FDA Approves First Qualitative Rapid Urine Test For Fentanyl

Finally, we now have a qualitative rapid urine test to identify the presence of Fentanyl, an adulterant in drugs that have killed almost 100,000 Americans in the past 12 months.  Here is the announcement from the FDA:

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.

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