access analyzer designed for clinical analysis. The system is the largest of the Biolis series, and features a throughput of 580 tests per hour with ISE, along with a wide range of functions for clinical labs.
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The Vision Hema automatic digital blood-smear analysis system is specially designed for hematologists. Key features include preparing and sorting blood-cell galleries, automatic choice of motion path, slide and analysis result database, and report generation.
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Capillary Electrophoresis-Based Assay Differentiates Respiratory Viruses

apillary electrophoresis can be used as detection platform in a multiplex assay for viral and bacterial respiratory pathogens. The multiplex polymerase chain reaction (PCR) assay has been compared to other PCR assays for the detection of Influenza A virus, Influenza B virus, and respiratory syncytial virus (RSV). In a study carried out at the Institute for Clinical and Experimental Pathology, (Salt Lake City, Utah, USA; www.path.utah.edu), scientists evaluated the capillary electrophoresis-based multiplex assay for three viral targets. Thirty respiratory samples were collected that had previously tested positive for a respiratory virus. There were ten samples from each of the following viruses: Influenza A virus,
Influenza B virus, and respiratory syncytial virus. The multiplex PCR test, called the Seeplex assay was manufactured by Seegene (Rockville, MD, USA; www.seegene.com). The assay detected nine of the ten influenza A samples; nine out of ten influenza B samples, and all ten RSV samples. The overall total detection rate was 93%. The two samples that were undetected by the Seegene assay both generated late-crossing thresholds on the realtime platform, consistent with low viral loads. The authors concluded that the Seeplex assay provides a promising alternative for multiplex respiratory testing. The importance of differentiating between respiratory pathogenic organisms is while those infected
with the 2009 H1N1 Flu strain, seasonal influenza A and B have similar symptoms, the correct antiviral drug must be prescribed for efficacious treatment. The 2009 H1N1 Flu, seasonal influenza A (H3N2), and seasonal influenza B viruses are susceptible to the neuraminidase inhibitors, while seasonal influenza A (H1N1) is resistant to these drugs. The Influenza B virus is easier to catch in fall/winter and symptoms are similar to those of Influenza A virus. Therefore, it is essential to differentiate between 2009 H1N1 Flu and other seasonal influenza viruses for administration of the appropriate therapy and prevention of drug resistance. The study was published in January 2011, in Annals of Clinical and Laboratory Science.
Mitomics Test Determines Presence of Prostate Cancer
test uses the science of mitochondrial DNA (mtDNA) to determine accurately the absence or presence of cancerous cells in prostate biopsy tissue. Called the Prostate Core Mitomic Test (PCMT),
it offers accurate, reliable results from existing prostate biopsy tissue. The PCMT can determine the presence of malignant cells via a cancerization field effect by detecting underlying molecular
alterations in normal appearing tissue. This is all performed quickly and easily with a simple lab test. Molecular changes are identified that enable detection of missed tumors; PCMT has demonstrated sensitivity of 84% and has also been shown to accurately rule out prostate cancer with a negative predictive value of 91%. Mitomics (Thunder Bay, Canada; www.mitomicsinc.com) is a company working on mitochondrial genome-based products to improve clinical insight and therapeutic decisions. It developed and launched the PCMT, which is available through the companys PCMT Clinical Laboratory Improvement Amendments (CLIA) laboratory in Aurora (CO, USA). With the high rate of false negatives, uncertainty associated with traditional diagnostic tools, whether biochemical or histopathology, and ongoing controversy regarding treatment paradigms, men at risk for prostate cancer are in need of new options, said Raoul Concepcion, MD, FACS, director of clinical research, Urology Associates P.C. in Nashville (TN, USA; www.urologynashville.com). The ability of PCMT to use mtDNA to potentially identify malignancy by detecting underlying molecular alterations in normal-appearing tissue is an important advance for managing patients whom the urologist feels may be at increased risk.
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PRODUCT NEWS
MICROPLATE/SLIDE PROCESSOR
A. Menarini Diagnostics
HEMOSTASIS ANALYZER
Analyticon Biotechnologies
AUTOMATED CHEMISTRY SYSTEM

Beckman Coulter
ASSAY SYSTEM
Boditech Med
The Zenit UP is an all-in-one solution designed for automation of ELISA and IFA methods. The accurate and reliable system offers a wide range of features, all allowing for an efficient and flexible workflow, that maximizes productivity and throughput.
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The Coagulyzer 100 is a compact, stand-alone lab solution designed with a focus on being user-friendly, reliable, and cost-effective. The easy-to-use analyzer is intended to meet the needs of low- to mid-volume hemostasis laboratories.
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The AU5800 series features enhanced speed to improve processing time, compared to current systems. The models are available in one- to four-module configurations, and are designed for high- and ultra-high-volume clinical labs.
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The i-CHROMA reader is a portable system designed to quantify single or multiple analytes simultaneously measuring the laser-induced epifluorescence of the test cartridge. The POCT system screens for a range of diseases, and provides results in as soon as three to 15 minutes.
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Breast Tumor Biomarker Tests Reveal Different Results

he tests for the Human Epidermal growth factor Receptor 2 (HER2) proteins and genes in tissue samples give equivocal results when more than one sample is tested. The reliability of immunohistochemistry tests for the HER2 protein and fluorescence in situ hybridization, or FISH tests for the HER2 gene have been studied since 2001 and their appears to be some variation in the overall results. Scientists from the Mayo Cancer Clinic Center, (Jackson, FL, USA; http://mayoresearch.mayo.edu) have studies whether teams of pathologists are in concordance when examining the results from these tests. Three teams of pathologists conducted a blinded review of samples from 389 patients who had
been enrolled in three adjuvant clinical trials in which HER2 testing was performed by local and central laboratories to determine if patients were candidates for these studies. Each of the three central laboratories received at least six slides from a patients tumor block that the laboratory used to retest HER2 gene and protein levels. The pathologists were from central laboratories at the Mayo Clinic, the University of Southern California, (Los Angeles, CA, USA; www.usc.edu), and the University of Pittsburgh, (Pittsburgh, PA, USA; www.pitt.edu). They found significant heterogeneity, or variability, between two tumor blocks taken from the same patient in 5% to 10% of cases. Most often, one tumor block showed a normal HER2
expression, while the second piece of tumor tested HER2 positive. They found that there was 92% agreement between the immunoassay and the FISH test. In 125 patients from the group of 389, who had more than one tumor block available for analysis they found that 5% to 10% of these samples had dissimilar protein and gene test results. Edith Perez, MD, deputy director of Mayo Clinic Cancer
Center, said, It is necessary for oncologists to continue to refine these tests and their analysis. That may mean some tests may be needed for multiple tumor blocks, or that pathologists may need to discuss borderline results for some patients. The findings were presented at the 33rd Annual San Antonio Breast Cancer Symposium held December 8-12, 2010, in San Antonio, TX, USA
Vitamin D Test Available for Use in EU

he new vitamin D assay is a fully automated immunoassay, which can help laboratories manage the expected increase in vitamin D testing volumes. The assay is intended for quantitative determination of 25-hydroxy (25-OH) vitamin D in human serum and plasma to aid in the assessment of vitamin D sufficiency. The 25-OH vitamin D test provides an accurate gauge of vitamin D status, and its measurement in patients provides opportunities for preventive and therapeutic interventions. The Abbott (Abbott Park IL, USA; www.abbott.com) diagnostic 25-OH vitamin D assay has received CE marking. The assay will measure levels of vitamin D in blood on the companys ARCHITECT automated instrument system. According to the International Osteoporosis Foundation, vitamin D deficiency is a global health issue. The percentage of the European population that is vitamin D insufficient is high, in some countries exceeding 75 %. Global demand for patient testing is estimated to be growing at 50
% per year due to increasing medical knowledge of the adverse health implications associated with vitamin D deficiency. Determination of the serum vitamin D concentration and supplementation according to the measured level is important for patients with osteoporosis, chronic kidney disease, abnormalities in absorbing food nutrients, and more generally, in those with a disease or a treatment that may impair bone health. As a major diagnostic lab, serum 25-OH vitamin D has become an increasingly important diagnostic marker to us, said Dr. Frans AL van der Horst, Reinier de Graaf Group, Diagnostic Center SSDZ (Delft, The Netherlands; www.rdgg.nl). There has been a great need for a reliable and cost effective assay. With the introduction of the Abbott test, we can fulfill these needs and significantly improve the efficiency of the workflow in our routine lab. The ARCHITECT 25-OH Vitamin D assay is not yet approved for use in the United States.
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LabMedica
Autonomous Biochip Leads to Rapid Diagnostic Capability
major milestone in microfluidics could soon lead to standalone, self-powered chips that can diagnose diseases within minutes. The novel biochip uses trenches patterned underneath microfluidic channels that are about the width of a human hair. When whole blood is dropped onto the chips inlets, the relatively heavy red and white blood cells settle down into the trenches, separating from the clear blood plasma. The Self-powered Integrated Microfluidic Blood Analysis System (SIMBAS) was developed by an international team, led by scientists at the University of California Berkeley (USA; www.berkeley.edu) and is able to process whole blood samples without the use of external tubing and extra components. The blood moves through the chip in a process called degas-driven flow, where air molecules inside the porous polymeric
device are removed by placing the device in a vacuum-sealed package. When the seal is broken, the device is brought to atmospheric conditions, and air molecules are reabsorbed into the device material. This generates a pressure difference, which drives the blood fluid flow in the chip. For the new SIMBAS biochip, the scientists took advantage of the laws of microscale physics to speed up processes that may take hours or days in a traditional laboratory. In experiments, they were able to capture more than 99% of the blood cells in the trenches and selectively separate plasma using this method. The team demonstrated the proof-ofconcept of SIMBAS by placing into the chips inlet a 5 L sample of whole blood that contained biotin at a concentration of about one part per 40 billion. The biodetectors in the SIMBAS chip provided the readout of the biotin levels in 10 minutes and the
limit of detection was 1.5 picomoles. Luke P. Lee, PhD, the principal investigator of the study, said, Field workers would be able to use this device to detect diseases such as human immunodeficiency virus (HIV) or tuberculosis in a matter of minutes. The fact that we reduced the complexity of the biochip and used plastic components makes it much easier to manufacture in high volume at low cost. The study was published online in March 17, 2011, in Lab on a Chip.
Image: The SIMBAS biochip (Photo courtesy of the University of California Berkeley).
Genetic Testing Should Be Conducted By Qualified Health Professionals

