A rapid, one step test for the qualitative detection of Tricyclic Antidepressants in human urine.

For healthcare professionals including professionals at point of care sites.

For in vitro diagnostic use only.

MOR/MET/THC/AMP/MDMA/MTD/COC/TCA/BAR/BZO, up to 15 kinds of Drug Tests

Format: Strip, Cassette, Cup,and Panel 

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.

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.

 NOTE:  The shade of red in the test line region (T) will vary, but it should always be considered as negative whenever there is even a faint pink line.

POSITIVE: One red line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the Tricyclic Antidepressants concentration exceeds the detectable level.

INVALID:  Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test strip. If the problem persists, discontinue using the lot immediately and contact your local distributor.