Description

The Cortez Diagnostics, Inc. THC RapiDip™ Rapid Test is an immunochromatography based one step in vitro test. It is designed for qualitative determination of THC and its metabolites in human urine specimens. The
presence of 11-nor-Δ9-THC-9-COOH in human urine above a cut-off level of 50 ng/ml can be detected. This assay may be used 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.

The agents of Marijuana that cause various biological effects in humans are called cannabinoids. Cannabinoids are central nervous stimulants that alter mood and sensory perceptions, produce loss of coordination, impair short term memory, produce symptoms of anxiety, paranoia, depression, confusion,
hallucination, and increased heart rate. Large doses of cannabinoid could cause the development of tolerances and physiological dependency and lead to abuse. A tolerance to the cardiac and psychotropic effects can occur and withdrawal syndrome produces restlessness, insomnia, anorexia and nausea. Δ9-THC is the primary active ingredient in cannabinoids. The main metabolite excreted in the urine is 11-nor-Δ9-THC-9-COOH, which are found within hours of exposure and remain detectable in the urine for 3-10 days after smoking. 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. THC 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, 50 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.