FDA Grants Emergency Use Authorization for BD Coronavirus Test Kit

NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization (EUA) for Becton Dickinson's PCR-based SARS-CoV-2 detection kit.

The kit is designed for the qualitative detection of nucleic acid from SARS-CoV-2 nasal, nasopharyngeal, and oropharyngeal swab samples. Nucleic acid is extracted using the company's BD MAX ExK TNA-3 kit, and the test runs on the BD Max system.

Use of the test is limited to CLIA-certified labs, the FDA said.

Last week, Franklin Lakes, New Jersey-based Becton Dickinson and BioGX received EUA from the FDA for a rapid hospital SARS-CoV-2 test that runs on the BD Max system.