One-Step COC Rapid Test

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.

SUMMARY

Cocaine is a potent central nervous system (CNS) stimulant and a local anesthetic. Initially, it brings about extreme energy and restlessness while gradually resulting in tremors, over-sensitivity and spasms. In large amounts, cocaine causes fever, unresponsiveness, and difficulty in breathing and unconsciousness.

Cocaine is often self-administered by nasal inhalation, intravenous injection and free-base smoking. It is excreted in the urine in a short time primarily as Benzoylecgonine ^{1, 2}. Benzoylecgonine, a major metabolite of cocaine, has a longer biological half-life (5 - 8 hours) than cocaine (0.5 - 1.5 hours), and can generally be detected for 24-48 hours after cocaine exposure.²

The COC One Step Cocaine Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of cocaine metabolite in urine. The COC One Step Cocaine Test Strip yields a positive result when the cocaine metabolite in urine exceeds 300 ng/mL. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA).

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.

REAGENTS

The test strip contains monoclonal anti-Benzoylecgonine antibody-coupled particles and Benzoylecgonine-protein conjugate. A goat antibody is employed in the control line system.

PRECAUTIONS

· For healthcare professionals including professionals at point of care sites.

· For professional in vitro diagnostic use only. Do not use after the expiration date.

· The test strip should remain in the sealed pouch until use.

· All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

· Used test strip should be discarded according to federal, state and local regulations.

STORAGE AND STABILITY

Store as packaged in the sealed pouch at 2-30°C. The test strip is stable through the expiration date printed on the sealed pouch. The test strips must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

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