Description

The Cortez Diagnostics, Inc. Cocaine RapiDip™ Rapid Test is an immunochromatography based one
step in vitro test. It is designed for qualitative determination of Cocaine’s metabolite, benzoylecgonine in human urine specimens above a cut-off level of 300 ng/ml. 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.


Derived from the leaves of cocoa plant, cocaine is a potent central nervous system stimulant as well as a local anesthetic. Some of the psychological effects induced by cocaine are: euphoria, confidence and a
sense of increased energy, accompanied by increased heart rate, dilation of the pupils, fever, tremors and sweating. Continued ingestion of cocaine could induce tolerances and physiological dependency which leads to its abuse. Cocaine is used by smoking, intravenous, intranasal or oral administration and excreted in the urine primarily as benzoylecgonine in a short period.
Benzoylecgonine has a biological half-life of 5 – 8 hours, which is much longer than that of cocaine (0.5 – 1.5 hours), and can be generally detected for 12 – 72 hours after cocaine use or exposure. 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. Cocaine 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, 300 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.