Smart Detect™ SARS-CoV-2 rRT-PCR Kit FDA Emergency Use Authorized, Authorized under Interim Order (IO) in Canada, and CE Marked
Smart DetectTM SARS-CoV-2 rRT-PCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) in human nasopharyngeal swab, anterior nasal swab and mid-turbinate nasal swab specimens from individuals suspected of COVID-19 by their healthcare provider. Clinical laboratories that are certified under Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, to perform high complexity tests in the U.S. can immediately begin using this kit, which offers results in about 4 hours.
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 SARS-CoV-2, 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 COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.