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