A rapid, one step test for the qualitative detection of Fentanyl in human urine For in vitro diagnostic use only, It is intended for laboratory use only.
The One Step Fentanyl Test Cassette is a lateral flow chromatographicimmunoassay for the detection of Fentanyl in human urine.
This assay provides only a preliminary analytical test result. A morespecific alternate chemical method must be used in order to obtain aconfirmed analytical result. Gas chromatographylmass spectrometry(GCIMS) is the preferred confirmatory method. Clinical considerationand professional judgment should be applied to any drug of abuse testresult,particularly when preliminary positive results are used. lt isintended for laboratory use only.
Directions For Use
Allow the test Cassette,urine specimen，and/or controls to reach roomtemperature (15-30℃) prior to testing.
1) Remove the test cassette from its foil wrapper by tearing along the slice(bring the container to the room temperature before opening to avoidcondensation of moisture in container). Label the cassette with patient orcontrol identifications.
2) Using the specimen dropper, withdraw the urine sample from the specimencup and slowly dispense 3 drops (approximately 120uL) into the circularsample well, being careful not to overfill the absorbent pad.
3) Read results at 5 minutes.
Do NOT INTERPRET RESULT AFTER 10 MINUTES.
1. The One Step Fentanyl Test Cassette provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.
2. It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.
3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.
4. A positive result indicates presence of the drug or its metabolites but does not indicate level of intoxication, administration route or concentration in urine.
5. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of the test.
6. Test does not distinguish between drugs of abuse and certain medications.