ALP Rapid Test Cassette (Urine), 100ng/m cut-off, detection of
alprazolam, Xanax
A rapid test for the qualitative detection of Alprazolam 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 | 90.90% |
| Specificity | 97.40% |
| Accuracy | 95.90% |
| Cut-Off | 100 ng/mL* |
INTENDED USE
The ALP Rapid Test Cassette (Urine) is a rapid chromatographic
immunoassay for the detection of alprazolam in urine at a cut-off concentration of 100ng/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
Alprazolam, available under the trade name Xanax among others, is a
short-acting anxiolytic of the benzodiazepine class. It is commonly used for the treatment of
panic disorder, and anxiety disorders, such as generalized anxiety disorder (GAD) or social anxiety disorder
(SAD).1,2 Alprazolam, like other benzodiazepines, binds to specific sites on the GABAA receptor. It
possesses anxiolytic, sedative, hypnotic, skeletal muscle relaxant, anticonvulsant, and amnestic
properties.
A mean half-life of alprazolam of 16.3 hours has been observed in
healthy elderly subjects (range: 9.0-26.9 hours, n=16) compared to 11.0 hours (range: 6.3-15.8 hours, n=16)
in healthy adult subjects. Alprazolam and its metabolites are excreted primarily in the urine.
The pharmacokinetics of alprazolam and two of its major active metabolites (4-hydroxyalprazolam and
α-hydroxyalprazolam) are linear, and concentrations are proportional up to the recommended maximum daily
dose of 10 mg given once daily.
Peak concentrations in the plasma occur in one to two hours
following administration. Plasma levels are proportionate to the dose given; over the dose range of 0.5 to 3.0
mg, peak levels of 8.0 to 37ng/ml were observed.
PRINCIPLE
The ALP 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. Alprazolam, 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
alprazolam-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 Alprazolam level exceeds the cut-off level, because it will saturate all the
binding sites of anti- Alprazolam 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- Alprazolam antibody
coupled particles and alprazolam -protein conjugate. A goat antibody is employed in the control line system.
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 µL) 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.
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.
