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Description
- Cost-effective, high performing test designed for decentralized testing
- Visually read results in 15 min.
- No instrument required
- Simple test procedure using direct nasal swab
- Onboard extraction allows swab to be directly inserted into test card
- Room temperature storage
Includes:
- 40 cardboard, book-shaped hinged test cards with test strips
- 1 x 7.5 mL extraction reagent bottle with reagent
- 40 sterile nasal swabs
- 1 positive control swab
- Non-infectious recombinant SARS-CoV-2 nucleocapsid antigen
- 1 negative control swab
- 1 product insert
- 1 procedure card
Notes:
- Emergency Use Authorization (EUA) supports testing in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
Specifications
Specifications
| Certifications/Compliance | EUA |
| Content And Storage | 2°C to 30°C |
| CPT Code | 87811 |
| Clia Complexity | Waived |
| Detectable Analytes | SARS-CoV-2 Nucleocapsid Protein Antigen |
| Detection Method | Lateral flow immunoassay |
| Sample Type | Direct Nasal Swab |
| Sensitivity | 84.6% |
| Type | COVID-19 Test |
| Disposable | Single-use |
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