Urine Nonbenzodiazepine Hypnotic Agent ZOP Zopiclone Rapid Test 3mm STRIP

Product Specification

Drug Abuse Test Kit Zopiclone Rapid Test 3mm strip ,high sensitivity cut-off 50ng/ml

Product Name

ZOP ( Zopiclone) Rapid Diagnostic Test

Specimen: Urine

Background

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 may be measured in blood, plasma, or urine by chromatographic methods. Plasma concentrations are typically less than100 μg/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. Post mortem blood concentrations are usually in a range of 0.4-3.9 mg/l in victims of fatal acute overdose.2.3.4

The ZOP Rapid Test Panel (Urine) detects Zopiclone and/ or Zopiclone-N-oxide in urine at a cut-off concentration of 50ng/ml.

Test Principle

The TRO 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. Tropicamide, 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 Tropicamide-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 Tropicamide level exceeds the cut-off level, because it will saturate all the binding sites of anti- Tropicamide 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.

SPECIMEN COLLECTION AND STORAGE

The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used. Urine specimens exhibiting visible particles should be centrifuged, filtered, or allowed to settle to obtain clear specimen for testing. Specimen.

Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For long-term storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed before testing.

STORAGE

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.

LIMITATION

1. The 6-MAM Rapid Test Cassette provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrophotometry (GC/MS) is the preferred confirmatory method2.3.

2. It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.

3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.

4. A positive result indicates presence of the drug or its metabolites but does not indicate level of intoxication, administration route or concentration in urine.

5. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of the test.

performance characteristics

A side-by-side comparison was conducted using the Rapid Test Cassette (Urine) and GC/MS. The following results were tabulated: