Smart Detect™ SARS-CoV-2 rRT-PCR Kit
FDA Emergency Use Authorized (Amended Aug. 24, 2020) 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.
Update! Mutant Variants
InBios’s Smart Detect™ SARS-CoV-2 rRT-PCR kit is predicted to detect variants B.1.1.7 (UK), B.1.351 (South Africa), P.1 (Brazil), B.1.526 (New York), and B.1.427 & B.1.429 (California), as no mutations overlap the primer/probe sets.
Please click here for Frequently Asked Questions.
Click Downloads Below For:
- Package Insert (English & Spanish)
- PCR SDS (US & EU)
- Master Mix SDS (US & EU)
- FDA Letter of Authorization
- Fact Sheet for Patients
- Fact Sheet for Health Care Providers
- Amendment Letters 1, 2 & 3