FDA Clears First OTC Fentanyl Urine Test

The US Food and Drug Administration (FDA) has cleared the first over-the-counter test for the preliminary detection of fentanyl in urine.

With the Alltest Fentanyl Urine Test Cassette (Hangzhou AllTest Biotech Co, Ltd), three drops of fresh urine are placed onto a cassette containing a fentanyl test strip. After 5 minutes, the test result appears as colored lines.

“Opioid abuse, misuse and addiction is one of the most profound public health crises facing the US today. It is also a very personal issue for many people, impacting individual lives and families,” Jeff Shuren, MD, JD, director, the FDA Center for Devices and Radiological Health, said in a statement.

Shuren said this test is an example of the FDA’s “continued commitment to authorize tools that can reduce deaths associated with overdoses. The agency expedited review of this test, making a decision on the submission in only 16 days from the date it was received.”

The FDA cautions that the urine test provides only a preliminary result and that a more specific, alternative chemical method (confirmation testing) must be used to confirm the result.

The Alltest Fentanyl Urine Test Cassette includes a preaddressed mailing box for shipping samples to the manufacturer’s laboratory for confirmation testing.

The FDA also notes that the test may provide an incorrect result if the urine sample is contaminated, for example, by adding bleach. The test does not distinguish between drugs of abuse and certain medications. Consuming certain foods or food supplements can lead to a false positive test result.

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