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REAGENTS QUALITY CONTROL

One Step Drug Screen Test Device (Urine)


The test contains mouse monoclonal antibody-coupled particles and corresponding drug-protein conjugates. A A procedural control is included in the test. A coloured line appearing in the control line region (C) is
Package Insert goat antibody is employed in the control line. considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane
wicking and correct procedural technique.
PRECAUTIONS Control standards are not supplied with this kit. However, it is recommended that positive and negative
English
• For medical and other professional in vitro diagnostic use only. Do not use after the expiration date. controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.
Package insert for testing of the following drugs: • The test device should remain in the sealed pouch until use. LIMITATIONS
Amphetamine, Amphetamine 300, Barbiturates, Benzodiazepines, Benzodiazepines 200, Buprenorphine, • All specimens should be considered potentially hazardous and handled in the same manner as an
Cocaine, Cocaine 150, Marijuana, Marijuana 20, Methadone, EDDP 300 (Methadone metabolite), 1. The ConcatenoTM One Step Drug Screen Test Device (Urine) provides only a qualitative, preliminary
infectious agent.
Methamphetamine, Methamphetamine 500, Methamphetamine 300, Methylenedioxymethamphetamine, analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas
• The used test device should be discarded according to local regulations.
Morphine 300, Opiate 2000, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.2, 3
STORAGE AND STABILITY 2. There is a possibility that technical or procedural errors, as well as other interfering substances in the urine
A rapid, one step screening test for the simultaneous, qualitative detection of drugs and drug metabolites in
specimen may cause erroneous results.
human urine. Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test device is
3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of
For medical and other professional in vitro diagnostic use only. stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed
the analytical method used. If adulteration is suspected, the test should be repeated with another urine
pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
INTENDED USE & SUMMARY specimen.
SPECIMEN COLLECTION AND PREPARATION 4. A positive result does not indicate level or intoxication, administration route or concentration in urine.
Urine based tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. 5. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug
The speed and sensitivity of immunoassays have made them the most widely accepted method to screen urine Urine Assay
is present but below the cut-off level of the test.
for drugs of abuse. The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may 6. The test does not distinguish between drugs of abuse and certain medications.
The ConcatenoTM One Step Drug Screen Test Device (Urine) is a lateral flow chromatographic immunoassay be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to 7. A positive result may be obtained from certain foods or food supplements.
for the qualitative detection of drugs and drug metabolites in urine at the following cut-off concentrations in obtain a clear supernatant for testing.
PERFORMANCE CHARACTERISTICS
urine:1 Specimen Storage
Accuracy
Test Calibrator Cut-off (ng/mL) Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens A side-by-side comparison was conducted using the ConcatenoTM One Step Drug Screen Test Device (Urine)
Amphetamine (AMP) d-Amphetamine 1,000 may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed well before testing. and a commercially available drug rapid test. Testing was performed on approximately 300 specimens
Amphetamine (AMP 300) d-Amphetamine 300 MATERIALS previously collected from subjects presenting for Drug Screen Testing. Presumptive positive results were
Barbiturates (BAR) Secobarbital 300 confirmed by GC/MS. Negative urine specimens were screened initially by Predicate test, 10% negative
Materials Provided specimens were confirmed by GC/MS. The following results were tabulated:
Benzodiazepines (BZO) Oxazepam 300
Benzodiazepines (BZO 200) Oxazepam 200 • Test devices • Droppers • Package insert % Agreement with Commercial Kit
Buprenorphine (BUP) Buprenorphine 10 Materials Required But Not Provided AMP BZO COC
Specimen AMP BAR BZO BUP** COC THC THC 20 MTD
Cocaine (COC) Benzoylecgonine 300 300 200 150
• Specimen collection container • Timer Positive 96% >99% >99% 90% * 88% 95% >99% >99% * >99%
Cocaine (COC 150) Benzoylecgonine 150
Marijuana (THC) 11-nor-∆9-THC-9 COOH 50 DIRECTIONS FOR USE Negative >99% >99% 99% 97% * >99% >99% >99% >99% * >99%
Marijuana 20 (THC 20) 11-nor-∆9-THC-9 COOH 20 Total 98% >99% 99% 94% * 97% 98% >99% >99% * >99%
Allow the test, urine specimen, and/or controls to reach room temperature (15-30ºC) prior to testing.
