DiaCarta Gets Emergency Use Authorization for COVID-19 Test Kit

The FDA has granted DiaCarta an Emergency Use Authorization for its QuantiVirus SARS-CoV-2 multiplex test kit.

The QuantiVirus test detects nucleic acid from the SARS-CoV-2 virus in upper respiratory specimens. The agency said negative results from the test “ should not be used as the sole basis for patient management decisions.”

All printed materials with the kit must make clear that the test is only for emergency use by authorized laboratories and that it has not been cleared or approved by the agency.