A rapid, one step test for the qualitative detection of Tricyclic Antidepressants in human urine.
For healthcare professionals including professionals at point of
For in vitro diagnostic use only.
Format: Strip, Cassette, Cup,and Panel
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.
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
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.
Contact Rebecca Yan