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Germaine™ Laboratories Healgen™ External Controls: COVID-19/Flu A and B Ag Combo Rapid Test Cassette
Description
Lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 by their healthcare provider within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Positive results do not rule out bacterial infection or co-infection with other viruses.
Detect Three Respiratory Viruses Simultaneously from a Single Sample: Faster diagnosis for improved patient care and cost-effectiveness
- Rapid Detection: Results available in 15 minutes
- Excellent Test Performance (comparator method RT-PCR)
- Simple and Effective: CLIA Waived testing at the point-of-care for use with minimally trained healthcare professionals
- External Quality Controls Available: Facilitates routine quality procedures
- Shelf Life that Spans Viral Seasonality: 16 months from date of manufacture at room temperature storage
Specifications
Specifications
| Detectable Analytes | Influenza A and Influenza B Nucleoprotein Antigens, SARS-CoV-2 Nucleocapsid Antigen |
| Format | Test Cassette |
| For Use With (Equipment) | Laboratories |
| Sample Type | Nasal Swab |
| Type | Nasal Swab Control |
| Disposable | Single-use |
| Level | 1, 2 |
| Sterility | Sterile |
| Form | Swab |
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