Drug test MDMA Rapid test strip,4mm strip detecting Ecstasy in urine, Quickly, Gold colloidal method


Intended Use


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 (Urine) 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 (Urine) yields a positive result when the Cocaine metabolite in urine exceeds 300 ng/mL.

Test Principle


The COC One Step Cocaine Test Strip (Urine) is a rapid chromatographic 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-coated particles in the test strip. The antibody-coated particles will then be captured by immobilized Benzoylecgonine conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the Benzoylecgonine level exceeds 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, while a drug-negative urine specimen or a specimen containing a drug in a concentration less than the cut-off will generate a colored 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.



DIRECTIONS FOR USE


Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.
Using the provided disposable pipette, transfer 3 drops of specimen (approximately 120 µL) to the specimen well (S) of the device and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate across the membrane.
Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 8 minutes

INTERPRETATION OF RESULTS


(Please refer to the illustration above)
NEGATIVE:* A colored line appears in the Control region (C) and colored lines appears in the Test region (T). This negative result means that the concentrations in the urine sample are below the designated cut-off levels for a particular drug tested.
*NOTE: The shade of the colored lines(s) in the Test region (T) may vary. The result should be considered negative whenever there is even a faint line.
POSITIVE: A colored line appears in the Control region (C) and NO line appears in the Test region (T). The positive result means that the drug concentration in the urine sample is greater than the designated cut-off for a specific drug.
INVALID: No line appears in the Control region (C). Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for Control line failure. Read the directions again and repeat the test with a new test card. If the result is still invalid, contact your manufacturer.


QUALITY CONTROL


A procedural control is included in the test. A line appearing in the control region
(C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.
Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.

Performance characteristics


Analytical Sensitivity

A drug-free urine pool was spiked with Cocaine at the following concentrations: 0ng/mL, 150ng/mL, 225ng/mL, 300ng/mL, 375ng/mL, 450ng/mL and 600mg/ml. The result demonstrates > 99% accuracy at 50% above and 50% below the cut-off concentration. Results are presented in Table 2 below.

Table 2: Analytical Sensitivity Summary

Conclusion: As indicated in table above: all specimens with COC concentration equal to or lower than 150ng/mL show negative results, all specimens with COC concentration of 300ng/mL are identified as “+/-”, and all specimens with COC concentration equal to or higher than 450ng/mL showed positive results. Therefore, the cut-off concentration of the COC One Step Test Strip (Urine) is determined to be 300ng/mL COC.

Analytical Specificity

Table 3 lists the compounds that are positively detected in urine by the COC One Step Cocaine Test Strip (Urine) at 5 minutes and the concentrations at which they are detected.

Table 3: Analytical Specificity