PROFESSIONAL/ HOME DRUG TEST KIT
Cocaine - Strips
The One-Step Cocaine Test is a lateral flow, one-step immunoassay for the qualitative detection of benzoylecgonine (cocaine metabolite) in human urine at a cut-off of 300ng/ml. This product is used to obtain a visual, qualitative result.
This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the National Institute on Drug Abuse (NIDA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
Derived from leaves of coca plant, cocaine is a potent central nervous system stimulant and a local anesthetic. Among the psychological effects induced by using cocaine are euphoria, confidence and a sense of increased energy, accompanied by increased heart rate, dilation of the pupils, fever, tremors and sweating. Cocaine is excreted in urine primarily as benzoylecgonine in a short period of time. Benzoylecgonine has a biological half-life of 5 to 8 hours, which is much longer than that of cocaine (0.5 to 1.5 hour), and can be generally detected for 24 to 60 hours after cocaine use.
Urine based screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method for screening urine for drugs of abuse. The One-Step Cocaine Test is based on the principle of the highly specific immunochemical reactions of antigens and antibodies which are used for the analysis of specific compounds in biological fluids. This test is a rapid, visual, competitive immunoassay that can be used for the qualitative detection of benzoylecgonine, the major metabolite of cocaine, in human urine.
The One-Step Cocaine Test is a one-step immunoassay in which a chemically labeled drug (drug conjugate) competes with the drug which may be present in urine for limited antibody binding sites. The test device contains a membrane strip which was pre-coated with drug conjugate on the test band. A colored anti-benzoylecgonine monoclonal antibody-colloidal gold conjugate pad is placed at the right end of the membrane. In the absence of drug in the urine, the solution of colored antibody-colloidal gold conjugate and urine moves upward, chromatographically by capillary action, across the membrane. This solution then migrates to the immobilized drug conjugate zone on the test band region. The colored antibody-colloidal gold conjugate then attaches to the drug conjugate to form a visible line as the antibody complexes with the drug conjugate. Therefore, the formation of a visible precipitant in the test zone occurs when the test urine is negative for the drug. When the drug is present in the urine, the drug/metabolite antigen competes with the drug conjugate on the test band region for the limited antibody sites on the antibody-colloidal gold conjugate. When a sufficient concentration of drug is present, it will fill the limited antibody concentration of drug is present. It will fill the limited antibody binding sites. This will prevent attachment of the colored antibody colloidal gold conjugate to the drug conjugate zone on the test band region. Therefore, absence of the color band on the test region indicates a positive result.
A control band that has a different antigen/antibody reaction is added to the immunochromatographic membrane strip at the control region (C ) to indicate that the test has performed properly. This control line should always appear, regardless of the presence of drug or metabolite. This means that negative urine will produce two colored bands, and positive urine will produce only one band. The presence of this colored band in the control region also serves as 1) verification that sufficient volume of sample has been added, and 2) that proper flow was obtained.
MATERIALS REQUIRED BUT NOT PROVIDED
Specimen collection container. Timer
STORAGE AND STABILITY
The test kit should be stored refrigerated or at room temperature 2-30℃(36-86°F). Each device should remain in its sealed pouch for the duration of the shelf life of two years.
FOR IN-VITRO DIAGNOSTIC USE.
Urine specimens may be potentially infectious. Proper handing and disposal methods should be established.
Avoid cross-contamination of urine samples by using a new specimen collection container and specimen pipette for each urine sample.
SPECIMEN COLLECTION AND HANDLING
The One-Step Cocaine Test is formulated for use with urine specimens. Fresh urine does not require any special handing or pretreatment. Urine samples should be collected such that testing may be performed as soon as possible after the specimen collection, preferably during the same day. The specimen may be refrigerated at 2-8℃ for 3 days or frozen at -20℃ for a longer period of time. Specimens that have been refrigerated must be equilibrated to room temperature prior to testing. Specimens previously frozen must be thawed, equilibrated to room temperature, and mixed thoroughly prior to testing.
INTERPRETATION OF RESULTS
Positive: Only one pink band appears on test region of the Cassette.
Negative: Two pink bands appear on test region of the Cassette.
Invalid: If without colored band appears on test region, this is an indication of a possible error in performing the test. The test should be repeated using a new device.
LIMITATIONS OF PROCEDURE
1.The assay is designed for use with human urine only.
2.A positive result with the tests indicates the presence of a drug/metabolite only and does not indicate or measure intoxication.
3.There is a possibility that technical and/or procedural errors as well as other substances or factors not listed may interfere with the test and cause false results. See SPECIFICITY for lists of substances that will produce positive result, or that do not interfere with test performance.
4.If it is suspected that the samples have been mislabeled or tampered with, a new specimen should be collected and the test should be repeated.
The precision of the One-Step Cocaine Test was determined by conducting the test with spiked controls. The control at 150ng/ml gave negative results and the control at 450ng/ml gave positive results.
The specificity for the One-Step Cocaine Test was tested by adding various drugs, drug metabolites, and other compounds that are likely to be present in urine. All compounds were prepared in drug-free normal human urine.
The following compounds were tested for cross-reactivity in the One-Step Cocaine Test and found to be positives if the levels were greater than 300ng/ml.
Benzoylecgonine Cocaine Cocaine
The following compounds were found not be cross-react when tested at concentrations up to 100 ug/ml.