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.