A rapid, one step test for the qualitative detection of Cocaine Metabolite in human urine.

For healthcare professionals including professionals at point of care sites.

For in vitro diagnostic use only.

MOR/MET/THC/AMP/MDMA/MTD/COC/TCA/BAR/BZO, up to 15 kinds of Drug Tests

Format: Strip, Cassette, Cup,and Panel 

INTENDED USE

The  COC One Step Cocaine Test Strip is a rapid chromatographic immunoassay for the qualitative detection of cocaine metabolite, Benzoylecgonine, in human urine at a cut-off concentration of 300 ng/mL.

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

PRINCIPLE

The COC One Step Cocaine Test Strip is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.

During testing, a urine specimen migrates upward by capillary action. Benzoylecgonine, if present in the urine specimen below 300 ng/mL, will not saturate the binding sites of antibody in the test strip. The antibody coated particles will then be captured by immobilized Benzoylecgonine conjugate and a visible colored line will appear in the test line region. The colored line will not form in the test line region if the Benzoylecgonine level exceeds 300 ng/mL because it will saturate all the binding sites of anti-Benzoylecgonine antibody.

A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region.

To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

POSITIVE: One colored line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the Benzodiazepines concentration exceeds the detectable level.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test strip. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

LIMITATIONS

1.        The COC One Step Cocaine Test Strip provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.

2.        It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.

3.        Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.

4.        A Positive Result indicates presence of the drug or its metabolites but does not indicate level of intoxication, administration route or concentration in urine.