MARCH 7, 2017

FDA Grants CLIA Waiver for the Alere i RSV Rapid Molecular Test

By IDSE News Staff

The FDA granted a CLIA (Clinical Laboratory Improvement Amendments) waiver to the Alere i RSV test for the detection of respiratory syncytial virus infection in children and adults. The waiver allows the test to be used in physicians offices, hospital emergency rooms and other point-of-care locations for faster diagnosis.

“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