A rapid test for the qualitative detection of Zopiclone in human urine. For medical and other professional in vitro diagnostic use only.
INTENDED USE
The ZOP Rapid Test Cassette (Urine) is a rapid chromatographic immunoassay for the detection of Zopiclone in urine at a cut-off concentration of 50ng/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
Zopiclone is a nonbenzodiazepine hypnotic agent used in the treatment of insomnia. It is a cyclopyrrolone, which increases the normal transmission of the neurotransmitter gamma-aminobutyric acid in the central nervous system, as benzodiazepines do, but in a different way. Zopiclone is indicated for the short-term treatment of insomnia where sleep initiation or sleep maintenance are prominent symptoms. Long-term use is not recommended, as tolerance, dependence, and addiction can occur with prolonged use. Zopiclone is partly extensively metabolized in the liver to form an active N-demethylated derivative (N-desmethylzopiclone) and an inactive zopiclone-N-oxide.
In urine, the N-demethyl and N-oxide metabolites account for 30% of the initial dose. Between 7 and 10% of zopiclone is recovered from the urine, indicating extensive metabolism of the drug before excretion. The terminal elimination half-life of zopiclone ranges from 3.5 to 6.5 hours (5 hours on average).1 Time to peak plasma concentration is 1 - 2 h, the absorption rate constant is 1.3 h-1 and maximum plasma concentration after administration of 7.5 mg is 131µg/l. Zopiclone is recommended to be taken on a short-term basis, usually a week or less. Daily or continuous use of the drug is not usually advised.2 When taken alone, it usually is not fatal, but when mixed with alcohol or other drugs such as opioids, or in patients with respiratory, or hepatic disorders, the risk of a serious and fatal overdose increases.
Zopiclone may be measured in blood, plasma, or urine by chromatographic methods. Plasma concentrations are typically less than 100μg/l during therapeutic use, but frequently exceed 100μg/l in automotive vehicle operators arrested for impaired driving ability and may exceed 1000μg/l in acutely poisoned patients.
The ZOP Rapid Test Cassette (Urine) detects Zopiclone and/ or Zopiclone-N-oxide in urine at a cut-off concentration of 50ng/ml.
PRINCIPLE
The ZOP 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. Zopiclone, if present in the urine pecimen 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 Zopiclone-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 Zopiclone level exceeds the cut-off level, because it will saturate all the binding sites of anti-zopiclone 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-zopiclone antibody coupled particles and zopiclone-protein conjugate. A goat antibody is employed in the control line system.
PRECAUTIONS
- For medical and other 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.
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
DIRECTIONS FOR USE
Allow the test, urine specimen, and/or controls to reach room temperature (15-30ºC) 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 test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 120 uL) to the specimen well (S) of the test cassette, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration below.
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 lines appear. One colored line should be in the control line region (C), and another apparent colored line should be in the test line region (T). This negative result indicates that the Zopiclone (including metabolite) 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 zopiclone (including metabolite) 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.
Order Information
| Cat. No. | Product | Specimen | Pack |
| DZOP-102 | Zopiclone (ZOP) Rapid Test Cassette | Urine | 40T |
| DZOP-114 | Zopiclone(ZOP) Rapid Test Panel | Urine | 40 T |
| DZOP-101 | Zopiclone(ZOP) Rapid Test Dipstick | Urine | 50 T |
