Smart Detect™ SARS-CoV-2 rRT-PCR Kit
FDA Emergency Use Authorized
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.
FAQs
Please click here for Frequently Asked Questions.
More Information (click Downloads button below)
- Letter of Authorization
- Package Insert (English/Spanish)
- Patient Fact Sheet
- Health Care Provider Fact Sheets
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
Advantages
- FDA Emergency Use Authorized
- 3 target-system minimizes potential for reduced detection of new SARS-CoV-3 variants
- Multiplex format allows for single-well detection of 3 different targets
- Compatible with multiple PCR instruments after proper validation
- Compatible with multiple RNA extraction kits after proper validation
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 | rRT-PCR | 48 Reactions | ~4 hours | human nasopharyngeal, anterior nasal and mid-turbinate nasal swab | -20℃ or below | 12 months |