ViraDx® Influenza A, Flu B and Covid Antigen Rapid Test, CLIA Waived, pack/25

The ViraDx™ SARS-COV-2/FLU A+B RAPID ANTIGEN TEST is CLIA-Waived. For professional use only. Ideal for businesses testing employees. Not for home or self-testing. Business address will be required prior to shipment.

ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from anterior nasal or nasopharyngeal swab specimens obtained from patients who are suspected of COVID-19 by their healthcare provider, within the first five days of onset of symptoms.

• Detects and differentiates Sars COVID-19, Flu A and Flu B with one sample
• Results at 15 minutes
• User-friendly test procedure

Specifications

• Sample Type: Anterior nasal or nasopharyngeal swab
• Detection Targets: Nucleocapsid protein (N protein) of SARS-CoV-2, Flu A and Flu B antigen
• Suitable for: Patients suspected of respiratory viral infection consistent with COVID-19 within first 5 days of symptoms
• Setting: Testing sites that meet the requirements to perform point-of-ca retesting
• Method: Lateral flow
• Interpretation: Visual read at 15 minutes
• Storage: 2 to 30° C (35 to 86°F)

Clinical Performance:

COVID-19 (Anterior nasal swab): Sensitivity 93.8%; Specificity 100%
COVID-19 (Nasopharyngeal): Sensitivity 93.1%; Specificity 100%

Flu A: Sensitivity 92.2%; Specificity 94.2%
Flu B: Sensitivity 90.0%; Specificity 94.3%

MATERIALS PROVIDED

• 25 Single Use Test Devices
• 1 positive control and 1 negative control
• Package Insert
• 1 Quick Reference Instructions

ViraDx Emergency Use Authorization Number (EUA): EUA220131

FOR PROFESSIONAL USE ONLY