he unregulated growth of genetic tests marketed directly to consumers will have a significant adverse impact on consumers and undermine the physician-patient relationship. In many cases, it also represents the unauthorized practice of medicine. In a letter to the Food and Drug Administration (FDA; Rockville, MD, USA; www.fda.gov), the American Medical Association (AMA; Chicago, IL, USA; www.ama-assn.org) called for genetic testing to be conducted under the guidance of a physician, genetic counselor, or other genetics specialist. The letter was sent to the Molecular and Clinical Genetics Panel of the FDAs Medical Devices Advisory Committee regarding direct to consumer genetic tests prior to the panels hearings on the topic, scheduled for March 8-9, 2011. Direct to consumer (DTC) genetic tests may offer some benefits, such as promoting awareness of the genetic basis of disease and increasing attention to healthy behaviors that prevent the onset of
disease. However, the AMA is concerned about the potential of DTC genetic tests to cause harm to consumers and over time increase health care costs. Without the guidance of a physician, genetic counselor, or other genetics specialist, test results could be misinterpreted, risks miscalculated, and incorrect health and lifestyle changes pursued. At the very least, consumers will waste money purchasing tests with little value. Patients could make important reproductive decisions based on the results of carrier screening for hereditary diseases. These decisions require careful consideration of both the screening results and other factors, and it is essential that a physician or other genetics professional ensure that patients are well informed before making such decisions. Genetic tests often require a complete clinical context to be meaningful. A positive result does not necessarily indicate a clinical diagnosis;
instead, it may indicate an increased risk for developing a disease or condition, the phenotypic manifestations of which are variable in individuals. Conversely, since only a fraction of testable mutations are identified for genetically based diseases, a genetic test with a negative result is not indicative of the absence of disease risk. Without the benefit of proper medical counseling, patients may spend money on direct to consumer genetic tests needlessly or misinterpret the results of the tests, causing them to make unnecessary or unhealthy lifestyle changes, said AMA chair Ardis D. Hoven, MD. While genetic testing can be a valuable tool to aid in diagnostic and therapeutic decisions, it should be done under the guidance of a physician, genetic counselor, or other genetics specialist. These health professionals are best prepared to help patients understand the results and the limitations of the tests, and what type of action should occur based on the results.
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LabMedica
Automated Systems Detect Variant Hemoglobins

he detection performance of automated highpressure liquid chromatography (HPLC) systems for variant hemoglobins has been compared. The HPLC systems have become the method of choice for the evaluation of patients suspected with hemoglobinopathies, but they vary in their performance and ability to discriminate variant hemoglobins. Scientists at the University of California Davis Health System, (Sacramento, CA, USA; www.ucdmc.ucdavis.edu), evaluated the performance of two HPLC methods used in the detection of common hemoglobin (Hb) variants. They tested 377 samples, of which 99 were from patents with HbS, 32 with HbC, 78 with other hemoglobin variants or thalassemia, and 11 with increased hemoglobin A1c. The interpretations of each chromatograph produced by the HPLC systems were compared. The two systems were the Variant, (Bio-Rad Laboratories, Hercules, CA, USA; www.bio-rad.com), and the Ultra2, (Trinity Biotech, Kansas City, MO, USA; www.trinityusa.com). Both the Variant and Ultra2 methods use a relatively short program that measures the separation process over approximately 46 minutes. The Ultra2 has a secondary feature that will reflex repeat test samples with abnormal peaks or unusual findings using a highresolution method that observes the separation process over 6-8 minutes, allowing for better separation of the hemoglobin peaks. There were no differences noted for hemoglobins A0, S, or C. There were significant differences between the HPLC methods for hemoglobins F, A2, and A1c. However, there was good concordance between normal and abnormal interpretations (97.9% and 96.2%, respectively). The authors concluded that both the Variant and Ultra2 HPLC methods were able to detect most common hemoglobin variants. There was better discrimination for fast hemoglobins, between hemoglobins E and A2, and between hemoglobins S and F using the Ultra2 HPLC method. Hemoglobin variants are a result of genetic changes resulting in abnormal or dys-synchronous hemoglobin chain production, as in thalassemia or the generation of hemoglobin chain variants such as hemoglobin S, as seen in sickle cell anemia. Automated high-pressure liquid chromatography (HPLC) systems have become the method of choice for the evaluation of hemoglobinopathies. With this method, samples are mixed
with buffers and salts and injected through an ion exchange column where physical properties of the hemoglobin such as surface charge and hydrophilic group, are separated during migration. HPLC methods allow for better isolation of hemoglobin variants and are less subjective than electrophoretic methods. The study was published in the April 2011 edition of the International Journal of Laboratory Hematology.
Image: The Variant II Turbo hemoglobin testing system (Photo courtesy of Bio-Rad Laboratories).
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2011
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PRODUCT NEWS
CHEMISTRY ANALYZER
Caretium Medical Instruments
IMMUNOASSAY SYSTEM
Siemens Healthcare Diagnostics
SPECIMEN PROCESSOR
Copan Diagnostics
ARRAY TEST KIT

DiagCor Bioscience
The NB-201 semiautomated analyzer features a large LCD and touch screen, as well as seven filters and one free position. Other benefits include temperature control, a QC graph print out, programmability for 112 test profiles, and memory for 3,200 sample results.
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The IMMULITE 2000 XPi offers a large menu of automated tests, along with hardware and software solutions to enhance productivity and efficiency in medium- to highvolume labs. A user-friendly touch screen interface and remote monitoring add to the systems benefits.
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The WASP walk-away system is designed to manage all aspects of specimen processing, planting and streaking, gram slide preparation, and enrichment broth inoculation. The WASP streamlines operations, and offers a throughput equal to three full-time equivalent units.
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The GenoFlow DR-MTB is designed for the detection of wild-type MTB and drug-resistant MTB for management of active tuberculosis. The test is user-friendly, requires only four hours from DNA extraction to data interpretation, and allows 24 samples to run simultaneously.
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Genotyping Test Evaluated for HPV

genotyping test kit has been evaluated for identifying human papilloma virus (HPV) in histological tissue samples. A Linear Array HPV test kit identifies, and then specifically genotypes the virus in formalin-fixed, paraffinembedded (FFPE) tissues from head and neck cancer patients. In a study performed at Dartmouth Medical School, (Lebanon, NH, USA; http://dms.dartmouth. edu), scientists evaluated the performance of Roche Linear Array HPV Genotyping test kit assay (F. Hoffmann-La Roche AG, Basel, Switzerland; www.roche.ch), for accuracy, for intra-assay and interassay precision, and for its limit of detection, using materials with known HPV status. DNA from formalin-fixed, paraf-
fin-embedded tumor sections was isolated and amplified in duplicate, with positive and negative controls, using primers specific to the polymorphic L1 region of the HPV genome. Thirty-seven genotypes were tested using the linear array. The amplified product (450 base pairs) was visualized by gel electrophoresis and, if positive, reflexed to HPV genotyping. Of these cases, all were determined to have suitable DNA for genotyping based on an internal control gene reaction. The Linear Array HPV Genotyping kit contains positive -globin high-control and -globin low-control bands for determining whether the DNA from FFPE tissue is suitable for HPV genotyping using this assay. Nine of the 16 tumors analyzed were HPV positive.
The detected genotypes included HPV 6, 16, and 69. Head and neck tumors commonly arise from the squamous and respiratory mucosa that lines the nasal and oral cavity, sinuses, pharynx, and larynx. The rate of oropharyngeal cancers diagnosed among Americans younger than 50 years is increasing. Infection of the oropharynx and tonsils by the human papillomavirus (HPV) has been linked to preneopla-
sia and cancer. The Roche Linear Array HPV Genotyping test was found to be an easy-to-use method for determining HPV genotype in the routine analysis of formalin-fixed, paraffin-embedded tumors. According to the authors, this assay was robust and can be performed routinely in a clinical laboratory setting. The study was published in December 2010, in the Archives of Pathology & Laboratory Medicine.
Immunoassay for Biomarker Predicts Risk of Heart Failure

n enzyme-linked immunosorbent assay (ELISA) that measures galectin-3 in human plasma has been used to calculate the risk of heart failure (HF). This ELISA assay quantitatively measures the concentration of human galectin-3 levels in EDTA plasma. This assay has high sensitivity with a lower limit of detection of 1.13 ng/mL) and exhibits no cross-reactivity with collagens or other members of the galectin family. In a study carried out at the University Medical Center Groningen, (UMCG; Groningen, The Netherlands; www.umcg.nl), blood samples were available from 592 heart failure patients during their index admission. Samples were also collected just before discharge when patients were stabilized and there was a mean follow-up of 18 months. Galectin-3 was measured by the ELISA method developed by BG Medicine (Waltham, MA, USA; www.bg-medicine.com). Levels of cytokines vascular endothelial growth factor (VEGF), interleukin-6 (IL-6), Creactive protein (CRP), and transform-
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ing growth factor- 1 (TGF- 1) were measured in the same plasma samples using Search-Light Proteome Arrays (Aushon BioSystems, Billerica, MA, USA; www.aushon.com). The investigators reported that the inflammatory markers were positively correlated to galectin-3 levels and the study confirmed that galectin-3 is a strong and independent predictor of adverse outcomes. The prognostic value of the galectin-3 biomarker remained even after adjustment for established risk factors for poor outcomes in HF, including age, sex, brain natriuretic peptide, renal function, and diabetes mellitus. The predictive power of plasma galectin-3 appears to be predominantly strong in heart failure patients with preserved left ventricular ejection fraction, which nowadays comprise about half of all HF patients. Serial measurements of galectin-3 do not appear to add to the prognostic power of single measurements. The details of the study were published in January 2011, in the journal Annals of Medicine.
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LabMedica
Point-Of-Care HbA1c Analyzer Enhanced

point-of-care (POC) immunoassay analyzer for diabetes management provides enhanced operator management and connectivity capabilities to meet the growing demands in POC testing for improved compliance management and data capture into patient records. The DCA Vantage Analyzer ensures that all analyzers are running the same quality control regimen required by their institution and that only authorized operators are running the devices according to their specified access level. The operator management capability has been expanded to support up to 1,000 operators, each with their unique access level as defined by their supervisor. Another enhancement to the analyzer is the ability to display, print, and transmit the HbA1c reference ranges with the patient results, aiding in improved results interpretation. POC managers are demanding better connectivity between their POC analyzers and the associated healthcare organization so that test results can be automatically transmitted to the laboratory and hospital information systems, and eventually to the patients electronic medical record. Siemens Healthcare Diagnostics (Erlangen, Germany; www.medical. siemens.com) launched the DCA Vantage Analyzer with Version 3.0 software. It has the capacity to manage a larger number of operators while providing the required security access modes to prevent unauthorized use. In addition, the analyzer is one of the first hemoglobin A1c (HbA1c) POC analyzers in the industry to include the POCT1-A2 communication protocol. Use of this standard interface simplifies the connection to POC data management systems, enabling results to be automatically transmitted to the patient electronic medical record. We are focused on providing our customers with a trusted, clinically proven, point-of-care analyzer to better manage diabetes patients at the time of visit, said Dr. David Stein, CEO, POC
business unit, Siemens Healthcare Diagnostics. At the same time, we are continually looking at ways to enhance our products to meet the changing needs of our customers. These newly added features are important to point-of-care managers who are responsible for tests conducted at remote sites with multiple operators and devices in order to drive testing compliance.
Image: The DCA Vantage point-of-care immunoassay analyzer (Photo courtesy of Siemens Healthcare Diagnostics).
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PRODUCT NEWS
GLUCOSE MONITORING SYSTEM

