Description

Cortez Diagnostics, Inc. TCA RapiCard™ Rapid Test is a one-step immunoassay intended to provide qualitative rapid detection of tricyclic antidepressants (TCA) at a cutoff concentration of 1000 ng/ml in human urine. It is for health care professional use only.

This assay provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly
when preliminary positive results are obtained.

Tricyclic Antidepressants (TCA) are a group of antidepressant drugs that contain three fused rings in their chemical structure. TCA can be taken orally or intramuscularly (IM). The progressive symptomatology of TCA includes agitation, confusion, hallucinations, hypertonicity, seizures, and EKG changes. The half-life of TCA varies from few hours to few days. The commonly used tricyclic antidepressants are excreted with a very low percentage of unchanged drugs in the urine, less than 1%. Therefore, detecting TCA or metabolites of TCA in human urine has been used for screening the abuse of TCA. This test is able to detect amitriptyline, desipramine, imipramine and nortriptyline at a cut off level of 1,000 ng/ml.

The Cortez Diagnostics, Inc. TCA RapiCard™ Rapid Test is a one-step lateral flow chromatographic immunoassay. The test strip includes 1) a burgundy-colored conjugate pad containing mouse anti-TCA antibodies coupled to colloidal gold (the immunogen is a blend of amitriptyline, desipramine, imipramine and nortriptyline); and 2) nitrocellulose
membrane containing a Test (T) line and a Control (C) line. The Test line is coated with TCA-BSA, and the Control line is coated with goat anti-rabbit IgG antibody. Cortez TCA Test is a competitive binding immunoassay. The TCA and or TCA metabolites in the urine specimen compete with the TCA-BSA coated on the nitrocellulose membrane for the limited binding sites of the conjugated anti-TCA
antibodies. When an adequate amount of urine specimen is applied to the sample pad of the device, the urine specimen migrates by capillary action through the test strip. If the level of TCA and/or TCA metabolites in the urine specimen is below the cutoff (1,000 ng/ml), the Test line appears as a visible burgundy line. If the level of TCA and/or TCA metabolites in the urine specimen is at or above the cutoff, no Test line develops. The C line binds to the gold-conjugated rabbit IgG and forms a burgundy color line, regardless of the presence of TCA metabolites.