COC Rapid Test Cassette (Urine), 300 Ng/ML., Coca/ine Metabolite, Benzoylecgonine,
|Dipstick, Cassette, Panel, Device, Cup
|100 ng/mL, 150 ng/mL, 300 ng/mL*,20 ng/mL* ,50 ng/mL,0.5 ng/mg
COC Rapid Test Cassette (Urine), 300 ng/mL., Coc/aine metabolite, Benzoylecgonine
A rapid test for the qualitative detection of Coca/ine metabolite in human urine.
For professional in vitro diagnostic use only.
The COC Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Coc/aine metabolite, Benzoylecgonine, in human urine at a cut-off concentration of 300 ng/mL. This test will detect other related compounds, please refer to the Analytical Specificity table in this package insert.
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.
Coc/aine 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 pasms. In large amounts, Co/caine causes fever, unresponsiveness, and difficulty in breathing and unconsciousness. Cocai/ne 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. Benzoylecgonine, a major metabolite of Coca/ine, has a longer biological half-life (5 - 8 hours) than Cocain/e (0.5 - 1.5 hours), and can generally be detected for 24-48 hours after Coca/ine exposure. The COC (Coc/aine) Test Cassette 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 Coca/ine metabolite in urine. The COC Rapid Test Cassette yields a positive result when the Coc/aine metabolite in urine exceeds 300ng/ml. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA).
The COC Rapid Test Cassette 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 300ng/ml, will not saturate the binding sites of antibody in the test. 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 is above 300ng/ml because it will saturate all the binding sites of antibodies.
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.
The test contains mouse monoclonal anti-Benzoylecgonine antibody-coupled particles and Benzoylecgonine-protein conjugate. A goat antibody is employed in the control line system.
Please read all the information in this package insert before performing the test.
For medical and other professional in vitro diagnostic use only. Do not use after the exp. date.
The test 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.
The used test should be discarded according to local regulations.
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
DIRECTIONS FOR USE
Allow the test, urine specimen, and/or controls to reach room temperature (15-30ºC) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the cassette from the sealed pouch and use it within one hour.
2. Place the cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 120ul) to the specimen well of the cassette, and then start the timer. Avoid trapping air bubbles in the specimen well. See illustration below.
3. Wait for the color line(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* Two lines appear. One color line should be in the control region (C), and another apparent color line should be in the test region (T). This negative result indicates that the Benzoylecgonine concentration is below the detectable level of 300ng/ml.
*NOTE: The shade of color in the test region (T) may vary, but it should be considered negative whenever there is even a faint color line.
POSITIVE: One color line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the Benzoylecgonine concentration is above the detectable level of 300ng/ml.
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 Cassette. If the problem persists, discontinue using the Test Cassette immediately and contact your local distributor.
A procedural control is included in the test. A color line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume and correct procedural technique.
Control standards are not supplied with this Test Cassette; however it is recommended that positive and negative controls be tested as good laboratory testing practices to confirm the test procedure and to verify proper test performance.
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