Is the coronavirus test approved by the FDA and recommended by the CDC?
Our CLIA-certified national lab provider offers The SARS-CoV-2 (COVID-19) test that uses the FDA Emergency Use Authorization (EUA) approved CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel, that’s intended for the detection of COVID-19 in individuals who meet CDC or public health criteria for COVID-19 testing.
It's important to note that:
- This test has not been FDA cleared or approved
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the detection of nucleic acid from 2019-nCoV, not for any other viruses or pathogens, and;
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of SARS-CoV-2 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.