FDA approves 1st COVID-19 test cleared with CLIA waiver

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


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