MTZ Rapid Test Panel(Urine), Desmethylmirtazapine detect, Drug
Abuse Test Kit
A rapid test for the qualitative detection of Desmethylmirtazapine
in human urine. For professional in vitro diagnostic use only.
| Product: | MTZ Rapid Test Panel(Urine), Desmethylmirtazapine Detect, Drug
Abuse Test Kit |
| Principle: | Chromatographic Immunoassay |
| Specimen: | Urine |
| Reading Time: | 5 Minutes |
| Storage Temperature: | 2-30°C |
| Sensitivity: | 93.30% |
| Accuracy: | 94.90% |
| Cat No.: | DMTZ-114 |
| Format: | Panel |
| Certificate: | CE |
| Pack: | 40T/50T |
| Shelf Life: | 2 Years |
| Specificity: | 95.60% |
| Cut-Off: | 500 Ng/mL |
INTENDED USE
The MTZ Rapid Test Panel (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 Panel (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 Panel (Urine) yields a positive result when the Desmethylmirtazapine in
urine exceed the cut-off level.
PRINCIPLE
The MTZ Rapid Test Panel (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.
PRECAUTIONS
• For professional in vitro diagnostic use only.
• Do not use after the expiration date.
• The test 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 should be discarded according to local regulations.
DIRECTIONS FOR USE
Allow the test, urine specimen, and/or controls to reach room
temperature (15-30 °C) prior to testing.
1. Remove the test panel from the sealed pouch and use it as soon
as possible.
2. Remove the cap.
3. With the arrow pointing toward the urine specimen, immerse the
test panel vertically in the urine specimen for at least 10 to 15
seconds. Immerse the strip to at least the level of the wavy lines,
but do not touch the plastic device.
4. Replace the cap and place the test panel on a non-absorbent flat
surface.
5. Start the timer and wait for the colored line(s) to appear.
6. Read result 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 when 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 your local distributor.
| Cat. No. | Product | Specimen | Pack | Cut-Off |
| DMTZ-102 | MTZ Rapid Test Cassette | Urine | 40T | 500 ng/mL |
| DMTZ-114 | MTZ Rapid Test Panel | Urine | 40T | 500 ng/mL |
| DMTZ-101/111 | MTZ Rapid Test Dipstick | Urine | 50T | 500 ng/mL |