DIALAB
SINGLE-CHANNEL PIPETTE
HTL Lab Solutions
URINALYSIS REAGENT STRIPS

Dirui Industrial
RANDOM ACCESS ANALYZER

DRG
The DiaCheck monitoring system features an enhanced plasma equivalent calibration, and requires only a minimal amount of capillary blood for processing. The blood glucose level is displayed only five seconds after applying the blood sample.
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The Labmate Soft combines traditional design with a thumb-friendly spring system and an improved volume setting push button for effortless daily pipetting. Each Labmate Soft is equipped with a dual adjustment to meet the preferences of all users.
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The H13-Cr strips offer high sensitivity and accurate results for in vitro diagnostics. The test strips are easyto-read for both visual and instrument reading, match the color chart for fast results, and are conveniently packaged 100 strips per bottle.
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The HYBRiD XL allows for the simultaneous measurement of immunoassays and clinical chemistry parameters in one sample. Efficiency features include results in 10 minutes and a throughput of 80 tests per hour.
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Asymptomatic Drug Resistant Staphylococcus Detected

ethicillin-resistant Staphylococcus aureus (MRSA) can be detected in asymptomatic patients in an emergency department (ED) setting. The prevalence of asymptomatic MRSA colonization in ED patients is poorly described, particularly in the absence of skin and soft tissue infection-related complaints. A study to assess the prevalence of nasal and extranasal staphylococcal colonization in ED patients was carried out at the Boston University School of Medicine (Boston, MA, USA; www.bumc.bu.edu). The scientists evaluated the risk factors, and characterized the strains by molecular techniques. They actively surveyed 400 patients presenting to the ED. Testing was conducted on anterior nares, oropharynx, palms, groin, perirectal area, wounds, and catheter insertion sites. Swabs taken from the various sites were cultured and any S. aureus, whether sensitive (MSSA) or resistant (MRSA) to methicillin, were characterized by a multiplex polymerase chain reaction assay. The prevalence of colonization with MSSA was 39%, and prevalence of colonization with MRSA was 5%. Among MRSA-colonized subjects, an extranasal site tested positive in 80% of subjects, and 45% had exclusive extranasal colonization. Human immunodeficiency virus (HIV) infection showed the strongest association with MRSA colonization, with a nearly 14-fold increased risk. Among factors at least tripling the risk was a history of diabetes, presenting from a nursing home, and playing contact sports. However, among those who were colonized, 20%
had no risk factors for colonization and 45% were colonized only at sites other than the nose. Of those colonized with MRSA, 55% were infected with the USA300 strain which often carries the Panton-Valentine leukocidin virulence factor and is responsible for invasive skin and soft tissue infections, necrotizing pneumonia, necrotizing fasciitis, and other serious infections in otherwise healthy hosts. Elissa M. Schechter-Perkins, MD, M.P.H., the lead author of the study, said, These findings suggest that current programs that screen for MRSA, which typically screen for nasal MRSA colonization among patients perceived to be at high-risk, may actually be missing a large number of patients actually colonized with MRSA. This has implications for spread of MRSA colonization and subsequent infections that nasal screening programs aim to prevent. The study was published online on January 15, 2011, in Annals of Emergency Medicine.
Image: Colored scanning electron micrograph (SEM) of Methicillin-resistant Staphylococcus aureus (MRSA) (Photo courtesy of Paul Gunning / Science Photo Library).
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LabMedica
Routine Screening Recommended for Sexually Transmitted Diseases

n improved and more sensitive test should be included in the screening of vaginal swabs for women suspected of having sexually transmitted diseases (STD). A molecular diagnostic assay that uses transcription-mediated amplification (TMA) for the detection of Trichomonas vaginalis augments the laboratory diagnosis of venereal diseases. Scientists at Rhode Island Hospital (Providence, RI, USA; www.rhodeislandhospital.org), compared a TMA assay with a direct-specimen, ribonucleic acid (RNA) probe-based diagnostic test designed to differentiate and identify pathogens associated with bacterial vaginosis (Gardnerella vaginalis) and vaginitis (T. vaginalis and Candida species). A total of 781 consecutive specimen pairs, consisting of one vaginal specimen and one cervical or urine specimen, were collected from 766 women from July 2009 to August 2010.
The study revealed that the APTIMA assay (Gen-Probe, San Diego, CA, USA; www.gen-probe.com) detected 36% more women infected with T. vaginalis, yielding a sensitivity of 100% and no false positives. The authors noted a high prevalence of trichomoniasis in women in the 36 to 45 year-old age group, who are not normally included in the recommended STD screening criteria. The AFFIRM Vaginitis three pathogens (VPIII) RNA assay, (BD; Franklin Lakes, NJ, USA; www.bd.com), which is commonly used in obstetrics and gynecological patients, produced one false positive and 15 false negative results in symptomatic patients. Trichomoniasis can affect both men and women and the true prevalence and clinical impact is unknown because current methods of detection exhibit poor sensitivity when compared to molecular amplification methods. Kimberle Chapin,
MD, lead author of the study, said, Despite a worldwide prevalence rate likely to be double that of gonorrhea or Chlamydia infections combined, trichomoniasis is not currently a reportable disease in the United States. We also found the disease was most prevalent in women ages 36 to 45 and in women ages 51 to 60. This was def-
initely surprising and a new finding in these age groups. The study was published in March 2011, in the Journal of Clinical Microbiology.
Image: Colored scanning electron micrograph (SEM) of the parasitic protozoan Trichomonas vaginalis, the cause of sexually transmitted vaginitis (Photo courtesy of Moredun Animal Health).
Integrated Chip System Developed as Complete Laboratory

device, based on chip technology, has been developed that will enable the diagnosis of eight or more different diseases on blood or cell samples. The integrated system based on microtechnology and biotechnology, will enable a number of conditions to be diagnosed automatically in the doctors own office. The chip looks like a credit card and contains a complete laboratory. The chip is engraved with a number of very narrow channels that contain chemicals and enzymes in the correct proportions for each individual analysis. When the patients sample has been drawn into the channels, these reagents are mixed. The card is then put into a machine than can read the biomarkers, such as DNA or enzymes, to produce a diagnosis. The project to develop the chip is being coordinated by SINTEF (Trondheim, Norway; www.sintef.no), the largest independent research organization in Scandinavia. Scientists at SINTEFs micro and nanotechnology laboratory have developed a number of techniques for interpreting the results when the biomarkers have been found. For
example, they can read them off in a spectrophotometer, an optical instrument in which the ribonucleic acid (RNA) molecules in different markers emit specific fluorescent signals. The project has used cells taken to diagnose cervical cancer as a case study, but in principle, the chip can check out a number of different diseases caused by bacteria or viruses, as well as various types of cancer. NorChip (Klokkarstua, Norway; www.norchip.com), the company that had the original idea, has just started a new two-year EU project that aims to industrialize the diagnostic chip to the mass-production stage while the company will also evaluate market potential and industrial partners. Frank Karlsen, PhD, the chief scientist at NorChip, said, The ways in which the chip can be used can be extended to enable patients themselves to take samples at home, and he expects that such special sampling systems will be ready for testing within a few years. The venture is part of the European Commissions (Brussels, Belgium; http://ec.europa.eu) project Microactive, which develops inoffice health test system.
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Antenatal Urine Samples Screened for Chlamydia

rine samples from pregnant women have been successfully screened to identify those infected with Chlamydia trachomatis. The urine screening was conducted using a commercial molecular assay utilizing target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) of C. trachomatis and Neisseria gonorrhoeae. Scientists at University of Texas Southwestern Medical Center, (Dallas, TX, USA; www.utsouth western.edu), tested a total of 2,018 pregnant women whose mean age was 26.9 years old, and of whom 84% were Hispanic. For four months, all women who were seen
at a group of family planning and obstetric complication clinics in the area and who were between 35 and 37 weeks pregnant were tested. Both urine samples and endocervical secretions were assayed. All samples were analyzed using the Aptima Combo 2 Assay, which is a target amplification nucleic acid probe test. The prevalence of Chlamydia according to tests of cervical secretions was 4.3% compared to 4.1% using urine sampling. The results from the two samplings were considered to be almost perfectly concordant. Sensitivity of urine screening was 96.5% relative to endocervical screening where the 95% confi-
dence interval (CI) was 90.1% to 99.3%, with a relative specificity of 100%. Urine screening for Chlamydia has shown to be accurate in male and nonpregnant female populations using Aptima Combo 2 Assay (GenProbe Inc.; San Diego, CA, USA; www.gen-probe.com). However, the scientists were uncertain that would translate to effectiveness in pregnant women. Their concern was that pregnant women might have amplification inhibitors not present in the nonpregnant population leading to nucleic acid amplification tests being less sensitive when performed on urine as compared with cervical specimens. However, this proved not to be the case. Scott W. Roberts, MD, lead author of the study, said, Removing the need for a speculum examination with its potential
benefits in costs and respect for patients desires has led us to use urine nucleic acid amplification testing for our C. trachomatis screening in all pregnant women. Urine sampling is also considerably cheaper than endocervical sampling, and scores points with patients who would rather not undergo an invasive exam. Chlamydia trachomatis is the most common bacterial sexually transmitted infection in the US. This disease disproportionately affects adolescent minority women, and untreated infection can lead to lasting reproductive tract morbidity. The study was published in the April 2011, edition of Obstetrics & Gynecology.
Image: Color enhanced scanning electron micrograph (SEM) of chlamydia (Photo courtesy of David M. Phillips / Science Photo Library).
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LabMedica
Blood Analyzer Goes Wireless
point-of-care hand-held analyzer allows real time transmission of diagnostic test results generated directly from the patient bedside. The handheld analyzer can potentially save precious time by allowing caregivers to perform critical tests at the bedside and then transmit test results immediately so they can be reviewed by physicians anywhere they have access to electronic records. The device, called the i-STAT 1 Wireless, eliminates the back-and-forth movement from the bedside to a desktop transmission terminal somewhere in the department giving staff the ability to focus on the patient better. For example, with the 10-minute i-STAT cardiac troponin test cartridge, emergency department staffs can test, transmit, and treat from the bedside. By sharing these test results via a hospitals existing wireless network, caregivers have rapid access to information that can help determine if a patient is having a heart attack. The i-STAT 1 Wireless is the latest version of the
device from Abbott Laboratories, (Abbott Park, IL, USA; www.abbott.com). Lightweight, portable, and easy to use, the i-STAT System features singleuse disposable cartridges that perform a broad menu of the most commonly performed diagnostic tests, including cardiac markers, blood gases, chemistries and electrolytes, lactate, coagulation, and hematology. Abbott announced it has received clearance from the US Food and Drug Administration (FDA; Silver Springs, MD, USA; www.fda.gov), to begin marketing the i-STAT 1 Wireless. The i-STAT System is used in nearly 2,000 hospitals and in nearly 1,000 emergency departments in the US. Some 50,000 i-STAT analyzers are used worldwide and they process about 100 million test cartridges a year.
Image: The i-STAT 1 wireless, point-of-care analyzer (Photo courtesy of Abbott Laboratories).
Agreement to Develop, Market Integrated Digital Pathology Solutions

