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For healthcare professionals including professionals at point of care sites.
For in vitro diagnostic use only.
Format: Strip, Cassette, Cup,and Panel
The PCP One Step Phencyclidine Test Strip is a lateral flow chromatographic immunoassay for the detection of Phencyclidine in urine at a cut-off concentration of 25 ng/mL.
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.
The PCP One Step Phencyclidine Test Strip is an immunoassay based on the principle of competitive binding. Drugs that 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 the antibody in the test strip. The Phencyclidine conjugate will be captured by antibody 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 25 ng/mL because it will saturate all the binding sites of anti-Phencyclidine antibodies.
A drug-positive urine specimen will not generate a colored line in the test line region (T) because of drug competition, while a drug-negative urine specimen will generate a line in the test line region because of the absence of drug competition.
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.
NOTE: The shade of the color in the test line region (T) will vary, but it should be considered negative whenever there is even a faint line.
POSITIVE: One colored line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the Phencyclidine concentration exceeds the detectable level (25 ng/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 strip. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
Contact Person: Ms. Anna Lee