Smart Detect™ SARS-CoV-2 rRT-PCR Kit
FDA Emergency Use Authorized – Amended June 3, 2020
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.
Please click here for Frequently Asked Questions.
Click Downloads Below For:
- Letter of Authorization
- Amendment Letter Dated June 3, 2020
- Package Insert (English)
- Patient Fact Sheet
- Health Care Provider Fact Sheet
- SARS-CoV-2 rRT-PCR Kit Brochure