ALLTEST® Biotech Fentanyl FEN FYL (Synthetic Heroin) 1ng/mL Single Panel Rapid Cassette Drug Test, CLIA Waived, 25/Box

The First and Only CLIA Waived test for Fentanyl

The ALLTEST BIOTECH CO, LTD. Fentanyl rapid urine cassette test is an immuno-assay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This in vitro diagnostic device is for prescription use only. This test is FDA 510(k) Cleared, OTC (Over the Counter Home Use), and CLIA Waived.

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FEATURES

• FDA 510(k) Cleared - FDA #K231698
• CLIA Waived - FDA #K233417
• OTC for Home Use - FDA #K233417
• First ever FDA Cleared Alltest Fentanyl Rapid Test
• Single Drug Test
• Results within 5 Minutes
• Great for Home and Office
• Easy to Read Results
• 12-18 month expiration date on all drug test kits

APPLICATIONS

The FYL (Fentanyl) Rapid Test (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.

DESCRIPTION

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 pain. 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.

HOW TO USE?

1. Allow the test, urine specimen, and/or controls to reach room temperature (15-30°C) prior to testing.
2. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.
3. Place the test cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 120μL) 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.
4. Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 10minutes.

REFERENCE DOCUMENTS

 Fentanyl CassettePackage Insert - CLIA Moderately Complex

 Fentanyl Cassette Package Insert - CLIA Waived

 Fentanyl Cassette User Instructions - OTC for Home Use

INTERPRETATION OF RESULTS

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.
 
*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.
 
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.