oyal Philips Electronics (Eindhoven, The Netherlands; www.philips.com) and NEC Corporation (Tokyo, Japan; www.nec.com) have signed an agreement under which the two companies will jointly develop and market highly integrated digital pathology solutions. Initially targeted to assist in the grading of breast cancer and prostate cancer, the solutions will be based around Philips new high-throughput pathology slide scanner and NECs e-Pathologist Cancer Diagnosis Assistance System. They will be designed to use advanced digital techniques to add quantitative analysis to the qualitative information derived from the visual inspection of pathology slides, which is currently the standard procedure. When a lesion is suspected to be cancerous or precancerous, the normal procedure is to remove a sample of tissue from it and send it to a pathology lab for examination. A thin section of the tissue is mounted on a glass slide, stained to highlight various structures, and visually examined under a microscope. Philips ultra-fast slide scanner, which is already commercially available in Europe for research purposes only, employs a unique continuous autofocus technology that accurately follows height variations in the tissue surface over horizontal distances as short as 30 m, allowing extremely high definition full-slide images to be captured in less than one minute per slide. NECs e-Pathologist system will detect tissue and cell features within these images in order to identify regions of interest and make quantitative measurements of key structures in conventionally stained (hematoxylin and eosin) tissue samples, or samples stained with immunohistochemistry reagents. These quantitative measurements should assist pathologists in making decisions relating to the clinical treatment of cancer in individual patients. Philips and NEC aim to produce initial development results from their joint development in digital pathology within the current year.
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Molecular Technology Discriminates Between Cancer and Noncancer Patients

new molecular technology has been developed to detect distinct genetic changes differentiating cancer patients from healthy individuals and could serve as a future cancer-predisposition test. A DNA microarray has been designed that allows the measurement of the two million microsatellites found within the human genome using 300,000 probes and evaluation of global changes in the genome. This can determine whether pattern change alludes to a new mechanism disrupting the genome in cancer patients and may represent a new breast cancer-risk biomarker. Scientists from the Virginia Bioinformatics Institute (VBI) at Virginia Tech (Blacksburg, VA, USA; www.vbi.vt.edu), used a custom CGH-like oligonucleotide array to measure the global microsatellite content in the genomes of 72 cancer, cancer-free, and high risk patient and cell line samples and 56 germline DNA and 16 in tumor or tumor cell line DNA. They found a unique, reproducible, and statistically significant pattern of 18 motif-specific microsatellite families out of 962 possible 1-6 mer repeats in breast cancer patient germline and tumor DNA but not in germline DNA of cancer-free volunteer controls or in breast cancer (BRCA) patients with BRCA1/2 gene mutations. Microsatellites are short, repetitive DNA sequences that tend to vary greatly among individuals are used to uncover information related to a number of other genetic diseases such as FragileX or Huntingtons disease. Only a small percentage of microsatellites have been linked to cancer and other diseases because there has not been an effective method available for evaluating large numbers of these sequences. This technology is enabling scientists to understand the role of these understudied parts of the human genome for the first time and may help explain the difference between the known genetic components in disease and those that have been explained by genomic studies. This tool can be used to identify and better understand genetic changes in many different types of cancer with the potential to serve as a universal cancer biomarker. It has already been instrumental in the discovery of a new biomarker in the estrogen-related receptor gamma (ERR-) gene, which indicates an individuals increased risk for breast cancer. Harold Garner, PhD, a professor at VBI, said, We have now arrived at a new biomarker, an indicator that could be used to evaluate the amount of risk that you have for developing cancer in the future. The description of the technology allows us to very quickly and efficiently and inexpensively measure these two million places using a uniquely designed microarray. It is the pattern on that microarray that provides us the information we need. The study was published online on January 14, 2011 in Genes, Chromosomes, and Cancer
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LabMedica
Immunoassay Approved for Detecting Dengue Fever Virus

n enzyme-linked immunosorbent assay (ELISA) is now available to test blood samples for the presence of antibodies to the dengue virus. The ELISA test is designed for the qualitative detection of Immunoglobulin M (IgM) antibodies to dengue recombinant antigens (DENRA) in serum for the presumptive clinical laboratory diagnosis of dengue virus infection in patients with clinical symptoms consistent with dengue fever or dengue hemorrhagic fever. The complete kit includes one 96 well strippable plate with all necessary reagents and controls. The ELISA is easy to use and accurate and performance was thoroughly evaluated in prospective studies and with clinically confirmed cases of dengue 1-4 serotypes. It was developed with a new generation of US Centers of Disease Control and Prevention (CDC; Atlanta, GA, USA; www. cdc.gov), licensed recombinants expressed in mammalian cells. The accuracy was improved by monitoring background reactivity with Normal Cell Antigen and employs a simple, one-step ratio method of interpretation. Diagnostic testing for dengue is complicated by the fact that an IgM antibody response to the dengue virus infection is not detectable until 3-5 days after the onset of fever, which can produce a negative test result even though a person has dengue. During this IgM negative window, the dengue virus is present in the bloodstream. The DENV Detect IgM Capture ELISA test is based on technology patented by the CDC and manufactured by Inbios Inc, (Seattle, WA, USA; www.inbios.com). This new test shows cross-reaction with other closely related viruses such as those that cause West Nile disease. However, in most patient testing situations found in the US, a positive test result in a patient with signs or symptoms consistent with dengue should be considered presumptive evidence of dengue. This is the first in vitro assay for dengue, where the US Food and Drug Administration, (FDA; Silver Springs, MD, USA; www.fda.gov), reviewed data for the test via the de novo pathway, an alternative path to market for devices that are low to moderate risk and may not require premarket approval. Alberto Gutierrez, PhD,
director of the Office of In Vitro Diagnostics Device Evaluation and Safety in FDAs Center for Devices and Radiological Health, said, Cases of dengue fever or dengue hemorrhagic fever can be potentially fatal for people who do not recognize the symptoms. This test will now aid healthcare professionals in their effort to more effectively diagnose dengue.
Image: The DENV Detect IgM Capture ELISA test (Photo courtesy of Inbios).
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The Enzy Well line features liquid, ready-touse common reagents, breakable microwells, with cost-effective kit formats available.
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Rapid Diagnostic Tests Used as Source for Malaria DNA

alaria rapid diagnostic tests (RDTs) can be used as a resource for extracting malaria DNA for use with molecular confirmative technology. RDTs are frequently used as an adjunct to microscopy in the diagnosis of malaria and in settings where high quality microscopy is not available; the detection of Plasmodium infections is often based on RDTs alone. At present, there is no widely accepted way of assessing the quality of RDTs at the end-user level and both microscopy and real time polymerase chain reactions (RT-PCR) could be used as reference methods. Scientists at the Institute of Tropical Medicine (Antwerp, Belgium; www.itg.be) investigated the best method of extracting DNA from RDTs that would be used in a RT-PCR method. DNA extraction method was assessed on 12 different RDT brands and two RDT brands were comprehensively evaluated on a panel of clinical samples submitted for routine malaria diagnosis. The DNA amplification was done with the 18S ribosomal ribonucleic acid (rRNA) real-time PCR targeting the four malaria species. The results of the PCR from RDT samples were compared to those obtained by PCR on whole blood samples. The PCR on RDT DNA showed a detection limit of 0.02 asexual parasites/L, which was identical to the same PCR on whole blood. PCR analysis on clinical RDT samples demonstrated correct identification for single species infections for all RDT samples with asexual parasites
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of 60 Plasmodium falciparum samples and 10 samples each of P. vivax, P. ovale, and P. malariae. Samples with only gametocytes were detected in all OptiMAL Rapid Malaria Test (Diamed AG, Cressier, Switzerland; www. diamed.com), and in 10 of the 11 SDFK60 malaria Antigen Plasmodium falciparum/Pan tests (Standard Diagnostics Inc, Suwon, Korea; www. standardia.com). The authors concluded that in reference settings, PCR on RDT could be applied for confirmation of malaria infection when the whole blood sample is not available. Real-time PCR is of added value as it can distinguish between non-falciparum species and differentiate between single and mixed infections. Another application is post-travel quality control by PCR on for travelers returning home that used a RDT marketed for self-use during their travel. The study was published on March 24, 2011 in the Malaria Journal.
Image: Colored scanning electron micrograph (SEM) of a freeze-fractured red blood cell (erythrocyte, brown) infected with a Plasmodium falciparum protozoan (red) (Photo courtesy of the NIBSC).
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LabMedica
Leukocyte Biomarker Applied to Early Detection of Colon Cancer

