Total Solutions for

Clinical Diagnosis
Total Solutions for Clinical Diagnosis 1
HbA1c Clinical Significance, Disease Diagnosis and Principle

Clinical Significance : HbA1c is one of the glycated hemoglobins, a subfraction

formed by the attachment of various glucose to the Hb molecule.

Disease Diagnosis :The Diagnosis of Diabetes Mellitus is done through HbA1c

testing.

Principle :The principle of the test is a based upon Immuno Turbidimetric

method.

Usage :HbA1c is tested in Hospital Laboratories, Laboratory Chains, Individual

Laboratories,Diabetic Centers,Cardiac Hospitals and Clinics,Nursing Homes,
etc.
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Total Solutions for Clinical Diagnosis

HbA1c Kit –Features and benefits

Features Benefits
Greater Sensitivity of 3.3% with advanced • Its Liquid stable, ready to
Immuno Turbidimetric Method. use and supplied along with
4X Longer Shelf Life ( 24 months @ 2-8Deg.C & 1 calibrators .
Month on Board) • The Kit is equivalent to
5X Longer Calibration Stability ( 30 days) Gold Standard HPLC
99 % Correlation with HPLC method.
Linearity of 15.7 % as per Industry Standards. • It is adaptable to all open
Standardised to IFCC reference Fully auto Analyzers and
method.Convenient Pack Size Semiauto Analyzers.
The normal range for Non Diabetics : 4-6%; Target of Therapy < 7 %; Change of
Therapy - > 8%
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Total Solutions for Clinical Diagnosis

HbA1c Competition and Comparatives

HbA1c HbA1c HbA1c

Make Linearity Method

Enhanced Immuno
TBM 15.7 % Turbidimetric

Competitor A(Agappe) 13%Immunoturbidimetric

Competitor C ( Beckman) 14.5 %Immunoturbidimetric

Total Solutions for Clinical Diagnosis

Micro Albumin Clinical Significance, Disease Diagnosis and Principle

Clinical Significance : Microalbumin is an albumin excreted in the urine and is a

sensitive marker of nephropathy. Slightly elevated albumin excretion in urine, called
microalbuminuria, is of particular importance in the early diagnosis of diabetic
nephropathy.

Disease Diagnosis :It is used to screen for early renal disease in diabetic patients.

Principle :The principle of this test is a based upon Immuno Turbidimetric method.

Usage : Micro Albumin is tested in the Hospital Laboratories, Laboratory Chains,

Individual Laboratories, Diabetic Centers, Cardiac Hospitals & Clinics,Nursing Homes,
etc. 5

Total Solutions for Clinical Diagnosis

Micro Albumin Kit –Features and benefits

Features Benefits
• Quantitative estimation of Microalbumin
• Calibrator included
• Small and Big pack size • Ready to use R1 and R2
• Wide measuring range of 0- 400 mg/L Reagents,hence there is no
• No Hook effect up to 6000 mg/L need of reagent
• Additional Quality Controls available preparation
• No interference from Triglycerides up to 2500 • The Kit is Adaptable to Fully
mg/dl, Bilirubin up to 15 mg/dl and Semi Auto Analyzers.
• Longer shelf life of 24 months
Normal range of Micro Albumin is from 0–25 mg/l (IFCC)

Total Solutions for Clinical Diagnosis

Micro Albumin-Competition and Comparatives

Micro Albumin Micro Albumin Microalbumin

Make Linearity Method

TBM 550 mg/L Immunoturbidimetric

CompetitorA- Agappe 395 mg/L Immunoturbidimetric

400 mg/L
Competitor B-Roche Immunoturbidimetric

Total Solutions for Clinical Diagnosis

ASO - Clinical Significance, Disease Diagnosis and Principle

Clinical Significance : Anti Streptolysin (ASO) is a toxic immunogenic exo enzyme

produced by –ß heamolitic Streptococci of groups A, C and G.

Disease Diagnosis : Measuring the ASO antibodies are useful for the diagnosis of
Rheumatoid Fever, Streptococcal infections etc .

Principle : The principle of this test is a based upon Immuno Turbidimetric method.

