The MTZ Rapid Test Dipstick (Urine) is an 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. Desmethylmirtazapine, if present in the urine specimen
below the cut-off level, will not saturate the binding sites of the
antibody in the test. The antibody coated particles will then be
captured by immobilized Desmethylmirtazapine-protein 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 Desmethylmirtazapine level exceeds the cut-off level, because
it will saturate all the binding sites of anti-desmethylmirtazapine antibody. 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.
DIRECTIONS FOR USE
Allow the test, urine specimen, and/or controls to reach room
temperature (15-30 °C) prior to testing.
1. Bring the pouch or canister to room temperature before opening
it. Remove the test dipstick from the sealed pouch or closed
canister and use it within one hour.
2. With the arrow pointing toward the urine specimen, immerse the
test dipstick vertically in the urine specimen in such a way that
urine does not cross MAX line on the test Dipstick for 10-15
seconds. See the illustration below.
3. Place the Test Dipstick on a non-absorbent flat surface, start
the timer and wait for the colored line(s) to appear. Read results
at 5 minutes. Do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* Two colored lines appear. One colored line should be in
the control line region (C), and another colored line should be in
the test line region (T). This negative result indicates that the
Desmethylmirtazapine concentration is below the detectable cut-off
level.
*NOTE: The shade of color in the test line region (T) may vary, but
it should be considered negative whenever there is even a faint
colored line.
POSITIVE: One colored line appears in the control line region (C).
No line appears in the test line region (T). This positive result
indicates that the Desmethylmirtazapine concentration exceeds the
detectable cut-off 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 with
a new test. If the problem persists, discontinue using the test kit
immediately and contact local distributor.