enetic material extracted from white blood cells can be used as biomarkers for the early detection of colon cancer. The white blood cells, the monocytes, contain genetic material that when analyzed by a novel method, will enhance the monitoring of the development of the colon cancer in patients. White blood cells play a significant role in the growth of tumors, the metastasis of cancer cells and the formation of blood vessels in and around tumors. In addition, they serve a crucial function in combating malignant cells. They form the core of the defense mechanism, which the body musters against cancer cells. The scientists will link changes in the genetic material of monocytes to the presence and progression of colon cancer. The advantage of this approach is that monocytes are easy to extract from the patients blood sample. Massimiliano Mazzone, PhD, who heads a laboratory at the Katholieke Universiteit Leuven (Leuven, Belgium; www.kuleuven.be), has just been awarded a substantial grant over a three year period to refine the technique. He has specialized in blood vessel formation in tumors. His most important discovery is the phalanx cells, highly streamlined cells on the inside of blood vessels that are needed for improved supply of oxygen. These more quiescent endothelial cell types in nongrowing vessels survive for many years and maintain lumen patency. These cells form a tightly aligned, orderly shaped, smooth layer with a typical cobblestone appearance, comparable to the phalanx formation of Greek Spartan soldiers. The grant was awarded by The
Fournier-Majoie Foundation for Innovation (FFMI; Brussels, Belgium; www. ffmi.eu). In close collaboration with oncology specialists at the University Hospital of Leuven (Leuven, Belgium; www.uzleuven.be), the grant recipients hope to go from the bench to the bedside in a very short time.
Image: Immunofluorescent light micrograph of human colon cancer cells (Photo courtesy of Nancy Kedersha / Science Photo Library).
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Systems Array Developed to Detect Minute Amounts of Proteins

capillary electrophoresis system has been used to identify and characterize different proteins. The system uses capillary isoelectric focusing (cIEF) with laserinduced fluorescence detection. The apparatus has been set up as a multiplexed array and has proved to be well suited to high-throughput analysis. The multiplexed capillary electrophoresis system employs an array of 32 capillaries with a micromachined sheath-flow cuvette as the detection chamber. The sample streams were simultaneously excited with a 473-nm laser beam, and the fluorescence emission was imaged on a charge-coupled device (CCD) camera with a pair of doublet achromat lens.
The performance of the technology was excellent as it provided the highest throughput isoelectric focusing analysis ever reported. There was a very high sensitivity for a high-throughput instrument, and excellent resolution separation for capillary isoelectric focusing. The capillary array electrophoresis system produced over six orders of magnitude superior detection limits compared to other systems. The technology will find wide application, including characterization of recombinant and therapeutic proteins, the diagnosis of disease, and the study of systems biology. Oluwatosin O. Dada, PhD, lead author of the study and a research assistant professor at the University
of Notre Dame, (South Bend, IN, USA; www.nd.edu) was awarded a prize for the best paper published in 2010 in Analytical and Bioanalytical Chemistry, (ABC). The editor of the journal, Prof. Aldo Roda, PhD, said, There is a highly competitive effort underway in the scientific community to improve the analytical performance of isoelectric focusing (IEF) as a
tool for protein separation and concentration. Several groups have investigated the miniaturization of cIEF and the integration of cIEF to a microchip format. This new analytical approach may resolve the ongoing problem of time-consuming procedures. The paper was originally published on line in ABC on March 25, 2010.
Coagulation Properties of Fresh Blood Lasts Longer Than Assumed

he blood clotting properties of refrigerated whole blood may have a shelf life well beyond the current standard of 24 to 48 hours. The majority of patients receiving blood transfusions only require specific components of whole blood, such as red blood cells, plasma and platelets and the coagulation properties are thought to decline rapidly. A study carried out at The Childrens Hospital of Philadelphia, (Philadelphia, PA, USA; www. chop.edu), examined the freshness of whole blood with respect to its clotting properties in 21 units of blood from healthy volunteer donors. The units of blood were stored under standard conditions as mandated by the American Association of Blood Banks, (AABB; Bethesda, MD, USA; www.aabb. org). Samples were obtained on the day after donation and again on days 2, 4, 7, 11, 14, 17, 21, 24, and 31. Tests included complete blood count, pH, partial pressures of oxygen and carbon dioxide (pO2, pCO2), glucose, lactate, thromboelastography (TEG), and platelet func-
tion by light transmission aggregometry (LTA). The current practice at The Childrens Hospital of Philadelphia assumes a fresh whole blood shelf life of 48 hours when refrigerated. After that point, the erythrocytes may be recovered from the whole blood, but the other components, such as plasma and platelets must be discarded. However, the scientists found that TEG and platelet aggregation levels, which measure the efficiency of blood coagulation, remain normal at least 11 days under standard refrigerated conditions. David Jobes, MD, a cardiothoracic anesthesiologist at the hospital, said, Trauma patients could potentially benefit, as well as others needing a large volume of blood replacement, such as patients undergoing liver transplant or children who need craniofacial reconstruction. The results of the study strongly suggest that clinical trials should proceed to test the value of whole blood beyond a 48-hour period. The study was published in January 2011, in the journal Transfusion.
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Edited by Edgard Delvin, Ph.D., FCACB

IFCC members may send news to: Edgard Delvin, Ph.D., FCACB, Head, Dept of Clin Biochemistry, CHU Ste-Justine, 3175 Cote Ste-Catherine, Montreal, Quebec H3T1C5 Tel: (1) 514-345-4831 (ext. 5635); E-mail: edgard.delvin@recherche-ste-justine.qc.ca
NEWS
Dr. Graham Beastall, President, IFCC
In Berlin, in the Spirit of Friendship and Global Identity

Paris Chosen for EuroMedLab 2015
by Dr. Bernard Gouget
IFCC Executive Board Member and Treasurer-Elect 2012-2014 Secretary General, International Francophone Federation of Clinical Biology and Laboratory Medicine (FIFBCML)
he 21st International Congress of Clinical Chemistry and Laboratory Medicine (CCLM) and 19th IFCC-EFCC congress of CCLM in Berlin have just ended. The congress marked a great success with over 4500 delegates and speakers from more than 100 countries, with over 12 plenary lectures in 4 sessions, 22 symposia, interactive sessions, 14 workshops, and more than 40 industry sponsored workshops. Total attendance was over 8500 people. This four-day academic program provided the participants opportunities to communicate, to exchange ideas, and to make friends. We remember how many conference rooms were still packed during the last minute of the congress. The organizers built on the previous experience and implemented innovations positively received for the most part as were the poster walk, the Year in Review sessions and though overcrowded at times--the high number of young scientists and the involvement of the leading journals. This IFCC/EFCC congress acted as a permanent platform for framing future considerations of global laboratory medicine developments and health challenges promoting the translation of research progress from the laboratory to the beside and to populations. It is the IFCC/EFCC vision to harness academic excellence to improve health. In addition to science, it was possible to enjoy Berlin as a modern metropolis strategically placed at the crossroads where East meets West in the heart of Europe. Berlin has undergone more changes than other European capital and is still changing today. Berlin has offered to the IFCC/EFCC delegates a rich, diverse, and lively cultural environment with outstanding architecture with the Reichstag by Sir Norman Foster, the allnew Potsdamer platz featuring buildings by famous architects such as Renzo Piano, Arata Isozaki, and others. Thank you to Harald, Rudy, Karl, the German organizers, and the Emmezeta team that also gave us the exclusive opportunity to visit the Museum island, a UNESCO World heritage site, to meet the queen Nefertiti at the new museum and to enjoy the buffet at the colonnades. The Berlin meeting was one of the worlds foremost gatherings of leaders from academia, public and private sectors, in vitro diagnostic industry, stakeholders, civil society to jointly develop strategies and act to address key challenges in lab medicine practices and research with the aim to develop answers to lab medicine challenges. The 21st IFCC/EFCC Euromedlab will take place in Paris in 2015. The theme is Revolution in Laboratory Medicine, linking scientific and other evidence to shape tomorrows development in the field of Laboratory medicine and global health. It is a big challenge to organize such a sustainable high level and dynamic forum after Berlin 2011 and Milan 2013; on behalf the French society, we sincerely hope you could participate and contribute your invaluable experience and knowledge to organize this important IFCC/EFCC congress. By close collaboration between leading representatives in lab medicine from, research; health related industry and technology sector, international institutions, governmental and non-governmental institutions in analyzing todays science and by extensively sharing experience and debate, we will be able to structure tomorrows laboratory medicine.
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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
mote changes in laboratory parameters. Thus, the use of tourniquet has the potential to generate false positive results and prospectively induce the caring physicians to adopt undue treatments. On the other hand, transillumination is able to eliminate or greatly reduce these risks on hematological, biochemistry and coagulation laboratory tests. The use of transillumination device is based on cold near-infrared light-emitting diodes (LEDs) whose light is absorbed by intraerythrocyte hemoglobin flowing along the veins. In the course of my PhD program, I am presently dealing with the preanalytical issues both at Verona University (Italy) and at Federal University of Parana (Brazil). The working group, which consists of Prof. Gian Cesare Guidi and Prof. Giuseppe Lippi, Prof. Martina Montagnana and Dr. Gian Luca Salvagno, is helping me to identify the new source of errors to guarantee the patient safety. I am very lucky because I am a young scientist and this very important working group has opened doors to me. With this working group, I learn, work, and help improve patient safety. If Labs are vital then young scientist are essential to study sources of laboratory errors both to guarantee patient safety and to improve the future of laboratory medicine.
The Future of Laboratory Medicine:
Researchers Look for New Possible Sources of Error in Order to Guarantee Patient Safety
by Gabriel Lima-Oliveira Brazilian Society of Clinical Analyses in Sao Paulo State, Brazil & MERCOSUL: Sector Committee of Clinical Analyses and in Vitro Diagnostics
owadays important organization like World Health Organization - WHO and International Federation of Clinical Chemistry and Laboratory Medicine - IFFC are intensively working to decrease laboratory error thus guaranteeing patient safety. Many laboratory professionals think that to eliminate laboratory error is enough to make internal quality controls and proficiency tests. The problem is that most frequently errors in laboratory occur in extra-analytical phases (i.e., pre- and post-analytical). Moreover, there are only few routine procedures for the detection of nonconformities in this field of activity. In the preanalytical phase, the procedures involving phlebotomy, critical to obtaining of diagnostic blood specimens, are poorly studied as regards the major sources of errors and the proce-
dures related to the quality control process. Personally, I did study during my master's degree the impact of tourniquet application time during diagnostic blood specimen collection and was able to find a new way to eliminate this problem by transillumination. From a practical point of view, the tourniquetinduced venous stasis promotes the exit of water, diffusible ions, and low molecular weight substances from the vessel thereby increasing the concentration of various blood analytes at the punctured site thus potentially influencing the interpretation of laboratory results. More so, when the vascular microenvironment is subjected to both hypoxia and concurrent stasis, accumulation of some bioproducts ensues such as the protons that have the potential to pro-
Elections in Berlin
New IFCC and EFCC Executive Boards Elected
At the General Assembly held on Sunday May 15, the new EFCC Executive board was elected for the term July 1, 2011- 2013. It is as follows: President: Dr. Ian WATSON (United Kingdom); Past President: Prof. Andrea Rita Horvath (Hungary); President-Elect: Prof. Mauro Panteghini (Italy); Secretary: Dr. AnaMaria Simundic (Croatia); Treasurer: Prof. Dr. Peter Schuff-Werner (Germany); Members-At-Large: Dr. Huib Storm (The Netherlands), Prof. Tomas Zima (Czech Republic). At the Council Meeting held recently in Berlin the IFCC Executive Board was elected to serve for the period January 1, 2012, to December 31, 2014. It is as follows: President: Graham Beastall (UK); Past President: Jocelyn Hicks (US); Vice President: Howard Morris (AU); Secretary: Sergio Bernardini (IT); Treasurer: Bernard Gouget (FR); Member: Vanessa Steenkamp (ZA); Member: Larry Kricka (US); Member: Ulisses Tuma (BR); Corporate Member: Thomas Brinkmann (Unilabs).
News from the Corporate Members:
New Layout for Lab Tests Online Entry Point
russels, 5 May 2011 EDMA is proud to announce that www.labtestsonline.info is now online with a new layout. Aiming at providing a better entry point for patients looking for accurate information on laboratory testing, the new page emphasizes the international scale of the project (14 countries worldwide, 10 of which in continental Europe coordinated by EDMA). Lab Tests Online offers a clear and easy way to understand information to citizens and physicians about the diverse and advantageous contributions of laboratory medicine to health protection and care. Thus, users can inform themselves about the tests they have been prescribed, the conditions usually related to the assays, and how the success of the treatment is evaluated. To get a better understanding of the project please visit: www.LabTestsOnline.info where you can access all national sites. For more information, please visit the EDMA website or contact: Daniele Dosi, EDMA Communications Officer (Tel. +32 2 777 02 78).
Clinical Chemistry Trainee Council: A New Initiative
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uring the IFCC WorldLab-EuroMedLab meeting in Berlin, the journal Clinical Chemistry launched a new initiative entitled Clinical Chemistry Trainee Council. This initiative is an extension of the educational program of the journal that is meant to reach trainees in clinical chemistry and laboratory medicine throughout the world. The journal currently publishes a variety of educational materials including Clinical Case Studies, Q&A (a virtual roundtable discussion among a group of experts about a hot topic), and the Guide to Scientific Writing (a series of 14 articles). In addition, the journal periodically publishes interviews with world scientific leaders and articles about prominent clinical chemists (Inspiring Minds) that can be of great interest and serve as an inspiration to young scientists. Through the Council, the journal will make these materials available to trainees free of charge. The materials can be accessed via a special website that has been specifically designed for this purpose. The website will also enable the journal to provide the trainees with Webcasts (lectures by leading international scientists), Pearls of Laboratory Medicine (10-15 minute presentations about a laboratory test), and Council Chat (a chat room directed by 6 junior faculty members from around the world). In addition, the trainees will have access to our more than 70 popular podcasts, which have been downloaded over 230,000 times in the last 2 years. To access the website go to www.traineecouncil.org The recently launched English version of this program targeted over 7,000 MD/PhD trainees and future leaders in clinical chemistry and laboratory medicine in 25 countries. In November of 2011, this initiative will be launched in Spanish during COLABIOCLI in the Dominican Republic, and in 2012 in Russian, Arabic, and Chinese. In the near future, we hope to produce a Portuguese version of the program.
by Nader Rifai, Editor in Chief, Clinical Chemistry
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A Quality Meeting in Mexico City: CSCC Links with Latin America