Usage : ASO is tested in Hospital Laboratories, Laboratory Chains, Individual

Laboratories, Orthopedic Hospitals, Nursing Homes, etc.

Total Solutions for Clinical Diagnosis

ASO Kit –Features and benefits

Features Benefits
• Quantitative estimation of ASO
• Calibrator included • Ready to use R1 and R2
• XL-System Pack Kits and T-LTX Reagents provided along with
Liquixx Kits the Kit
• Measuring range from 20 IU/ml - • XL-System Pack Kits for Fully
800 IU/ml Auto Analyzers and T-LTX Kits
• Additional Quality Controls for Semi Auto Analyzer to suit
• Longer shelf life of 24 months all type of customers.

Normal range of ASO is up to 200 IU/mL

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Total Solutions for Clinical Diagnosis

ASO-Competition and Comparatives

ASO ASO
Make Linearity Method

TBM 800 IU/ml Immunoturbidimetric

24 Months Shelf Life which is higher than Competitors

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Total Solutions for Clinical Diagnosis

RF - Clinical Significance, Disease Diagnosis and Principle

Clinical Significance : RF( Rheumatoid factor) is a term used to describe a

variety of antibodies (in most cases of the IgM type) that will react with
modified human IgG (e.g. IgG in circulating immune complexes, IgG
adsorbed to latex, etc.)
Disease Diagnosis :Elevated RF is found in collagen vascular diseases such
as SLE, rheumatoid arthritis, scleroderma, leprosy, tuberculosis, syphilis,
malignancy, thyroid disease etc
Principle :The principle of this test is based upon Immuno Turbidimetric
method
Usage :RF is tested in Hospital Laboratories, Laboratory Chains, Individual
Laboratories, Orthopedic Hospitals, Nursing Homes, etc.

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Total Solutions for Clinical Diagnosis

RF Kit –Features and benefits

Features Benefits
• Quantitative estimation of RF
• Calibrator included • It contains ready to use R1
• XL-System Pack Kits and T-LTX Liquixx Kits and R2 Reagents
• Measuring range from 6 IU/ml - 160 IU/ml • XL-System Pack Kits for
• Additional Quality Controls Fully Auto Analyzers and
• Longer shelf life of 24 months T-LTX Kits for Semi Auto
Analyzers to suit all type
of customers.
Normal range up to 20 IU/mL

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Total Solutions for Clinical Diagnosis

RF-Competition and Comparatives

RF RF RF
Make Linearity Method

TBM 160 IU/ml Immunoturbidimetric

CompetitorA- Agappe 135 IU/ml Immunoturbidimetric

TbM provides 24 Months Shelf Life of the RF which is higher than Competitors

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Total Solutions for Clinical Diagnosis

CRP – Its Clinical Significance,Disease Diagnosis and Principle

Clinical Significance of CRP : C-reactive protein is the classic acute phase

protein in inflammatory reactions. It is synthesized by the liver and consists
of five identical polypeptide chains .

Disease Diagnosis :Increased CRP levels are found in inflammatory conditions

including: bacterial infection, rheumatic fever, active arthritis, malignancies
and in the post-operative state.

Principle :The principle of this test is a based upon Immuno Turbidimetric

method
Usage :CRP is tested in the Hospital Laboratories, Laboratory Chains,
Individual Laboratories, Orthopedic Hospitals, Nursing Homes, etc.

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Total Solutions for Clinical Diagnosis

CRP Kit –Features and benefits

Features Benefits
• Quantitative estimation of CRP • Ready to use R1 and R2
• Calibrator is included Reagents
• XL-System Pack Kits and T-LTX Liquixx Kits • XL-System Pack Kits for Fully
• Measuring range from 2 mg/L -65 mg/L Auto Analyzers and T-LTX
• Additional Quality Controls Kits for Semi Auto Analyzer
• Longer shelf life of 24 months to suit all type of customers.

• The normal range is up to 6 mg/L

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Total Solutions for Clinical Diagnosis

CRP-Competition and Comparatives

CRP CRP CRP

Make Linearity Method

TBM 65 mg/l Immunoturbidimetric

24 Months Shelf Life which is higher than Competitors

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Total Solutions for Clinical Diagnosis

Direct HDL Cholesterol - Clinical Significance, Disease Diagnosis and Principle

Clinical Significance : High-density lipoproteins (HDL) are synthesized in liver as

complexes of apolipoprotein and phospholipids. It is capable of picking up
cholesterol and carrying it from arteries to the liver, where cholesterol is
converted to bile acids and excreted into the intestine.

