Status COVID-19/Flu A&B

A Rapid Immunoassay for the Simultaneous Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenza Type A and Type B Antigen from anterior nasal and nasopharyngeal swab specimens

• COVID-19
  - Anterior nasal swab specimen − Sensitivity 93.8 %, Specificity 100%
  - Nasopharyngeal − Sensitivity 93.1 %, Specificity 100%
• Flu A - Sensitivity 91.4%, Specificity 95.7%
• Flu B - Sensitivity 87.6%, Specificity 95.9%
• FDA Emergency Use Authorization (EUA)
• Visually read in 15 minutes
• Flocked nasopharyngeal swab for superior specimen collection and patient comfort

CorDx’s Multiplex Rapid Test empowers healthcare providers with world-class diagnostics that deliver rapid, comprehensive, and precise results. 

The CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2 and influenza A and B antigens. The test provides an efficient and accurate diagnostic solution in 10 mins, giving healthcare providers and communities a rapid and reliable way to prioritize their health. 

WELLlife™ COVID-19 / Influenza A&B Tests* utilize advanced immunoassay technology to quickly and accurately differentiate between SARS-CoV-2, influenza A, and influenza B with a single nasal swab. Recommended for rapid diagnostics, these tests are essential tools for timely management of viral infections, supporting swift treatment decisions during the flu season and amidst public health concerns.

• Cost-effective: Differentiate between SARS-COV-2, influenza A, and influenza B antigens with a single test using an anterior nasal swab specimen.
• Rapid Results: available in 10 minutes allows for testing and treatment decision-making during the same office visit.
• Quality Assurance: The outstanding clinical performance, including built-in kit controls for external quality testing, enables physicians to make quicker and more confident decisions.
• Extended Detection Window: Offers a broader detection window for differentiation of SARS-COV-2, influenza A, and influenza B antigens within five days of symptom onset.
• Wide Storage Temperature: 36°F-86°F (2°C-30°C) allows for easier product storage.

*For use under Emergency Use Authorization (EUA) only

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 protein antigen from SARS-CoV-2, influenza A and influenza B directly from anterior nasal or nasopharyngeal swab specimens collected from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five (5) days of onset of symptoms.

HIGHLY CORRELATED TO PCR:

• COVID-19: Sensitivity (Anterior nasal swab) 93.8%; Specificity 100%
• COVID-19: Sensitivity (Nasopharyngeal) 93.1%; Specificity 100%
• Flu A: Sensitivity 92.2%; Specificity 94.2%
• Flu B: Sensitivity 90.0%; Specificity 94.3%