by Dr. David M Parry, Department of Clinical Biochemistry, St-Boniface hospital, Manitoba, Canada
he first International Meeting on Quality in Clinical Laboratories was held in Mexico City in November 2010. This meeting, organized by the National University of Mexico (UNAM) and the Program for the Quality of Clinical Laboratories (PACAL), gathered lab professionals to present and discuss experiences in establishing and maintaining quality in clinical laboratories. I was pleased to represent the CSCC at the invitation of Dr. Andres Romero Rojos, Head of the University Diagnostic Center. The conference was held in the lovely Centro Cultural Universitario Tlatelolco. To my delight, this building was built immediately adjacent to an expanse of Aztec ruins, which could be viewed from an overlooking balcony. This was the site of the last stand of the Aztecs in the war against their Spanish conquistadors in the 1500s. While this was fascinating for a first timer like me, it seemed to attract little attention from others attending the conference, presumably since it was simply part of everyday life in Mexico City. The meeting started with an assembly of some 800 participants. The speakers were paraded in to welcoming applause. There were eight of us from countries outside of Mexico, representing Canada, Chile, Cuba, El Salvador, Spain, USA, and Venezuela. As the proceedings were in Spanish, I was always unsure what to expect next. After a few speeches, award presentations to honored individuals and speaker introductions, a video was presented featuring Pacalito, a Mayan God as protagonist (this video can be viewed on YouTube pacalito 2.mp4). While the significance of this animated God escapes me, it was clear from audience reaction that he represents an important symbol to the laboratory community in Latin America. After opening ceremonies, participants scattered throughout the center and speakers were ushered to different presentation rooms. Vincent Gallicchio from South Carolina and me were the only ones who gave presentations in English (with simultaneous translation into Spanish). We each gave two presentations, the titles of which are shown below to give you a sense of overall content. Promotion of Laboratory Best Practices World-Wide: Focus on Publications and Educational Programs; and Improving Quality in Laboratory Medicine by Vincent Gallichio. Our Experience with Using an External Quality Assessment Program for Monitoring and Improving Quality; and Exploring Use of Standardized Control Charts and Procedures in a Canadian Lab by David Parry. Our presentations spanned the entire day and after each talk and questions, a half hour session was devoted to hand-
ing out awards to individuals who had successfully completed some earlier training. Hence, following my talks, my role changed cont on page 60
Photo: Dr. David Parry and his Mexican hosts Armando Esparza, Alfredo Aranda and Andres Rojos posing with Pacalito
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ogy), the other two specialties of health sciences directly related with the clinical laboratory, are classified as medical specialties. As the above classification is more or less the same in many countries around the world, when talking or writing internationally (not for a specific country), it would be respectful to the clinical laboratory professional community to avoid the nouns or adjectives biology/biological, chemistry/chemical, medicine/medical, and pharmacy/pharmaceutical in the classification of the different specialties of the clinical laboratory sciences.
References
1. International Organization for Standardization. Medical laboratories - particular requirements for quality and competence. ISO 15189:2007. Geneva: ISO; 2007. 2. Gobierno de Espaa. Real Decreto 183/2008, de 8 de febrero, por el que se determinan y clasifican las especialidades en Ciencias de la Salud y se desarrollan determinados aspectos del sistema de formacin sanitaria especializada. Boletn Oficial del Estado 200802-21;(45):10020-35. 3. European Parliament, Council of European Union. Council Directive 93/16/EEC of 5 April 1993 to facilitate the free movement of doctors and the mutual recognition of their diplomas, certificates and other evidence of formal qualifications. EurLex Access to the Uropean Union law.
Spanish Royal Decree: Classification of Health Sciences Specialties

by Xavier Fuentes-Arderiu, ACCLC past-president, IFCC News Working Group
he standard ISO 151891, conceived to be applicable world-wide, states more or less explicitly that the clinical laboratory is a laboratory where examinations related to biology, microbiology, immunology, chemistry, immunohematology, hematology, biophysics, cytology, pathology, or other, are done in materials derived from the human body for purposes related to healthcare. One issue is scientific approach to a fact, and the other is the political or corporate approach to the same fact. From an epistemological point of view, there are two main sets of knowledge obtained by applying the scientific method: science and technology (technique, according some authors). Science and technology may be considered as the trunk of a tree that grows by means of the scientific method; and all the scientific and technological disciplines (academic view) or specialties (professional view) are branches, more or less distant of the trunk, of this unique tree. Defining the relations between branches developed by different ways is not a trivial issue. Thus, in many countries there is a controversy about the classification of the above disciplines or specialties. Recently, the Spanish Government has answered and clarified the old question: is, for example, clinical (bio) chemistry a medical specialty, or it is an
independent specialty of health sciences, as pharmacy, dentistry, or nursing are (in Spain as well as in other countries in the world)? Obviously, the same question applies for the rest of specialties forming the clinical laboratory sciences. This response has been made by means a Royal Decree (an Order in Council)2. The aim of this Order, among other issues, is to establish and classify the specialties in the broad field of health sciences. The Order divides the specialties of health sciences in five groups: Medical specialties, Multidisciplinary specialties, Nursing specialties, Pharmacy specialties, Psychology specialties. Regarding those specialties that may be considered related with the clinical laboratory, the Order classifies the following specialties of health sciences as multidisciplinary specialties [The neutral English nomenclature used in the European Parliament3 is followed by the literary word-by-word translation of the Spanish terms]: Clinical Biology (Clinical Analyses) Biological Chemistry (Clinical Biochemistry) Immunology (Immunology) Microbiology-Bacteriology (Microbiology and Parasitology) Pathological Anatomy (Anatomic Pathology) and Hematology-Hemotherapy (in part Biological Hematol-
A Quality Meeting in Mexico City: CSCC Links with Latin America

