FDA grants waiver for rapid RSV test
The FDA has granted Alere a Clinical Laboratory Improvement Amendments waiver for its rapid diagnostic test for respiratory syncytial virus, according to a press release.
The Alere i RSV test is the first point-of-care molecular test that can detect RSV in children and adults within 13 minutes or less, according to the manufacturer. The test was initially cleared for marketing in August. With the recent Clinical Laboratory Improvement Amendments (CLIA) waiver, it will now be widely available in physician offices, emergency rooms and walk-in clinics throughout the U.S.
The test is performed on the Alere i molecular platform and uses Alere’s Molecular In Minutes isothermal nucleic acid amplification technology to detect RSV in nasopharyngeal swab samples. In clinical performance studies, Alere i RSV produced results with 98.6% sensitivity and 98% specificity compared with PCR.
“Our innovative Alere i platform now offers the key trio of respiratory assays for rapid molecular detection of RSV, influenza A and B and strep A in a broad range of health care settings,” Avi Pelossof, global president of infectious disease at Alere, said in the release. “Health care providers can now deploy the power of rapid molecular testing to quickly and accurately differentiate these potentially serious infections and link patients to the appropriate treatment.”
Disclosure: Pelossof is an employee of Alere.