Carfentanyl (CFYL) Rapid Test Cassette , qualitative detection of Carfentanyl in human urine
A rapid test for the qualitative detection of Carfentanyl in human urine.
For medical and other professional in vitro diagnostic use only.
| Principle |
Chromatographic Immunoassay |
| Format |
Dipstick, Cassette, Panel, Device, Cup |
| Specimen |
Urine, Oral Fluid, Powder |
| Certificate |
CE |
| Reading Time |
5 minutes |
| Pack |
25T/40T/50T |
| Storage Temperature |
2-30°C |
| Shelf Life |
2 Years |
| Sensitivity |
94.70% |
| Specificity |
98.60% |
| Accuracy |
97.30% |
| Cut-Off |
500 ng/mL*, 250 ng/mL, 50 ng/mL* |
INTENDED USE
The Carfentanyl Rapid Test Cassette (Urine) is a rapid immunochromatographic assay for the qualitative detection of carfentanyl. This test will detect other compounds, please refer to Analytical Specificity table in this package insert.
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 whenpreliminary positive results are used.
SUMMARY
Carfentanyl is an analog of the synthetic opioid analgesic fentanyl. It is 10,000 times more potent than morphine, making it among the most potent commercially used opioids. Carfentanil was first synthesized in 1974.
It is marketed under the trade name Wildnil as a general anaesthetic agent for large animals. 2 Side effects of carfentanil are similar to those of fentanyl, which include itching, nausea and respiratory depression, which can be life-threatening.
Carfentanil is classified as Schedule II under the Controlled Substances Act in the United States with a DEA ACSCN of 9743 The Carfentanyl 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 Carfentanyl in urine. The Carfentanyl Rapid Test Cassette (Urine) yields a positive result when Carfentanyl in urine exceeds 500 ng/ml.
PRINCIPLE
The Carfentanyl 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. Carfentanyl, if present in the urine specimen below 500 ng/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 Carfentanyl 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 Carfentanyl level exceeds 500 ng/ml because it will saturate all the binding sites of anti- Carfentanyl 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-Carfentanyl antibody-coupled particles and Carfentanyl-protein conjugate.
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.
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 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). A negative result indicates that the Carfentanyl concentration is below the detectable level (500 ng/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 Carfentanyl concentration exceeds the detectable level (500 ng/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.