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to handing out Quality Tree Statues to recipients. There were many dozens of these awards handed out over the course of the day and these interludes were a pleasant break between talks. While our talks were translated into Spanish, our presentation slides were, of course, in English. Based on questions from the audience however, it was apparent that our messages reached receptive ears. After one of my talks, I
cool evening air, I learned about the complex history of Mexican independence and revolution. Traffic was mindboggling: it never seemed to let up. We had a very enjoyable evening dinner and shared stories about our different worlds of work and play. Perhaps the tequilas and enticing Mexican food platters we also shared helped liven it up a little. I found this to be the highlight of my trip, since it gave me a glimpse into what life in Mexico was really like.
Photo: Dr. David Parry helping handing out awards.
was besieged by a group seeking more information about Canadian laboratory practices. Most of their queries though, were not in English and communication required the help of a translator. My hosts, Alfredo and Armando made sure I was well fed, and already started talking about organizing their next conference in a couple of years. They were definitely pleased with the outcome of this conference and I assured them the CSCC would be pleased to participate in future events like this one. I can honestly say this conference was very well organized and attended and judging from the hustle and bustle of participants, it was an exciting event. I was hoping to learn more about what was happening in laboratories in Mexico by attending other presentations, but the opportunity for this was minimal. My time there was limited and my hosts were intent on assuring my visit was full. During a tour of Mexico City on a double-decker bus, open to the
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On the next day, I was taken to where there was a fascinating street display of huge papier-mch sculptures, hundreds of them lining both sides of the boulevard. These were created by artists in celebration of 200 years of independence and 100 years since revolution. After a heartfelt goodbye at the airport, I left Mexico, content with my contribution to the conference, happy to have shared a fun time with my new Mexican friends, and pleased to have had a chance to visit this delightful city. I feel confident that I helped reinforce links between the CSCC and the laboratory community in Latin America. My thanks to the CSCC and PACAL for this opportunity.
IFCC OFFICE
Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 Fax: (39) 02-6078-1846 E-mail: ifcc@ifcc.org Web: www.ifcc.org Office Hours: 9.00-13.00 and 14.00-18.00 Staff Members: Paola Bramati, Silvia Cattaneo, Silvia Colli-Lanzi
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European Federation of Clinical Chemistry and Laboratory Medicine
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ECCA and EDMA Advance the EU Health Literacy Debate
s part of the 2011 European Cervical Cancer Week, EDMA, the European Diagnostic Manufacturers Association, and the ECCA, the European Cervical Cancer Association jointly organized the Better Health Literacy for Better Health in Europe dinner debate in presence of Vic Blaton, EFCC past president, and some EFCC representatives. ECCA and EDMA made a timely contribution to the debate on Health Literacy at a lively dinner debate held in the Members Salon of the European Parliament on the evening of 25 January. Hosted by Irish MEP Marian Harkin, the event gathered numerous stakeholders from patient organizations, medical associations, the corporate world and the NGO community to debate how health literacy can be improved in the EU. Mrs. Harkin opened the debate by highlighting the fact that poor health literacy in Europe is a significant barrier to both EU and national goals for improving the health of Europeans.
She also noted that poor health literacy has serious economic consequences for Europe, because it is associated with increased medical interventions that run up unnecessary costs for the European healthcare systems. Dr. Philip Davies of the European Cervical Cancer Association focused on the fact that health literacy is associated with increased participation in disease prevention programs such as cervical cancer screening. Unfortunately, low health literacy accompanies social deprivation so it is therefore mainly lower socioeconomic groups across Europe that fail to take advantage of these programs, and consequently bear an inequitable burden of disease. Dr. Isabel de la Mata, principal public health advisor at DG SANCO of the European Commission, presented an overview of the efforts and the future steps the EU executive will make to foster health literacy and therefore have healthier citizens. Dr. Jrgen Schulze, president of
Photo: Mariam Harkin, MEP; Dr. Silvia De San Jos Longueras, Dr. Isabel de la Mata, DG Sanco.
EDMA, noted that the IVD industry is very concerned about health literacy in Europe and very interested to make a positive contribution to the debate. Moreover, he pledged a closer collaboration between all the involved stakeholders to bypass common prejudices and ultimately to achieve the objectives of having sustainable public finances and better empowered patients. To this end, EDMA has delivered on a long-standing commitment by launching Lab Tests Online (www. labtestsonline.info): a global, multilingual, peer-reviewed, patient-centered information portal on laboratory testing organized by the American Association for Clinical Chemistry and coordinated by EDMA in Europe.
Mandatory Accreditation for Medical Laboratories in Romania

by Camelia Grigore, RSLM-EFCC representative
omania first acknowledged the need to implement a quality management system according to international standards of medical laboratories in the late 1990s. Between 1998 and 2001, the Romanian Accreditation Body organized the first courses regarding the subject. The legislation regulating the standard of quality during that time was ISO/EN 17025. However, it was not adapted to the medical laboratory field. Moreover, the lecturers were engineers or chemists who did not use the proper medical language. The medical staff questioned the applicability of the rules with regard to the needs of a medical laboratory. Nevertheless, the Romanian Accreditation Body began the process of accreditation and an increasing number of laboratory professionals became interested in the field and received medical auditor licenses. ISO/EN 15189, introduced in 2005, resolved the shortfalls of the previous legislation. It implemented standards adapted to the medical language and needs. More and more laboratories wanted to provide evidence of the quality of their work and began implementing the new standards. In 2007, the Romanian Ministry of Health issued Order 1301/2007, providing, Starting 1 January 2008, it is
compulsory for all medical laboratories in relation with the National Health Insurance House to implement a quality management system according to ISO/EN 15189. Medical laboratories were required to have at least 10 tests accredited. It proved to be an efficient way of selecting laboratories that were competing for funds, as well as have laboratories resolve to fulfill the standards and improve their quality management system. The legislation was amended again in April 2009 when the National Health Insurance House announced, Starting 1 January 2010, it is compulsory for all medical laboratories in relation with the National Health Insurance House to be accredited according to ISO/EN 15189 for 50% of the tests.
human resources and funds to fulfill EU standards. This led to an increase in competition between public and private laboratories for available funding, with private laboratories taking the lead in development. Because public hospitals did not have sufficient resources to
develop their capacities, a significant number of hospital labs were outsourced and private laboratories became dominant on the market. Beginning with 2008, accreditation became a key objective for medical laboratories. In 2008, only around 20 laboratories received accreditation according to ISO/EN 17025 standards. During 2009 and 2010, an increasing number made efforts to fulfill the requirements, and in March cont on page 62
2011
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Were Romanian Medical Laboratories Prepared for Accreditation?

Romania did not have national guidelines regarding Good Laboratory Practices. Hospital laboratories used outdated equipment, there was no modern IT system in place, but the most pressing issue was the lack of funds to fulfill standard demands. On the other hand, laboratories operating in the private sector had access to new equipment and were able to engage
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Impressions of SFBC Symposium in Paris on Laboratory Management in Europe
by Dr. Huib Storm, National Representative The Netherlands
n April 8-9, 2011, the French Society of Clinical Biology gathered some 20 national EFCC representatives from European societies in Paris for an interesting symposium, Laboratory Management in Europe, and, noblesse oblige, the French created the right atmosphere for a fruitful and inspiring discussion about the crucial elements of our Laboratory Medicine profession. The lecture by Bernard Gouget about the French reform of the medical labs set the tune. A new French law
reorganizing the health care system includes the definition of medical biology as a medical specialty and the responsibility of the medical biologist, or as we should say now the Specialist in Laboratory Medicine, for the entire medical laboratory test procedure. This laboratory professional in France is either a medical doctor or a pharmacist specialized in medical biology. Since a number of countries are still struggling with official government regulation and recognition this French law may provide a lever for the development of
Photo: (From left to right) Dr Huib Storm, EFCC NVKC Representative, and Pr Philippe Gambert, SFBC President
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national regulation. The law also brings into line the public and private medical laboratories, which will also enforce accreditation of laboratories. It will be interesting to see whether the number of laboratories in France will decrease in the near future as a result of this new law. Why is this development so important and interesting? I think because it will stimulate the harmonization process throughout Europe with regard to patient service, best practices, EC4 register, and training. The importance of these issues was nicely illustrated by Gabriel Ko (of France, representing the angry young colleagues), Gheorge Benga (Romania), Jean-Philippe Brochet (France), Alexander Haliassos (Greece), Tomasz Anyszek (Poland), Sanja Stankovic (Serbia), Yahya Laleli (Turkey), and Camelia Grigore (Romania).
Differences between countries are nicely illustrated by comparing the number of laboratories in relation to the number of inhabitants: ranging from approx one lab per 4,000 inhabitants to one lab per 200,000 inhabitants. Also, the number of private laboratories and the number of specialists in lab medicine vary wildly, as does the activity of the leading private laboratory chains in the different countries. Clearly, a great challenge lies ahead of us. The symposium included a clear lecture by Mariam Klouche showing the ever-increasing role of Lab Tests Online in providing information to the patient. With inspiring thoughts of Yahya Laleli and Joseph Watine on collaboration in Europe for establishing better and evidence-based practices, the symposium was closed.
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Mandatory Accreditation for Medical Laboratories in Romania

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2011, the number of accredited laboratories reached 736. Private laboratories dominate the total number of accredited laboratories (92.5% or 679 medical labs), with public laboratories lagging far behind (7.4% or 55 laboratories). There are currently only 19 big private laboratories (with more than 3 laboratories) and only 4 are part of a foreign network, the remaining 660 laboratories are small with only 1-2 labs. It is obvious that funding was an important aspect in the accreditation process and public laboratories, receiving fewer funds, were unable to close the gap, despite the availability of very competent professionals working in the public healthcare sector.
the National Health Insurance House requires laboratories to receive accreditation on all reimbursed tests, the lab staff is faced with the difficult task of fulfilling standards given the constraints of the current working environment and available funding. The advantages of accreditation for Romanian laboratories include harmonization of laboratory work, suitable laboratory circuits, up-todate equipment with maintenance contracts, protocols for each lab test, modern IT systems, accurate lab reports, evidence of staff continuous medical education, increased client confidence.
Conclusion
Making accreditation of medical laboratories mandatory has been an important and beneficial step in the development of Romanian medical laboratories. The process has contributed to the increase in transparency and efficiency of medical laboratories, all to the benefit of the Romanian patient. Accreditation is not proof of which medical laboratory is best, but which is best at obeying the rules.
Accreditation Process Is Complex and Standards Difficult to Achieve

