Germaine™ Laboratories Healgen™ External Controls: COVID-19/Flu A and B Ag Combo Rapid Test Cassette

Catalog No.	For Use With (Equipment)
22-026-007	Laboratories

Catalog No. 22-026-007 Supplier Germaine™ Laboratories Supplier No. GCFCPN2

Description

Controls for lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigens.

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

• 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