A rapid test for the qualitative detection of Zaleplon in human
urine. For medical and other professional in vitro diagnostic use only.
| Principle | Chromatographic Immunoassay |
| Format | Dipstick, Cassette, Panel, Cup |
| Specimen | Urine |
| Certificate | CE |
| Reading Time | 5 minutes |
| Pack | 40T/50T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | 95.20% |
| Specificity | 97.40% |
| Accuracy | 96.70% |
| Cut-Off | 100 ng/mL |
INTENDED USE
The ZAL Rapid Test Cassette (Urine) is a rapid
immunochromatographic assay for the qualitative detection of Zaleplon (ZAL) at a cut-off concentration of 100 ng/mL.
This assay provides only a 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
Zaleplon is a sedative-hypnotic, almost entirely used for the
management/treatment of insomnia. It is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class1. Zaleplon has a pharmacological profile similar to benzodiazepines,
characterized by an increase in slow wave deep sleep (SWDS) with rapid onset of hypnotic action.
Zaleplon is a full agonist for the benzodiazepine α1 receptor located on the GABAA receptor complex in
the body, with lower affinity for the α2 and α3 subsites. It selectively enhances the action of GABA similar
to, but more selectively than benzodiazepines. Zaleplon, although not a benzodiazepine, maintains
a very similar chemical structure nonetheless, known for inducing hypnotic effects by α1 subreceptor
sites, anxiolytic and muscle relaxant effects via α2 and α3 subsites, with negligible anticonvulsant
properties (via α5 subsite), as zaleplon action is modulated at benzodiazepine receptor sites. The elimination
half-life of zaleplon is about 1–1.5 hours.
The absorption rate of zaleplon is rapid and the onset of therapeutic
effects is typically breached within 5–15 minutes following ingestion.Zaleplon is primarily metabolised by
aldehyde oxidase, and its half-life can be affected by substances which inhibit or induce aldehyde oxidase.
Taken orally, zaleplon reaches full concentration in about one hour. It is extensively metabolised into
5-oxozaleplon and 5-oxodesethylzaleplon (the latter via desethylzaleplon), with less than 1% of it excreted
intact in urine.
The ZAL Rapid Test Cassette (Urine) is a rapid urine screening test
that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to
selectively detect elevated levels of ZAL in urine. The ZAL Rapid Test Cassette (Urine) yields a positive result when
ZAL in urine exceeds 100ng/ml.
PRINCIPLE
The ZAL 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. ZAL, if present in the urine specimen below 100ng/ml, will not saturate the binding sites of
antibody-coated particles in the test device. The antibody-coated particles will then be captured by immobilized
ZAL-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 ZAL level exceeds 100ng/ml because it will saturate all the binding sites of
anti-Zaleplon antibodies.
A drug-positive urine specimen will not generate a colored line in
the test line region, 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 cassette contains mouse monoclonal anti- Zaleplon
antibody-coupled particles and ZAL-proteinconjugate. 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 cassette 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 10minutes.
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 apparent colored line should be in the test line region
(T). A negative result indicates that the ZAL concentration is below the detectable level (100ng/ml).
*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). A positive result indicates that the ZAL concentration exceeds
the detectable level (100ng/ml).
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 using a new test. If the problem persists, discontinue using the lot immediately and
contact your local distributor.
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.
Control standards are not supplied with this kit; however, it is
recommended that positive and negative controls be tested as good laboratory testing practice to confirm
the test procedure and to verify proper test performance.
Order Information
| Cat. No. | Product | Specimen | Pack |
| DZAL-102 | Zaleplon (ZAL) Rapid Test Cassette | Urine | 40T |
| DZAL-114 | Zaleplon(ZAL) Rapid Test Panel | Urine | 40 T |
| DZAL-101 | Zaleplon(ZAL) Rapid Test Dipstick | Urine | 50 T |