Looking at the distribution of accreditation by field, 100% of labs received accreditation on hematology tests, 95% on biochemistry, 70% on immunology, and only 45% on microbiology. Because,
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Cyprus Congress of Clinical Chemistry and Laboratory Medicine

by Spyroula Christou, EurClinChem, president of the Organising Committee
he Cyprus Association of Clinical Laboratory Directors, Biomedical and Clinical Laboratory Scientists is in a position to say that the 5th Congress of Clinical Chemistry and Laboratory Medicine held under the auspices of the Cyprus Minister of Health, the
Photo: Introduction of the EC4 Registration Commission Chair Mrs. Zerah with Dr. Eleni Theocharous, member of the European Parliament, and member of the European Health and Environment Committee.
Honorable Mr. Christos Patsalides, and the EFCC during March 18-20, 2011, at the Amathus Beach Hotel Limassol, ended with the best of impressions. The Scientific and Organizing Committee worked hard for the past 14 months so that our speakers and delegates would feel that it was a Congress of high quality and standards covering all Laboratory Disciplines, Hematology, Clinical Chemistry, Molecular Genetics, Cytogenetics, and Microbiology. Our keynote Speaker Hematology Prof. Ioannis Meletis gave a very interesting opening lecture "The peripheral blood film in the diagnostic approach of common and rare diseases. Distinguished Scientists from Cyprus (Institute of Neurology and Genetics, The Bone Marrow Donor Foundation, Cyprus University) Greece and other European countries were invited to speak at our Congress. Dr. Thomas Zima addressed the Congress on behalf of the EFCC President Dr. Rita Horvath and gave a very interesting lecture for the New Trends in Laboratory Diagnosis. The
Photo: General view of the lecture hall at the Amathus Beach Hotel Limassol.
EC4 Registration Commission Chair Mrs. Simone Zerah and the EC4 Registration Commission Secretary were also there. They introduced to the audience the role and the implementation of the EC4 Register for Specialists in Clinical Chemistry and Laboratory Medicine. The Minister of Health and the European MP Dr. Eleni Theocharous, both addressed the Congress during the opening ceremony. The many interesting lectures combined with an absolutely lovely weather, made the three day Congress a great success. The President of the
Association and President of the 5th Congress Mr. Charis Charilaou was very moved during his farewell speech on Closing Ceremony because the comments he received during the Congress overcame his expectations. Mr. Charilaou called to the podium his associates, the President of the Scientific Committee Mr. Elias Ziras, the President of the Organizing Committee Ms. Spyroula Christou and all the members of both Committees and gave his many thanks. Poster Presentation Awards were given during the closing ceremony.
EFCC Granted Recognized Stakeholder Status in EA

by Wim Huisman and Andrea Rita Horvth
s a result of ongoing strong collaboration between the European cooperation for Accreditation (EA)* and the European Federation of Clinical Chemistry and Laboratory Medicine (EFCC), EFCC has been admitted to Recognized Stakeholder Status in the EA on 13 December 2010. Recognized Stakeholders of EA are organizations with significant membership from the EU and EFTA Member States, which have a distinct international role and predominantly a proactive contribution to European social and economic matters, and bear a clear interest in and commitment towards accreditation activities. In the Recognized Stakeholder Agreement, signed by EA Chairman Graham Talbot and EFCC President Andrea Rita Horvath, both parties agreed to cooperate with the intention to further high standards in medical laboratory practice by stimulating accreditation in Europe. Due to the Agreement representatives of EFCC will be entitled to formally participate in the work of technical committees, working groups, and task forces of EA and will be informed and consulted about relevant policy and technical documents to provide inputs and comments representing the views of the
medical laboratory profession. EA and EFCC may arrange joint cultural/educational initiatives, such as conferences, seminars, workshops, training courses for the dissemination of activities related to accreditation. EFCC delegated Wim Huisman, chairman of EFCC's Working Group on Accreditation and ISO/CEN Standards, and Simone Zerah, chair of EFCC's Profession Committee as official representatives in EA. Both EFCC officers have been having long professional relationships with EA and their valuable contribution over the years has resulted in this international recognition. The "European cooperation for Accreditation" is the association of nationally recognized Accreditation Bodies of the Member States of the European Union (EU) and of the European Free Trade Association (EFTA) and of countries that have been formally identified as candidates for membership of EU and EFTA. EA's mission is to provide, through its members, effective and reliable accreditation services fulfilling at best the needs of the European economy and society. Further information about EA can be found at www.european-accreditation.org.
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INDUSTRY NEWS
Thermo Fisher to Acquire Phadia for $3.5 Billion

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The company develops, manufactures, and markets complete bloodtest systems to support the clinical diagnosis and monitoring of allergy
and autoimmune diseases. Phadia operates through two leading brands: ImmunoCAP for allergy tests and EliA for autoimmunity tests. Allergy testing is high-growth mar-
ket, with in vitro allergy testing growing 9% a year globally. About one in five people in North America and Europe suffers from allergies. The in vitro allergy testing market has significant untapped potential for growth, particularly in the United States, where there is low prevalence of allergy testing today. Autoimmunity is also a growing segment of healthcare, with more than 100 million people worldwide suffering from autoimmune disorders, including celiac disease, rheumatoid arthritis, and connective tissue diseases. The acquisition of Phadia is a major step forward in our strategy to enhance Thermo Fishers global presence in specialty diagnostics, one of our key growth platforms, said Marc N. Casper, president and CEO of Thermo Fisher Scientific (Waltham, MA, USA; www.thermofisher. com). From a market perspective, Phadia (Uppsala, Sweden; www.phadia.com) offers significant growth opportunities in the large, underpenetrated US market, and can leverage our strong presence in emerging geographies to further accelerate growth.
Thermo Fisher Buys Sterilin, Expands in Disposables

In a related development, Thermo Fisher announced the acquisition of Sterilin Ltd. (South
Wales, UK; www.sterilin.co.uk), a provider of single-use plastic products serving the microbiology, life sciences, and clinical markets. Financial details were not disclosed. The acquisition will provide Thermo Fisher with a broad portfolio of single-use laboratory products used in sample collection, storage, and analysis, including Petri dishes, specimen containers, packaging bottles, silicone tubing and fittings, and serological pipettes. Thermo Fisher will leverage its global sales and support organization to make these products more accessible to customers across Europe, Asia Pacific, and North America. The two premier brands of Thermo Fisher Scientific, Thermo Scientific and Fisher Scientific, offer a combination of continuous technology development and convenient purchasing options. The company's products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications. Chuck Kummeth, president of the Thermo Fisher Scientific laboratory consumables business, said, We continue to invest in the most up-to-date manufacturing sites and expertise throughout the globe. The acquisition of Sterilins recently expanded facilities in the UK, outfitted with the latest advanced manufacturing equipment, further underlines our strong commitment to supplying the very best laboratory consumables to meet demand at a local and global level.
HDL Acquisition Expands Fatty Acid Panel

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ealth Diagnostic Laboratory Inc. (HDL, Inc.; Richmond, VA, USA; www.myhdl.com), a College of American Pathologists (CAP) accredited laboratory specializing in health management, announced that it will expand its comprehensive test menu of risk factors and biomarkers for cardiovascular and related diseases through the acquisition of Harris Scientific, Inc., a company providing omega-3 fatty acid testing. Dr. William Harris (of Harris Scientific) will join HDL to expand his work in fatty acid analysis, and to enhance HDL's fatty acid panel of tests. This panel includes measurement of the level of omega3, omega-6, cis-monounsaturated, saturated and transfatty acids in erythrocyte membranes. By reducing inflammation, blood clotting, and improving membrane function, omega-3's can reduce risk of heart diseaseincluding fatal heart attacks and heart failureboth in persons with a history of cardiovascular disease and in healthy individuals.
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INDUSTRY NEWS
Lab21 Buys Molecular Diagnostics Concern

ab21 Ltd. (Cambridge, UK; USA; www.lab21.com) announced that it has acquired Myconostica Ltd. (Greenville, SC, USA; www.myconostica.com), a molecular diagnostic company focusing on the diagnosis of fungal infections of clinical importance. The financial terms of the deal were not disclosed. The Myconostica acquisition will provide Lab21 with its first set of nucleic acidbased assays. It will also provide manufacturing capabilities for Lab21 from which it will be able to develop and produce a range of new biomarker assays. The transaction adds new diagnostic products to Lab21's infectious disease portfolio and represents its sixth acquisition over the past two years. In addition to developing global sales of Myconostica products, Lab21 will be launching the Myconostica fungal testing services from its new reference laboratory in South Carolina (USA) as well as its laboratory in Cambridge, UK. Speaking about the transaction, Prof. David Denning of the University Hospital of South Manchester (United Kingdom) CMO of Myconostica said, "We have developed fast and sensitive molecular diagnostics for life threatening fungal infections such as aspergillosis and Pneumocystis pneumonia that will transform patient care for these infections. Fungal infections are frequently underdiagnosed using current diagnostic methods and are much more common than realized." A UK-based medical diagnostic company, Myconostica Ltd. is a spinout from the University of Manchester. Traditional methods of the detection of fungal infections are relatively insensitive and slow. Myconostica is developing and commercializing a portfolio of real-time molecular diagnostic tests for life-threatening fungal infections. Over 10 million people are at risk of these infections each year in Europe and North America alone. Aspergillosis affects leukemia, transplant, and corticosteroid-treated patients, including asthma and chronic obstructive pulmonary disease (COPD). Pneumocystis affects human immunodeficiency virus (HIV)-infected and AIDS patients as well as many others with suboptimal immune symptoms. Myconostica has three CE-marked products on the market in Europe, Canada, and Southern Africa, launched in 2010, capable of running on a wide range of testing platforms. These include a product for extracting fungal DNA from human samples and tests for the detection of Aspergillus and Pneumocystis jirove. The global market for fast and reliable invasive fungal infection diagnosis is substantial, with more than 10 million patients each year at risk of life threatening fungal infections.
PerkinElmer Buys Provider of Lab Notebook Solutions

erkinElmer's (Waltham, MA, USA; www. perkinelmer.com) software company has bought the electronic laboratory notebook provider Labtronics (Guelph, Canada; www.labtronics.com). Labtronics provides procedure-based electronic laboratory notebook (ELN) solutions for laboratories performing routine analysis in multiple industries. Financial details of the deal were not disclosed. The Labtronics acquisition follows the purchase of informatics companies CambridgeSoft and ArtusLabs by PerkinElmer in March 2011 for US$220 million. CambridgeSoft and ArtusLabs anticipate combined revenues of about $65 million, according to PerkinElmer, which finished 2010 with about $1.7 billion in revenue. The addition of Labtronics solutions extends
PerkinElmers ELN and data-integration software offerings into laboratories following strict routine procedures such as regulated and nonregulated quality assurance/quality control (QA/QC), late-stage product or method development laboratories, and environmental and food testing labs. Labtronics' tools can be applied to any procedure-based problem including laboratory analysis, equipment calibration, and validation, and cleaning validation, notes PerkinElmer. Dusty Tenney, president, analytical sciences and laboratory services, PerkinElmer said, This acquisition successfully positions PerkinElmer as the only technology provider able to deploy an optimized ELN solution across a global customers entire value chain, from research to manufacturing.
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Influenza Detection Assay Undergoing Clinical Trials

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