The Sefria fentanyl urine enzyme immunoassay from Immunalysis Corp, Pomona, Calif, has received FDA premarket notification (510(k)) clearance for the qualitative detection of fentanyl in urine.

According to Immunalysis, the test is the first 510(k)-cleared fentanyl enzyme immunoassay, and is the first analyte utilizing the company’s proprietary Sefria ?-galactosidase enzyme-based immunoassay technology.

Previously, fentanyl immunoassay tests were available only for forensic testing. With the new clearance, fentanyl drug screening is now available for use in certified reference laboratories, hospitals, physician offices, and other healthcare settings that perform moderate-complexity testing under the terms of the Clinical Laboratory Improvement Amendments of 1988.

“The availability of an FDA-cleared fentanyl immunoassay enables more reference and hospital laboratories to conduct precise qualitative screening, which is a key strategy in stemming the alarming increase in misuse and abuse of fentanyl,” says Kathy Miller, vice president of sales and marketing at Immunalysis Corp. “The Sefria fentanyl urine drug screening test rounds out our offering of technologically advanced assays for detecting prescription and illegal drugs of abuse by providing clinicians and toxicologists with a relevant menu of FDA-cleared opiate and opioid tests.”

According to the Centers for Disease Control and Prevention, death rates from synthetic opioids such as fentanyl increased by 72.2% from 2014 to 2015, due in part to their low cost and high potency, which can be up to 50 times greater than heroin and 100 times greater than morphine.1 Drug overdoses associated with fentanyl are often linked to unintentional ingestion when it is combined with street-sold heroin or cocaine, significantly amplifying its potency.

The Sefria fentanyl urine enzyme immunoassay detects the presence of fentanyl in urine with a cutoff of 1 ng/mL. In clinical performance studies, testing with the immunoassay compared favorably to liquid chromatography-mass spectrometry analysis in both sensitivity and specificity.

For more information, visit Immunalysis.

REFERENCE

  1. Synthetic opioid data [online]. Atlanta: Centers for Disease Control and Prevention, 2016. Available at: cdc.gov/drugoverdose/data/fentanyl.html. Accessed August 24, 2017.