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.
FAQs:
Please click here for Frequently Asked Questions.
Click Downloads Below For:
- FAQs
- 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
Advantages
- FDA Emergency Use Authorized and CE Marked
- 3 target-system minimizes potential for reduced detection of new SARS-CoV-2 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
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 | rRT-PCR | 48 Reactions | ~4 hours | human nasopharyngeal, anterior nasal and mid-turbinate nasal swab | -20℃ or below | 12 months |