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.
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), B.1.427 & B.1.429 (California), and B.1.617/ B.1.617.1, B.1.617.2 & B.1.617.3 (India), as no mutations overlap the primer/probe sets.
- 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 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.
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