Disease Diagnosis :HDL cholesterol is inversely related to the risk for

cardiovascular disease.

Principle :The Principle of the Kit is modified PVS (polyvinyl sulfonic acid) &
PEGME(polyethyleneglycol methyl ether) Plus Selective detergent method.

Usage :HDL Kit is tested in the Hospital Laboratories, Laboratory Chains,

Individual Laboratories,Cardiac Hospitals and Clinics,Nursing Homes, etc.
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Total Solutions for Clinical Diagnosis

Direct HDL Cholesterol Kit –Features and benefits

Features Benefits
• Quantitative estimation of Direct HDL Cholesterol
• Calibrator included • No Precipitation required.
• Measuring range from 1.9 mg/dl – 193 mg/dl • True Direct HDL value
• 24 months shelf life without any interferences.
• Ready to use R1 and R2
Reagents
• XL-System Pack Kits for Fully
Auto Analyzers and Liquixx
Kits for Semi Auto Analyzers
The normal range for Adults male: 35.3 mg/dl –
79.5 mg/dl; Adults female: 42.0 mg/dl – 88.0 mg/dl

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Total Solutions for Clinical Diagnosis

Direct HDL Cholesterol -Competition and Comparatives

HDL HDL HDL

Make Linearity Method
PVS/PEGME & Selective
TBM 193 mg/dl Detergents

CompetitorA- Agappe 150 mg/dl Selective Inhibition

Competitor B- 180 mg/dl Homogeneous Method

TBM -NIST (National Institute of Standards and Technology) Approved

WHO Approved.
Competitors do not have NIST approvals of their Kits.
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Total Solutions for Clinical Diagnosis

Direct LDL Cholesterol - Clinical Significance, Disease Diagnosis and Principle

Clinical Significance : Direct Low Density Lipoproteins (LDL) are synthesized in the liver by the
action of various lipolytic enzymes on triglyceride-rich Very Low Density Lipoproteins (VLDLs).

Disease Diagnosis : Direct LDL cholesterol is a key factor in the pathogenesis of atherosclerosis
and Coronary Artery Disease (CAD)

Principle :The Principle of the Kit is modified PVS(polyvinyl sulfonic acid) &
PEGME(polyethyleneglycol methyl ether) Plus Selective detergent method.

Usage : Direct LDL Kit is tested in Hospital Laboratories, Laboratory Chains, Individual
Laboratories,Cardiac Hospitals and Clinics ,Nursing Homes, etc.

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Total Solutions for Clinical Diagnosis

Direct LDL Cholesterol Kit –Features and benefits

Features Benefits
• Quantitative estimation of Direct LDL Cholesterol • No calculation required.
• Calibrator included • True Direct LDL value
• Measuring range from 2.60 mg/dl – 263 mg/dl without any
• 24 months shelf life interferences.
• Ready to use R1 and R2
Reagents
• XL-System Pack Kits for
Normal range of Direct LDL Cholesterol is Less than 100 Fully Auto Analyzers and
mg/dl – optimal;100 – 129 mg/dl – near/above optimal; Liquixx Kits for Semi Auto
130 – 159 mg/dl – borderline high; 160 – 189 mg/dl – high; Analyzer to suit all type
≥190 mg/dl – very high of customers.
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Total Solutions for Clinical Diagnosis

Direct LDL Cholesterol-Competition and Comparatives

Direct LDL Direct LDL Direct LDL

Make Linearity Method

PVS/PEGME & Selective

TBM 263 mg/dl Detergents
TBM - NIST (National Institute of Standards and Technology) Approved
WHO Approved
Competitors do not have NIST approvals of their Kits.

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Total Solutions for Clinical Diagnosis

Transasia Bio-Medicals Ltd.
Email: responses@transasia.co.in
Website: www.erbamannheim.com

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Total Solutions for Clinical Diagnosis