Drug Abuse Test Kit PCP (Phencyclidine) Rapid Diagnostic Test strip, 25ng/ml cut-off urine drug test, professional use


Product Name


PCP Rapid Diagnostic Test/ Phencyclidine Rapid Diagnostic Test
Specimen: Urine


Intended Use


Phencyclidine, also known as PCP, is a hallucinogen that was first marketed as a surgical anesthetic in the 1950’s. It was removed from the market because patients receiving it became delirious and experienced hallucinations.Phencyclidine is used in powder, capsule, and tablet form. The powder is either snorted or smoked after mixing it with marijuana or vegetable matter. PCP is most commonly administered by inhalation but can be used intravenously, intra-nasally, and orally. After low doses, the user thinks and acts swiftly and experiences mood swings from euphoria to depression. Self-injurious behavior is one of the devastating effects of PCP.PCP can be found in urine within 4 to 6 hours after use and will remain in urine for 7 to 14 days, depending on factors such as metabolic rate, user’s age, weight, activity, and diet. PCP is excreted in the urine as unchanged drug (4% to 19%) and conjugated metabolites (25% to 30%).The PCP One Step Phencyclidine 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 Phencyclidine metabolite in urine. The PCP One Step Phencyclidine Test Strip (Urine) yields a positive result when the Phencyclidine metabolite in urine exceeds 25 ng/mL.

Test Principle

The PCP One Step Phencyclidine 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. Phencyclidine, if present in the urine specimen below 25 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 Phencyclidine 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 Phencyclidine level exceeds 25ng/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


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 Phencyclidine at the following concentrations: 0 ng/mL, 12.5 ng/mL, 18.75 ng/mL, 25 ng/mL, 31.25 ng/mL, 37.5ng/mL and 50ng/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 PCP concentration equal to or lower than 12.5ng/mL show negative results, all specimens with PCP concentration of 25ng/mL are identified as “+/-”, and all specimens with PCP concentration equal to or higher than 37.5ng/mL showed positive results. Therefore, the cut-off concentration of the PCP One Step Phencyclidine Test Strip (Urine) is determined to be 25ng/mL PCP.