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 detects variants Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Delta (B.1.617.2), Kappa (B.1.617), Eta (B.1.525), Iota (B.1.526) and Lambda (C.37).
- 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.
Advantages
- FDA Emergency Use Authorized and CE Marked
- 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)
- 3-target system minimizes impact of new SARS-CoV-2 variants
- Multiplex format allows for single-well detection of 3 different targets
- Endogeneous control informs effectiveness of procedures/overall specimen quality
- Validated on several popular PCR instruments
- Compatible with automated RNA extraction
Specifications
- Gene Targets: E, N, ORF1b
- Kit: 48 Reactions (yields 45 unknown sample results)
- Contents: Primer Probe Mix and Kit Controls
- Specimen: Nasopharyngeal or nasal swabs
Performance
- Sensitivity: 100% PPA
- Specificity: 96.7% NPA
Limit of Detection
- 7500 Fast Dx Real-Time PCR Instrument: 12.5 GE/reaction; 1100 GE/ml specimen
- CFX96 Touch Real-Time PCR Detection System: 10 GE/reaction; 860 GE/ml specimen
Catalog No. | Format | Quantity/Kit | Time to Result | Sample Type | Storage | Shelf Life |
---|---|---|---|---|---|---|
COV2-E (EUA) COV2-C (IO Health Canada) | rRT-PCR | 48 Reactions | ~4 hours | human nasopharyngeal, anterior nasal and mid-turbinate nasal swab | -20℃ or below | 12 months |