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This device is a one-step immunoassay intended to provide qualitative rapid detection of tricyclic antidepressants (TCA) at a cutoff level of 1000 ng/ml in human urine. It is for health care professional use only. It is for health care professional, in-vitro diagnostic use only. This device is a one-step immunoassay intended to provide qualitative rapid detection of tricyclic antidepressants (TCA) at a cutoff concentration of 1,000 ng/ml in human urine. It is for health care professional use only. Instant-View™ TCA Urine Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) 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 used.

A one-step lateral flow chromatographic immunoassay. The test strip in the device includes 1) a conjugate pad containing colloidal gold coupled with mouse anti-TCA antibodies; 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The Test line is coated with TCA- BSA, and the Control line is coated with goat anti-mouse IgG antibody.