MTZ Rapid Test Cassette(Urine), Desmethylmirtazapine , Rapid
Urine-Screening Test
| Principle | Chromatographic Immunoassay |
| Format | Dipstick, Cassette, Panel |
| Specimen | Urine |
| Certificate | CE |
| Reading Time | 5 minutes |
| Pack | 40T/50T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | 93.30% |
| Specificity | 95.60% |
| Accuracy | 94.90% |
| Cut-Off | 500 ng/mL |
MTZ Rapid Test Cassette(Urine), Desmethylmirtazapine , rapid
urine-screening test
A rapid test for the qualitative detection of Desmethylmirtazapine
in human urine. For professional in vitro diagnostic use only.
INTENDED USE
The MTZ Rapid Test Cassette (Urine) is a rapid chromatographic
immunoassay for the detection of Desmethylmirtazapine in urine at a cut-off
concentration of 500 ng/ml. This test will detect other related compounds, please refer to the
Analytical Specificity table in this 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) 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
Desmethylmirtazapine is a norepinephrine and specific serotonin
antidepressant, which can act on central presynaptic α2 receptor antagonist and enhance
adrenergic nerve conduction.1 The drug has been used clinically since 1990s as an
antidepressants. The effective dose for adults is usually 15-45 mg/d. Adverse reactions
include increased appetite, weight gain, sedationdizziness, somnolence, nausea,
orthostatic hypotension,and mania. A single labeled oral Desmethylmirtazapine
dose is eliminated in urine (85%) and feces (15%) over a one week period.The MTZ Rapid Test Cassette (Urine) 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 Desmethylmirtazapine in urine. The MTZ
Rapid Test Cassette (Urine) yields a positive result when the Desmethylmirtazapine in
urine exceed the cut-off level.
PRINCIPLE
The MTZ Rapid Test Cassette (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.
REAGENTS
The test contains mouse monoclonal anti-desmethylmirtazapine
antibody coupled particles and Desmethylmirtazapine-protein conjugate. A goat
antibody is employed in the control line system.
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 to room temperature before opening it. Remove
the test cassette from
the sealed pouch and use it within one hour
2. Place the cassette on a clean and level surface. Hold the
dropper vertically and transfer
3 full drops of urine (approx. 120 µl) to the specimen well(S) of
the cassette, and then start the timer. Avoid trapping air bubbles in the specimen
well(S).
3. 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
EXPECTED VALUES
This negative result indicates that the Desmethylmirtazapine
concentration is below the detectable level of 500 ng/ml. Positive result means the
concentration of Desmethylmirtazapine is above the level of 500 ng/ml. The MTZ Rapid
Test Cassette (Urine) has a sensitivity of 500 ng/ml.
Order Information
| Cat. No. | Product | Specimen | Pack |
| DMTZ-102 | MTZ Rapid Test Cassette | Urine | 40T |
| DMTZ-114 | MTZ Rapid Test Panel | Urine | 40T |
| DMTZ-101/111 | MTZ Rapid Test Dipstick | Urine | 50T |