Methadone (MTD) Methadone 300
1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and EDDP MET MET MOP OPI
2-Ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine Specimen MET MDMA OXY PCP PPX TCA
EDDP 300 (EDDP)
(EDDP)
300 use it as soon as possible. 300 500 300 300 2000
2. Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of Positive * 99% >99% * >99% >99% >99% * 96% >99% 95%
Methamphetamine (MET) d-Methamphetamine 1,000
urine (approx. 100 µL) to the specimen well (S) of the test device, and then start the timer. Avoid trapping Negative * >99% 82% * 99% >99% >99% * >99% >99% >99%
Methamphetamine (MET 500) d-Methamphetamine 500
air bubbles in the specimen well (S). See the illustration below. Total * 99% 89% * 99% >99% >99% * 99% >99% 99%
Methamphetamine (MET 300) d-Methamphetamine 300
3. Wait for the coloured line(s) to appear. Read results at 5 minutes. Do not interpret the result after * NOTE: Commercial kit unavailable for comparison testing.
Methylenedioxymethamphetamine (MDMA) d,l-Methylenedioxymethamphetamine 500
10 minutes. ** NOTE: BUP was compared to the self-reported use of Buprenorphine
Morphine (MOP 300) Morphine 300
Opiate (OPI 2000) Morphine 2,000 % Agreement with GC/MS
3 Drops of Urine
Oxycodone (OXY) Oxycodone 100 Specimen AMP
AMP
BAR BZO
BZO
BUP* COC
COC
THC THC 20 MTD
Phencyclidine (PCP) Phencyclidine 25 300 200 150
Propoxyphene (PPX) Propoxyphene 300 Positive 96% >99% 92% 96% 98% 98% 96% 99% 98% 91% 99%
Tricyclic Antidepressants (TCA) Nortriptyline 1,000 Negative 95% 99% 98% 96% 99% 99% 90% >99% 87% 99% 94%
Total 95% 99% 95% 96% 99% 99% 93% 99% 91% 96% 96%
This test will detect other related compounds, please refer to the Analytical Specificity table in this
package insert. Negative Positive Invalid EDDP MET MET MOP OPI
Specimen MET MDMA OXY PCP PPX TCA**
This assay provides only a preliminary analytical test result. A more specific alternate chemical 300 500 300 300 2000
method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass Positive >99% 99% 99% 98% >99% >99% >99% 98% >99% 94% >99%
spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional Negative 94% 93% 96% >99% 98% 94% 90% 99% 97% 99% 89%
judgment should be applied to any drug of abuse test result, particularly when preliminary positive Total 96% 96% 97% 99% 99% 97% 95% 99% 98% 97% 91%
results are used. INTERPRETATION OF RESULTS
*NOTE: BUP was based on LC/MS data instead of GC/MS.
PRINCIPLE (Please refer to the illustration above) **NOTE: TCA was based on HPLC data instead of GC/MS.
TM
The Concateno One Step Drug Screen Test Device (Urine) is an immunoassay based on the principle of NEGATIVE:* Two lines appear. One coloured line should be in the control line region (C), and another Analytical Sensitivity
competitive binding. Drugs which may be present in the urine specimen compete against their respective drug apparent coloured line should be in the test line region (T). This negative result indicates that the drug
concentration is below the detectable level. A drug-free urine pool was spiked with drugs to the concentrations at ±50% cut-off and ±25% cut-off. The
conjugate for binding sites on their specific antibody.
results are summarized below.
