FDA releases information associated with two In Vitro diagnostic EUAs for the testing of SARS-CoV-2, including an Individual EUAs for Diagnostic Breath Tests for SARS-CoV-2 and an Individual EUAs for Genotyping Tests for SARS-CoV-2, according to a news release.
Individual EUAs for Diagnostic Breath Tests for SARS-CoV-2:
SARS-CoV-2 diagnostic tests analyze breath samples and have been authorized individually. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and the settings authorized to use the EUA product.
Individual EUAs for Genotyping Tests for SARS-CoV-2:
SARS-CoV-2 genotyping tests have been authorized for the identification and differentiation of SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages. These EUAs have been issued for each individual test with certain conditions of authorization, including those required of the manufacturer, and the settings authorized to use the EUA product.
Authorized settings include the following:
- Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
- Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
- Patient care settings operating under a CLIA Certificate of Waiver.
