The FDA cleared for commercial distribution a diagnostic panel that tests for multiple respiratory viral and bacterial infections on Feb. 3.
The BioFire Spotfire Respiratory Panel is the first COVID-19 test cleared with a CLIA waiver, according to an AHA news release shared with Becker's. Any lab with at least a CLIA certificate of waiver can use it.
The panel diagnoses infections in respiratory specimens from patients with suspected respiratory infections including COVID-19, according to the news release.
It consists of a closed system disposable pouch with all necessary reagents for sample preparation, reverse transcription, PCR and detection from a single swab specimen