SCREEN DRUG TEST FENTANIL RAPID TEST QUALITATIVE DETECTION OF FYL IN HUMAN URINE SCREEN ITALIA

Description
A rapid test for the qualitative detection of FYL in human urine.
For medical and other professional in vitro diagnostic uses only.
The FYL ( Fentanyl ) Rapid Test Panel (Urine) is a rapid immunochromatographic test for the qualitative detection of Norfentanyl, a metabolite of Fentanyl. It is a potent narcotic analgesic, the abuse of which leads to habituation or dependence. It is primarily a mu-opioid agonist. Norfentanyl is also used as an adjunct to general anesthetics and as an induction and maintenance anesthetic.
This test provides only a preliminary analytical result. A more specific alternative chemical method should be used 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.
The FYL Rapid Test Panel (Urine) is an immunoassay based on the principle of competitive binding. Drugs present in the urine specimen compete with the drug conjugate for binding sites on the antibody.
During testing, the 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 the antibody-coated particles in the test device. The antibody-coated particles will then be captured by the immobilized FYL conjugate and a visible colored line will appear 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 binding sites of the 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 below the cut-off will generate a line in the test line region. As a procedural control, a colored line will always appear in the control line region, indicating that the correct volume of specimen has been added and membrane wicking has occurred.

How to use
Urine test
The urine sample should be collected in a clean, dry container. Urine collected at any time of the day may be used. Urine samples that have visible particles should be centrifuged, filtered, or allowed to settle to obtain a clear sample for testing.
Sample storage
Urine samples may be stored at 2-8°C for up to 48 hours prior to testing. For long-term storage, samples may be frozen and stored below -20°C. Frozen samples should be thawed and mixed prior to testing.
Allow the test, urine specimen and/or controls to reach room temperature (15-30°C) before testing. 1. Allow the pouch to reach room temperature before opening. Remove the test panel from the sealed pouch and use within one hour.
2. Remove the cap.
3. With the arrow pointing toward the urine specimen, immerse the test panel vertically into the urine specimen for at least 10-15 seconds. Immerse the strip at least to the level of the wavy lines, but not beyond the arrow on the test panel.
4. Replace the cap and place the test panel on a flat, non-absorbent surface.
5. Start the timer and wait for the colored lines to appear.
6. The result should be read after 5 minutes. Do not interpret the result after 10 minutes.

Interpretation of results
NEGATIVE:* Two colored 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 color tone in the test line (T) region may vary, but is considered negative whenever even a faint colored line is present.
POSITIVE: A 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 does not appear. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure.
Review the procedure and repeat the test with a new test. If the problem persists, discontinue use of the lot immediately and contact your local distributor.

Warnings
- For medical and other professional in vitro diagnostic use only. Do not use after the expiration date.
- The test must remain in the sealed pouch until use.
- All specimens should be considered potentially hazardous and treated as an infectious agent.
- The used test must be discarded according to local regulations.

Limitations
1. The FYL Rapid Test Panel (Urine) provides only a qualitative and 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 the presence of the drug or its metabolites, but does not indicate the level of intoxication, the route of administration, or the concentration in the urine.
5. A negative result does not necessarily indicate drug-free urine. Negative results may occur when drug is present but below the test cut-off level.
6. The test does not distinguish between drugs of abuse and some medications.

Conservation
Store as packaged at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch or on the label of the closed container. The test must remain in the sealed pouch or closed container until use. Do not freeze. Do not use beyond the expiration date.
Validity of intact packaging: 24 months.

Format
Test panels, package insert.

Code 988717017