Fentanyl (FYL) Rapid Test,rapid immunochromatographic assay, detection of Norfentany
A rapid test for the qualitative detection of FYL in human urine. For medical and other professional in vitro diagnostic use only.
INTENDED USE
| Principle |
Chromatographic Immunoassay |
| Format |
Dipstick, Cassette, Panel, Device, Cup |
| Specimen |
Urine,Oral Fluid,Powder,WB/S/P |
| Certificate |
CE |
| Reading Time |
5 minutes |
| Pack |
25T/40T/50T |
| Storage Temperature |
2-30°C |
| Shelf Life |
2 Years |
| Sensitivity |
98.80% |
| Specificity |
99.40% |
| Accuracy |
99.20% |
| Cut-Off |
10 ng/mL,15 ng/mL ,20 ng/mL*,50 ng/ml* ,100 ng/mL ,200 ng/mL
|
The FYL (Fentanyl) Rapid Test Cassette (Urine) is a rapid immunochromatographic assay for the qualitative detection of Norfentanyl, a metabolite of Fentanyl. It is a potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Norfentanyl is also used as adjunct to general anaesthetics, and as an anaesthetic for induction and maintenance.
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
Fentanyl, belongs to powerful narcotics analgesics, and is a μ special opiates receptor stimulant. Fentanyl is one of the varieties that been listed in management of United Nations “Single Convention of narcotic drug in 1961”. Among the opiates agents that under international control, fentanyl is one of the most commonly used to cure moderate to severe pain1 . After continuous injection of fentanyl, the sufferer will have the performance of protracted opioid abstinence syndrome, such as ataxia and irritability etc2,3, which presents the addiction after taking fentanyl in a long time. Compared with drug addicts of amphetamine, drug addicts who take fentanyl mainly have got the possibility of higher infection rate of HIV, more dangerous injection behavior and more lifelong medication overdose 4. The FYL 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 Norfentanyl in urine. The FYL Rapid Test Cassette (Urine) yields a positive result when Norfentanyl in urine exceeds 20 ng/mL.
PRINCIPLE
The FYL 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. Fentanyl, if present in the urine specimen below 20 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 FYL 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 FYL level exceeds 20 ng/mL because it will saturate all the binding sites of anti-FYL 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-FYL antibody-coupled particles and FYL-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.
SPECIMEN COLLECTION AND PREPARATION
Urine Assay
The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may
be used. Urine specimens exhibiting visible particles should be centrifuged, filtered, or allowed to settle to
obtain clear specimen for testing.
Specimen Storage
Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For long-term storage, specimens
may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed before testing.
DIRECTIONS FOR USE
Allow 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 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.
The result should be read at 5 minutes. It is important that the background is clear before the result is read. 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 Norfentanyl concentration is below the detectable level (20 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 Norfentanyl concentration exceeds the detectable level (20 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
Order Information
| Cat. No. |
Product |
Specimen |
Pack |
| DFY-102 |
Fentanyl (FYL) Rapid Test Cassette |
Urine |
40 T |
| DFY-114 |
Fentanyl (FYL) Rapid Test Panel |
Urine |
40 T |
| DFY-101 |
Fentanyl (FYL) Rapid Test Dipstick |
Urine |
50 T |
| DFY-802 |
Fentanyl (FYL) Rapid Test Cassette |
Oral Fluid |
25 T |
| DFY-803 |
Fentanyl (FYL) Rapid Test Device |
Oral Fluid |
25 T |
| DFY-402 |
Fentanyl (FYL) Rapid Test Cassette |
WB/S/P |
40 T |
| DFY-X14 |
Fentanyl (FYL) Rapid Test Panel |
Powder |
25 T |