During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen *NOTE: The shade of colour in the test line region (T) will vary, but it should always be considered as
below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will negative whenever there is even a faint coloured line. Drug Conc. AMP AMP 300 BAR BZO BZO 200 BUP COC
then react with the drug-protein conjugate and a visible coloured line will show up in the test line region. The POSITIVE: One coloured line appears in the control line region (C). No line appears in the test line (Cut-off range) - + - + - + - + - + - + - +
presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, region (T). This positive result indicates that the drug concentration exceeds the detectable level. 0% Cut-off 30 0 30 0 30 0 30 0 90 0 90 0 30 0
the coloured line will not form in the test line region. -50% Cut-off 30 0 30 0 30 0 30 0 90 0 90 0 30 0
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques
A drug-positive urine specimen will not generate a coloured line in the test line region because of drug are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test. -25% Cut-off 23 7 25 5 20 10 26 4 81 9 78 12 30 0
competition, while a drug-negative urine specimen will generate a line in the test line region because of the If the problem persists, discontinue using the lot immediately and contact your local distributor. Cut-off 9 21 16 14 13 17 12 18 54 36 48 42 9 21
absence of drug competition. To serve as a procedural control, a coloured line will always appear at the control +25% Cut-off 1 29 4 26 8 22 3 27 25 65 24 66 7 23
line region, indicating that proper volume of specimen has been added and membrane wicking has occurred. +50% Cut-off 0 30 0 30 0 30 0 30 0 90 0 90 0 30
Drug Conc. COC 150 THC THC 20 MTD EDDP 300 MET MET 500 BENZODIAZEPINES BENZODIAZEPINES 200 Non Cross-Reacting Compounds
(Cut-off range) - + - + - + - + - + - + - + Oxazepam 300 Alprazolam 195 Acetophenetidin l-Cotinine Ketamine d-Pseudoephedrine
0% Cut-off 30 0 30 0 30 0 30 0 90 0 30 0 30 0 Alprazolam 196 α-Hydroxyalprazolam 1,562 N-Acetylprocainamide Creatinine Ketoprofen Quinidine
-50% Cut-off 30 0 30 0 30 0 30 0 90 0 30 0 30 0 α-Hydroxyalprazolam 1,262 Bromazepam 390 Acetylsalicylic acid Deoxycorticosterone Labetalol Quinine
-25% Cut-off 27 3 10 20 29 1 26 4 90 0 24 6 27 3 Bromazepam 1,562 Chlordiazepoxide 780 Aminopyrine Dextromethorphan Loperamide Salicylic acid
Cut-off 13 17 4 26 19 11 16 14 51 39 18 12 13 17 Chlordiazepoxide 1,562 Clobazam 390 Amoxicillin Diclofenac Meprobamate Serotonin
+25% Cut-off 7 23 3 27 6 24 4 26 13 77 1 29 7 23 Clobazam 98 Clorazepate 1,562 Ampicillin Diflunisal Methoxyphenamine Sulfamethazine
+50% Cut-off 0 30 0 30 0 30 0 30 0 90 0 30 0 30 Clonazepam 781 Desalkylflurazepam 1,000 l-Ascorbic acid Digoxin Methylphenidate Sulindac
Clorazepate 195 Diazepam 200 Apomorphine Diphenhydramine Nalidixic acid Tetracycline
Drug Conc. MET 300 MDMA MOP OPI 2000 OXY PCP PPX TCA Delorazepam 1,562 Estazolam 780 Aspartame Ethyl-p-aminobenzoate Naproxen Tetrahydrocortisone,
(Cut-off range) - + - + - + - + - + - + - + - + Desalkylflurazepam 390 Flunitrazepam 12,500 Atropine β-Estradiol Niacinamide 3-acetate
