MTZ Rapid Test Dipstick Urine specimen, Desmethylmirtazapine detect, Drug Abuse Test Kit
| Product: |
MTZ Rapid Test Dipstick Urine Specimen, 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-101/111 |
| Format: |
Cassette |
| Certificate: |
CE |
| Pack: |
40T/50T |
| Shelf Life: |
2 Years |
| Specificity: |
95.60% |
| Cut-Off: |
500 Ng/mL |
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 Dipstick (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.
PRINCIPLE
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.
