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:
| Zopiclone Concentration | Percent of Cut-off | n | Visual Result |
| (ng/ml) | | | Negative | Positive |
| 0 | 0 | 30 | 30 | 0 |
| 25 | -50% | 30 | 30 | 0 |
| 37.5 | -25% | 30 | 27 | 3 |
| 50 | Cut-off | 30 | 17 | 13 |
| 62.5 | +25% | 30 | 4 | 26 |
| 75 | +50% | 30 | 0 | 30 |
| 150 | 3X | 30 | 0 | 30 |
| Analytical | Specificity | | |
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
