Description

The Cortez Diagnostics, Inc. Opiates RapiDip™ Rapid Test is an immunochromatography based one
step in vitro test. It is designed for qualitative determination of Opiates and its metabolite in human urine specimens. The presence of morphine in human urine above a cut-off level of 300 ng/ml can be detected. This assay has not been evaluated in the point of care location and is for use by Healthcare Professionals only. SAMHSA recommends a cut-off concentration of 2000 ng/ml for Opiates Test.

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.

Opioid analgesics comprised of a large group of substances that control pain by depressing the central nervous system. Acute high dose used by abusers or addicts can cause depressed coordination, disrupted decision, decreased respiration, hypothermia and coma. Morphine is excreted non-metabolized and is the marker metabolic product of opiates. Morphine and morphine glucuronide is detectable in urine for several days after opiates dose. 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. Opiates 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 morphine-dye conjugate and free morphine which may be present in the urine specimen being tested. When morphine is present in the urine specimen, it competes with morphine-dye conjugate for the limited amount of anti-morphine antibody which is immobilized on the nitrocellulose membrane. When the amount of morphine is equal or more than the cutoff, 300 ng/ml, it will prevent the binding of morphine-dye 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.