COC Rapid Test Cassette (Urine), Coc/aine Metabolite, Benzoylecgonine Detection, CE/FDA
A rapid test for the qualitative detection of Coc/aine metabolite in human urine.
For professional in vitro diagnostic use only.
| Principle |
Chromatographic Immunoassay |
| Format |
Dipstick, Cassette, Panel, Device, Cup |
| Specimen |
Urine,Oral Fluid,Powder,WB/S/P,Hair |
| Certificate |
CE/FDA |
| Reading Time |
5 minutes |
| Pack |
10T/25T/40T/50T |
| Storage Temperature |
2-30°C |
| Shelf Life |
2 Years |
| Sensitivity |
97.80% |
| Accuracy |
98.00% |
| Cut-Off |
100 ng/mL, 150 ng/mL, 300 ng/mL*,20 ng/mL* ,50 ng/mL,0.5 ng/mg |
INTENDED USE
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.
SUMMARY
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 spasms. In large amounts, Coc/aine causes fever, unresponsiveness, and difficulty in breathing and unconsciousness. Coc/aine 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 Coc/aine, has a longer biological half-life (5 - 8 hours) than Coc/aine (0.5 - 1.5 hours), and can generally be detected for 24-48 hours after Coc/aine 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 Coc/aine 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).
PRINCIPLE
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.
REAGENTS
The test contains mouse monoclonal anti-Benzoylecgonine antibody-coupled particles and Benzoylecgonine-protein conjugate. A goat antibody is employed in the control line system.
PRECAUTIONS
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.
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. 120µl) 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.
QUALITY CONTROL
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.
Coc/aine: A Deadly Surge We Can't Ignore
In recent years, there has been a concerning global trend of rising coc/aine usage, with the frequency of its use increasing across countries and continents. This escalation is alarming as it signifies the growing demand and availability of this highly addictive and hazardous substance.
The recently published United Nations 2023 Global Report on Coc/aine sheds light on the troubling state of coc/aine use in Canada. The report reveals that approximately half a million Canadians admitted to using coc/aine in 2022, indicating its widespread prevalence within the country. Additionally, the report highlights the lower retail price of coc/aine in Canada compared to many other nations, indicating its high accessibility.
The widespread use of coc/aine poses significant risks to individuals and communities. Its addictive nature, coupled with its availability and affordability, contributes to the rising number of drug-related deaths. Moreover, coc/aine abuse can result in various health complications, including cardiovascular issues, mental health disorders, and an increased likelihood of engaging in risky behaviors.
To address the increasing prevalence of coc/aine use, a comprehensive and multifaceted approach is necessary. This approach involves robust law enforcement measures to disrupt the drug supply chain, targeted prevention programs that educate the public about the risks and consequences of coc/aine use, and accessible treatment and rehabilitation services for individuals struggling with addiction.
