CNB (Cannabinol) Rapid Test Cassette(Urine), monoclonal antibody,Specificity 97.6%
A rapid test for the qualitative detection of Cannabinol 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 | 95.80% |
| Specificity | 97.60% |
| Accuracy | 96.90% |
| Cut-Off | 500 ng/mL |
INTENDED USE
The CNB Rapid Test Cassette (Urine) is a rapid immunochromatographic assay for the qualitative detection of Cannabinol (CNB) at a cut-off concentration of 500 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
Cannabinol (CNB) is a non-psychoactive cannabinoid found only in trace amounts in Cannabis,1 and is mostly found in aged Cannabis.2 Pharmacologically relevant quantities are formed as a metabolite of tetrahydrocannabinol (THC).3CNB acts as a partial agonistat the CB1 receptors, but has a higher affinity to CB2 receptors; however, it has lower affinities relative to THC.4,5 Degraded or oxidized cannabis products, such as low-quality baled cannabis and traditionally produced hashish, are high in CNB, but modern production processes minimize the formation of CNB.
Unlike other cannabinoids, CNB does not stem from cannabigerol (CBG). There is no clinical evidence that THC breaks down naturally into CNB once the THC has become decarboxylated and forms delta-9 THC. CNB is formed by decarboxylation of cannabinolic acid.
The CNB 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 CNB in urine. The CNB Rapid Test Cassette (Urine) yields a positive result when CNB in urine exceeds 500ng/ml.
PRINCIPLE
The CNB 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. CNB, if present in the urine specimen below 500ng/ml, will not saturate the binding sites of antibody-coated particles in the test line region. The antibody-coated particles will then be captured by immobilized CNB 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 CNB level exceeds 500ng/ml because it will saturate all the binding sites of anti-CNB 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.
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 L) 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.
REAGENTS
The test cassette contains mouse monoclonal anti-CNB antibody-coupled particles and CNB-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.
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). A negative result indicates that the CNB concentration is below the detectable level (500ng/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 CNB concentration exceeds the detectable level (500ng/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.
EXPECTED VALUES
This negative result indicates that the Cannabinol (CNB) concentration is below the detectable level of 500ng/ml. Positive result means the concentration of CNB is above the level of 500ng/ml. The CNB Rapid Test Cassette has a sensitivity of 500ng/ml.
