The FDA has issued emergency use authorizations for two tests.
Summary of Key Points:
CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel
The FDA has reauthorized the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. In summary, testing is now intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory specimens collected from individuals who meet COVID-19 clinical and/or epidemiological criteria (for example, clinical signs and symptoms associated with COVID-19, contact with a probable or confirmed COVID-19 case, history of travel to a geographic locations where COVID-19 cases were detected, or other epidemiologic links for which COVID-19 testing may be indicated as part of a public health investigation). In addition, testing in the United States is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests.
Panther Fusion SARS-CoV-2
On March 16, 2020, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use the Hologic, Inc. (Hologic) Panther Fusion SARS-CoV-2 for the qualitative detection of nucleic acid from SARS-CoV-2 isolated and purified from nasopharyngeal (NP) and oropharyngeal (OP) swab specimens obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3). The Panther Fusion SARS-CoV-2 is for use only under EUA in United States (U.S.) laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
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