Description

The Cortez Diagnostics, Inc. PCP RapiDip™ Rapid Test is an immunochromatography based one
step in vitro test. It is designed for qualitative determination of Phencyclidine in human urine specimens above a cut-off level of 25 ng/ml. This assay may be uesd in the point of care setting. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration(SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Phencyclidine, commonly known as PCP, is a hallucinogen which interacts with dopamine, cholinergic and adrenergic systems. It has dose dependent stimulant, depressant, hallucinogenic and psychological effects. PCP is mostly administered by oral or intravenously. Even moderate amount of PCP, from 5 to 100 ng/ml, can result in psychotic, violent and self-destruction. At high dose, from 100 to 500 ng/ml, PCP can cause convulsions, hypertion, and even death. PCP is metabolized via hydroxylation, oxidation, and conjugateion with glucuronic acid in the liver. About 10% of the dose is excreted in urine as unchanged drug. PCP can be detected in the urine for 7 to 8 days after drug administration. For chronic users, PCP may persist in urine for 2 to 4 weeks. However, the length of time following drug use for which a positive result may occur is dependent upon several factors, including the frequency and amount of drug, metabolic rate, excretion rate, drug half-life, and the drug user’s age, weight, activity, and diet.

The Cortez Diagnostics, Inc. PCP RapiDip™ Rapid Test is based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen. The assay relies on the competition for binding antibody between drug conjugate and free drug which may be present in the urine specimen being tested. When drug is present in the urine specimen, it competes with drug conjugate for the limited amount of antibody-dye conjugate. When the amount of drug is equal or more than the cut-off, 25 ng/ml, it will prevent the binding of drug conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result. A control line is present in the test window to work as procedural control. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.