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 Variant B1.1.7
The primers and probes included in InBios’s Smart Detect™ SARS-CoV-2 rRT-PCR kit have been analyzed against the mutant variant B1.1.7, which emerged from the United Kingdom. The primer/probe sets included in this product were aligned relative to the sequence of the new variant. No mutations in the B1.1.7 variant were found to overlap with the primer/probe sets. Thus, the Smart Detect™ SARS-CoV-2 rRT-PCR kit is anticipated to detect mutant variant B1.1.7 without issue.
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