Description

The Cortez Diagnostics, Inc. Barbiturates RapiDip™ Rapid Test is an immunochromatography based one step in vitro test. It is designed for qualitative determination of barbiturates and their metabolites in human urine specimens above a cut-off level of 300 ng/ml of secobarbital. 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.

Barbiturates are a group of prescription drugs that are frequently abused. They can depress the central nervous system. Acute higher dose induces exhilaration, sedation and respiratory depression. More acute responses produce respiratory collapse and coma. The effects of short-acting barbiturates such as secobarbital last 3 to 6 hours. The effects of long-acting barbiturates such as phenobarbital last 10
to 20 hours. Short-acting barbiturates normally remain detectable in urine for 4 to 6 days, while long acting barbiturates can be detected for up to 30 days. Barbiturates are excreted in the urine in unchanged forms, hydroxylated derivatives, carboxylated derivatives and glucuronide conjugates.

The Cortez Diagnostics, Inc. Barbiturates RapiDip™ Rapid Test 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, 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.