0% Cut-off 30 0 30 0 30 0 30 0 30 0 30 0 30 0 30 0 Diazepam 195 (+)-Lorazepam 100,000 Benzilic acid Estrone-3-sulfate Nifedipine Tetrahydrocortisone
-50% Cut-off 30 0 30 0 30 0 30 0 30 0 30 0 30 0 30 0 Estazolam 2,500 Midazolam 6,250 Benzoic acid Erythromycin Norethindrone Tetrahydrozoline
-25% Cut-off 27 3 23 7 28 2 30 0 30 0 26 4 26 4 25 5 Flunitrazepam 390 Nitrazepam 100 Bilirubin Fenoprofen Noscapine Thiamine
Cut-off 15 15 15 15 20 10 5 25 21 9 11 19 19 11 16 14 d,l-Lorazepam 1,562 Norchlordiazepoxide 3,125 d,l-Brompheniramine Furosemide d,l-Octopamine Thioridazine
+25% Cut-off 5 25 6 24 3 27 4 26 6 24 8 22 8 22 3 27 RS-Lorazepam glucuronide 1,562 Nordiazepam 780 Caffeine Gentisic acid Oxalic acid d,l-Tyrosine
+50% Cut-off 0 30 0 30 0 30 0 30 0 30 0 30 0 30 0 30 Midazolam 12,500 Oxazepam 200 Cannabidiol Hemoglobin Oxolinic acid Tolbutamide
Chloral hydrate Hydralazine Oxymetazoline Triamterene
Nitrazepam 98 Sertraline 12,500
Analytical Specificity Chloramphenicol Hydrochlorothiazide Papaverine Trifluoperazine
Norchlordiazepoxide 195 Temazepam 100
The following table lists the concentration of compounds (ng/mL) that are detected positive in urine by the Chlorothiazide Hydrocortisone Penicillin-G Trimethoprim
Nordiazepam 390 Triazolam 50,000
ConcatenoTM One Step Drug Screen Test Device (Urine) at 5 minutes. Temazepam 98 7-Aminoflunitrazepam 200
d,l-Chlorpheniramine o-Hydroxyhippuric acid Perphenazine d,l-Tryptophan
Chlorpromazine 3-Hydroxytyramine Phenelzine Uric acid
AMPHETAMINE METHYLENEDIOXYMETHAMPHETAMINE (MDMA) Triazolam 2,500 7-Aminonitrazepam 5,000
Cholesterol d,l-Isoproterenol Prednisone Verapamil
d-Amphetamine 1,000 3,4-Methylenedioxymethamphetamine (MDMA) 500 METHADONE 7-Aminoclonazepam >100,000
Clonidine Isoxsuprine d,l-Propanolol Zomepirac
d,l-Amphetamine 3,000 3,4-Methylenedioxyamphetamine (MDA) 3,000 Methadone 300 EDDP 300
Cortisone
l-Amphetamine 50,000 3,4-Methylenedioxyethylamphetamine (MDEA) 300 Doxylamine 50,000 2-Ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300
Phentermine 3,000 METHAMPHETAMINE PHENCYCLIDINE MORPHINE 300 BIBLIOGRAPHY
3,4- Methylendioxyamphetamine (MDA) 2,000 d-Methamphetamine 1,000 Phencyclidine 25 Morphine 300
1. Tietz NW. Textbook of Clinical Chemistry. W.B. Saunders Company. 1986; 1735
AMPHETAMINE 300 p-Hydroxymethamphetamine 30,000 4-Hydroxyphencyclidine 12,500 Codeine 300 2. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 2nd Ed. Biomedical Publ., Davis, CA.
d-Amphetamine 300 l-Methamphetamine 8,000 PROPOXYPHENE Ethylmorphine 6,250 1982; 488
d,l-Amphetamine 390 Mephentermine 50,000 d-Propoxyphene 300 Hydrocodone 50,000 3. Hawks RL, CN Chiang. Urine Testing for Drugs of Abuse. National Institute for Drug Abuse (NIDA),
l-Amphetamine 50,000 3,4-Methylenedioxymethamphetamine (MDMA) 2,000 d-Norpropoxyphene 300 Hydromorphone 3,125 Research Monograph 73, 1986
3,4-Methylendioxyamphetamine (MDA) 1,560 METHAMPHETAMINE 300 TRICYCLIC ANTIDEPRESSANTS Levorphanol 1,500
p-Hydroxyamphetamine 1,560 d-Methamphetamine 300 Nortriptyline 1,000 6-Monoacetylmorphine (6-MAM) 400
