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.
