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Description
- Screen asymptomatic individuals to help prevent the silent spread of SARS-CoV-2
- Provide answers patients need in 20 min. enabling quick actions to manage patient care
- Offers broad strain coverage of SARS-CoV-2 variants
Specifications
Specifications
| Certifications/Compliance | EUA |
| Content And Storage | 2°C to 8°C |
| Control Sets | SARS-CoV-2 Control Kit used to verify each new lot of SARS-CoV-2 assay |
| CPT Code | 87635 |
| CE Marker | Yes |
| Clia Complexity | Waived |
| Detectable Analytes | ORF 1a/b and N gene SARS-CoV-2 |
| Format | Assay Tube |
| Sample Type | Nasopharyngeal swab, Mid turbinate swab, Nasal swab |
| Sensitivity | SARS-CoV-2: Symptomatic individuals: 96.1% Positive Agreement, 96.8% Negative Agreement; Asymptomatic individuals 100% Positive Agreement, 98.9% Negative Agreement* *compared to an FDA-cleared EUA, Cobas™ SARS-CoV-2 Test on Cobas™ 6800/8800 systems |
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