INTENDED USE

The TCA One Step Tricyclic Antidepressants Test Strip (Urine) is a lateral flow chromatographic immunoassay for the detection of Nortriptyline at a cut-off concentration of 1000 ng/mL. This test will detect other Tricyclic Antidepressants. Please refer to the Analytical Specificity table in the package insert.

This assay provides only a qualitative, 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) 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 used.

SUMMARY

TCA (Tricyclic Antidepressants) are commonly used for the treatment of depressive disorders. TCA overdoses can result in profound central nervous system depression, cardiotoxicity and anticholinergic effects. TCA overdose is the most common cause of death from prescription drugs. TCAs are taken orally or sometimes by injection. TCAs are metabolized in the liver. Both TCAs and their metabolites are excreted in urine mostly in the form of metabolites for up to ten days.

The TCA One Step Tricyclic Antidepressants Test Strip is a rapid urine-screening test that can be performed without the use of an instrument. The test utilizes the antibody to selectively detect elevated levels of Tricyclic Antidepressants in urine. The TCA One Step Tricyclic Antidepressants Test Strip yields a positive result when the Tricyclic Antidepressant in urine exceeds cut-off concentration.

PRINCIPLE

The TCA One Step Tricyclic Antidepressants Test Strip (Urine) is a rapid chromatographic immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.

During testing, a urine specimen migrates upward by capillary action. Tricyclic Antidepressants, if present in the urine specimen below the cutoff level, will not saturate the binding sites of the antibody in the test strip. The antibodies will then be captured by immobilized Tricyclic Antidepressants conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the Tricyclic Antidepressants level exceeds the cutoff level because it will saturate all the binding sites of anti-Tricyclic Antidepressants antibodies.

A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

REAGENTS

The test contains a membrane strip coated with drug-protein conjugate on the test line, goat anti-rabbit IgG antibody on the control line, a dye pad which contains colloidal gold particles coated with mouse monoclonal antibody specific to Tricyclic Antidepressants.

PRECAUTIONS

·    For healthcare professionals including professionals at point of care sites.

·    For in vitro diagnostic use only. Do not use after the expiration date.

·    The test strip should remain in the sealed pouch until use.

·    All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

·    The used test strip should be discarded according to federal, state and local regulations.

STORAGE AND STABILITY

Store as packaged in the sealed pouch at 2-30°C. The test strip is stable through the expiration date printed on the sealed pouch. The test strips must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.