Drug Abuse Test Kit Zopiclone Rapid Test 4mm cassette ,high sensitivity cut-off 50ng/ml
Product Name
ZOP ( Zopiclone) Rapid Diagnostic Test
Specimen: Urine
Intended Use
The ZOP Rapid Test Panel (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.
| Parameter | Calibrator | Cut-off (ng/mL) |
| ZOP | Zopiclone | 50 |
Test Principle
The ZOP 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. Zopiclone, 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 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-N-oxide 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.
DIRECTIONS FOR USE
Bring tests, specimens, and/or controls to room temperature
(15-30°C) before use.
Remove the test from its sealed pouch, and place it on a clean,
level surface. Label the test with patient or control
identification. For best results, the assay should be performed
within one hour.
Using the provided disposable pipette, transfer 3 drops of specimen
(approximately 120 µL) to the specimen well (S) of the device and
start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add
any solution to the result area.
As the test begins to work, color will migrate across the membrane.
Wait for the colored band(s) to appear. The result should be read
at 5 minutes. Do not interpret the result after 8 minutes
INTERPRETATION OF RESULTS
NEGATIVE:* A colored line appears in the Control region (C) and colored lines
appears in the Test region (T). This negative result means that the
concentrations in the urine sample are below the designated cut-off
levels for a particular drug tested.
*NOTE: The shade of the colored lines(s) in the Test region (T) may
vary. The result should be considered negative whenever there is
even a faint line.
POSITIVE: A colored line appears in the Control region (C) and NO line
appears in the Test region (T). The positive result means that the
drug concentration in the urine sample is greater than the
designated cut-off for a specific drug.
INVALID: No line appears in the Control region (C). Insufficient specimen
volume or incorrect procedural techniques are the most likely
reasons for Control line failure. Read the directions again and
repeat the test with a new test card. If the result is still
invalid, contact your manufacturer.
QUALITY CONTROL
A procedural control is included in the test. A colored line
appearing in the control line region (C) is considered an internal
procedural control. It confirms sufficient specimen volume,
adequate membrane wicking and correct procedural technique.
performance characteristics
A side-by-side comparison was conducted using the Rapid Test
Cassette (Urine) and GC/MS. The following results were tabulated:
Table 1: Specimen Correlation
     Method | | | GC/MS | Total Results |
| | Results | Positive | Negative | |
| ZOP Rapid Test Panel | | Positive | 19 | 2 | 21 |
| | Negative | 3 | 69 | 72 |
| Total Results | | | 22 | 71 | 93 |
| % Agreement | | 86.4% | 97.2% | 94.6% |
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
