Clonazepam Rapid Test Cassette (Urine), CLO Detection, 400ng/ml cut off,chromatographic immunoassay
A rapid test for the qualitative detection of Benzodiazepines 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 |
97.10% |
| Specificity |
99.30% |
| Accuracy |
98.40% |
| Cut-Off |
150 ng/mL, 400 ng/mL* |
INTENDED USE
The CLO Rapid Test Cassette (Urine) is a rapid chromatographic immunoassay for the detection of Clonazepam in urine at a cut-off concentration of 400ng/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
Clonazepam is a benzodiazepine drug having anxiolytic, anticonvulsant, muscle relaxant, amnestic, sedative, and hypnotic properties. Clonazepam has an intermediate onset of action, with a peak blood level occurring one to four hours after oral administration. Long-term effects of benzodiazepines include tolerance, benzodiazepine dependence, and benzodiazepine withdrawal syndrome, which occurs in one third of patients treated with clonazepam for longer than four weeks. Benzodiazepines such as clonazepam have a fast onset of action, high effectivity rate, and low toxicity in overdose; however, as with most medications, it may have drawbacks due to adverse or paradoxical effects.The detection period for the Benzodiazepines in the urine is 3-7 days.
The CLO Rapid Test Cassette (Urine) is a rapid urine-screening test that can be performed without the use of an instrument. The test utilizes the antibody to selectively detect elevated levels of Benzodiazepines in urine. The CLO Rapid Test Cassette (Urine) yields a positive result when the Benzodiazepines in urine exceeds the cut-off level.
PRINCIPLE
The CLO 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. Benzodiazepines, 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 Benzodiazepines-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 Benzodiazepines level exceeds the cut-off level, because it will saturate all the binding sites of anti-Benzodiazepines 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-Benzodiazepines antibody coupled particles and Benzodiazepines-protein conjugate. 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.
Allow the test, urine specimen, and/or controls to reach room temperature (15-30°C) 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 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 10 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* Two 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). This negative result indicates that the Benzodiazepine concentration is below the detectable cut-off level.
*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). This positive result indicates that the Benzodiazepine concentration exceeds the detectable cut-off level.
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 with a new test. If the problem persists, discontinue using the test kit 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.
