Germaine™ Laboratories SpeedySwab™ COVID-19/FLU AB Rapid Test

Description

Lateral flow immunochromatographic assay intended for in-vitro rapid, simultaneous qualitative detection and differentiation of influenza A and B nucleoprotein antigens and SARS CoV-2 nucleocapsid antigen.

• Lateral flow immunochromatographic assay intended for in-vitro rapid, simultaneous qualitative detection and differentiation of influenza A and B nucleoprotein antigens and SARS CoV-2 nucleocapsid antigen
• Sample directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five days of symptom onset when tested at least twice over three days with at least 48 hours between tests
• This test is FDA/EUA authorized for use at the Point of Care, i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Specifications

• CE Marker: No
• Clia Complexity: Waived (EUA)
• Detectable Analytes: Influenza A and B, COVID-19/2019-nCOV
• Detection Method: Simultaneous Qualitative Detection
• DoA Calibrators: No
• Format: Kit
• Sample Type: Single Nasal Swab Sample
• Sensitivity: COVID Clinical Sensitivity: 92.6%;, FLU-A Clinical Sensitivity: 82.9%, FLU-B Clinical Sensitivity: 90.0%, Refer to the Package Insert for additional performance claims
• Type: Rapid Test
• Disposable: Single-use
• For Use With (Application): Covid and Flu AB Rapid Test
• Form: Ready-to-Use (RTU)