Sample: | Urine | Type: | Cassette |
---|---|---|---|
Certificate: | ISO, CE | Origin: | China |
Shelf Life: | 24 Months | Usage: | Professional Use |
High Light: | Fentanyl Doa Test Kit,Urine Sample Doa Test Kit,FYL Rapid Test Cassette |
Fentanyl (FYL) Rapid Test
Fentanyl (FYL) Rapid Test is a rapid, screening test for the qualitative detection of Fentanyl (FYL) and metabolites in human urine at specified cut off levels.
For professional use only.
For in vitro diagnostic use only.
【INTENDED USE】
Fentanyl (FYL) Rapid Test is an immuno-chromatographic assay for the qualitative determination of the presence of Fentanyl (FYL) listed in the table below.
Drug(Identifier) | Calibrator | Cut-off level |
Fentanyl (FYL) | Ethyl -glucuronide | 500 ng/mL |
This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to Fentanyl (FYL) of abuse test result, particularly when preliminary positive results are indicated.
【SUMMARY】
Fentanyl is a potent, synthetic narcotic analgesic with a rapid onset and short duration of action. It is a strong agonist at the μ-opioid receptors. Historically it has been used to treat breakthrough pain and is commonly used in pre-procedures as a pain reliever as well as an anesthetic in combination with a benzodiazepine. It is approximately 80 to 100 times more potent than morphine and roughly 15 to 20 times more potent than heroin.
【PRINCIPLE】
Fentanyl (FYL) Rapid Test is a competitive immunoassay that is used to screen for the presence of Fentanyl (FYL) and metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites.
When the test is activated, the urine is absorbed into test by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test . This produces a colored Test line in the Test Region (T) of the test, which, regardless of its intensity, indicates a negative test result.
When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.
To serve as a procedure control, a colored line will appear at the Control Region (C) of test, if the test has been performed properly.
【WARNINGS AND PRECAUTIONS】
【CONTENTS】
【STORAGE AND STABILITY】
【OPERATION】
Test must be in room temperature (15ºC to 30ºC)
1. Donor collects urine specimen in a urine cup.
2. Open the sealed pouch by tearing along the notch. Remove the test from the pouch and place it on a level surface.
3. Hold the sample dropper vertically, and add exactly three drops of the urine specimen into the sample well.
4. The result should be read at 5 minutes. Do not interpret the result after 10 minutes. See the illustration below.
【INTERPRETATION OF RESULTS】
Preliminary positive (+)
Only one colored band appears, in the control region (C). No colored band appears in the test region (T).
Negative (-)
Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
Invalid
Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.