Sefria Fentanyl Screening Test Gets FDA Clearance

Fentanyl immunoassay testing now available outside of forensic testing
Fentanyl immunoassay testing now available outside of forensic testing

Immunalysis announced that the Food and Drug Administration (FDA) has granted clearance for Sefria Fentanyl Urine Enzyme Immunoassay for the qualitative detection of fentanyl in urine, the first 510(k) cleared fentanyl enzyme immunoassay. 

Before Sefria, fentanyl immunoassay tests were only available for forensic testing. Now, fentanyl screening is available for Clinical Laboratory Improvement Amendments (CLIA) certified labs, hospitals, physician offices, and other healthcare settings. 

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The Centers for Disease Control and Prevention (CDC) reported that rates of death from synthetic opioids (eg, fentanyl) rose by 72.2% from 2014 to 2015, partially due to its low cost and high potency. Fentanyl can be up to 50 times stronger than heroin and 100 times stronger than morphine; it is administered intravenously, or as a transdermal patch, flavored lozenge, lollipop, buccal tablet, nasal spray, or inhalant. Although it has all the properties of morphine, it cannot be detected in screening tests for morphine or related opiates due to its different structure.

The Sefria (synthetic enzyme fragment immunoassay) test works by detecting fentanyl in urine with a cutoff of 1ng/mL. The technology is developed from artificial fragment of β-galactosidase, an E. coli enzyme. In clinical studies, use of Sefria was comparable with liquid chromotography-mass spectrometry (LC-MS) analysis in both sensitivity and specificity. It has demonstrated cross-reactivity with acetyl fentanyl, butyryl fentanyl, despropionyl fentanyl, and sufentanil.

For more information call (888) 664-8378 or visit Immunalysis.com.