β-Phenylethylamine 100,000 d,l-Amphetamine 100,000 Nordoxepin 1,000 Morphine 3-β-D-glucuronide 1,000
Tyramine 100,000 Chloroquine 25,000 Trimipramine 3,000 Norcodeine 6,250
p-Hydroxynorephedrine 100,000 p-Hydroxymethamphetamine 25,000 Amitriptyline 1,500 Normorphine 100,000
Phenylpropanolamine (d,l-Norephedrine) 100,000 l-Methamphetamine 3,125 Index of Symbols
Promazine 1,500 Oxycodone 30,000
BARBITURATES 3,4-Methylenedioxymethamphetamine (MDMA) 780 Desipramine 200 Oxymorphone 100,000 Attention, see instructions
Tests per kit Manufacturer
Secobarbital 300 Mephentermine 50,000 Imipramine 400 Procaine 15,000 for use
Amobarbital 300 (1R,2S)-(-)-Ephedrine 100,000 Clomipramine 12,500 Thebaine 6,250 For in vitro
Use by Do not reuse
Alphenal 150 l-Epinephrine 50,000 Doxepin 2,000 OPIATE 2000
diagnostic use only
Aprobarbital 200 Ephedrine 100,000 Maprotiline 2,000 Morphine 2,000 Store between 2-30°C Lot Number REF Catalog #
Butabarbital 75 Fenfluramine 12,500 Promethazine 25,000 Codeine 2,000
Butethal 100 Trimethobenzamide 25,000 MARIJUANA Ethylmorphine 5,000
Butalbital 2,500 METHAMPHETAMINE 500 11-nor-∆9-THC-9 COOH 50 Hydrocodone 12,500 Manufactured for
Cyclopentobarbital 600 d-Methamphetamine 500 Cannabinol 20,000 Hydromorphone 5,000 Concateno plc
Pentobarbital 300 p-Hydroxymethamphetamine 15,000 92 Milton Park, Abingdon,
11-nor-∆8-THC-9 COOH 30 Levorphanol 75,000
Oxfordshire OX14 4RY, UK
Phenobarbital 100 l-Methamphetamine 4,000 ∆8-THC 15,000 6-Monoacetylmorphine (6-MAM) 5,000 Tel: 0800 169 5167
BUPRENORPHINE Mephentermine 25,000 ∆9-THC 15,000 Morphine 3-β-D-glucuronide 2,000 Email: enquiries@concateno.com
Buprenorphine 10 d,l-Amphetamine 75,000 MARIJUANA 20 Norcodeine 12,500
Norbuprenorphine 20 (1R,2S)-(-)-Ephedrine 50,000 11-nor-∆9-THC-9 COOH 20 Normorphine 50,000
Buprenorphine 3-D-glucuronide 15 β-Phenylethylamine 75,000 Cannabinol 12,500 Oxycodone 25,000
Norbuprenorphine 3-D-glucuronide 200 3,4-Methylenedioxymethamphetamine (MDMA) 1,000 11-nor-∆8-THC-9 COOH 20 Oxymorphone 25,000
COCAINE d-Amphetamine 50,000 ∆8-THC 10,000 Procaine 150,000
Benzoylecgonine 300 Chloroquine 12,500 ∆9-THC 12,500 Thebaine 100,000
Cocaine 780 l-Phenylephrine 100,000
Cross-Reactivity
Cocaethylene 12,500 OXYCODONE
Ecgonine 32,000 Oxycodone 100 A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free urine
or Amphetamine, Amphetamine 300, Barbiturates, Benzodiazepines, Benzodiazepines 200, Buprenorphine,
COCAINE 150 Hydrocodone 6,250
Cocaine, Cocaine 150, Marijuana, Marijuana 20, Methadone, EDDP 300, Methamphetamine,
Benzoylecgonine 150 Hydromorphone 50,000 Methamphetamine 500, Methamphetamine 300, Methylenedioxymethamphetamine, Morphine 300, Opiate
Cocaine 400 Levorphanol 50,000 2000, Oxycodone, Phencyclidine, Propoxyphene, Tricyclic Antidepressants positive urine. The following Number: C4650 Number: 1155954501
Cocaethylene 6,250 Naloxone 37,500 compounds show no cross-reactivity when tested with the ConcatenoTM One Step Drug Screen Test Device
(Urine) at a concentration of 100 µg/mL. Edition: 001 Effective date: 2008-xx-xx
Ecgonine 12,500 Naltrexone 37,500
Ecgonine methylester 50,000 Oxymorphone 200