CHICAGO – The FDA Thursday greenlit the Alltest Fentanyl Urine Test Cassette, marking it the debut over-the-counter tool for initial detection of fentanyl in urine.
The test uses three drops of urine on a cassette gives results in five minutes. Jeff Shuren, M.D., J.D., Director at FDA’s Center for Devices and Radiological Health, emphasized the profound opioid crisis, stating, “This test is an example of the FDA’s continued commitment to authorize tools that can reduce deaths associated with overdoses.”
The test was approved just 16 days after being submitted to the agency. The test, which offers only preliminary insights, needs backup via a more specific chemical method for validation. Potential interferences from contamination or certain foods might skew results.