ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test

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. 

• Efficient: 1 sample – 3 results to aid in a differential diagnosis at the point of care

• Rapid: actionable results at 15 minutes to help improve patient management decisions during the patient visit

• Instrument-free: user-friendly test procedure for non-lab settings

• Accurate:

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

              COVID-19 (Nasopharyngeal): Sensitivity 93.1%; Specificity 100%

              Flu A: Sensitivity 92.2%; Specificity 92.4%

              Flu B: Sensitivity 90.0%; Specificity 94.3%

Influenza (flu) is a highly contagious acute viral infection of the respiratory tract. It is a communicable disease easily transmitted from person to person through aerosol droplets excreted when sneezing and coughing. There are two main types of influenza – type A and type B.2

Early differential diagnosis of influenza type A or type B can allow for proper treatment. Early diagnosis and treatment are of particular value in a clinical setting where an accurate diagnosis can assist the healthcare professional with the management of influenza patients who are at risk for complications.3

COVID-19 is an infectious disease caused by the SARS-CoV-2 virus. Similar to influenza, the virus can spread from an infected person’s mouth or nose ranging from larger respiratory droplets to smaller aerosols.4 COVID-19 symptoms can range from mild to severe.

As the early symptoms of COVID-19 are like those of seasonal influenza type A or B, a rapid, point- of-care test can help support the differential diagnosis of COVID-19, influenza A and B. 

ViraDx [package insert] PM-169.2. Carlsbad, CA: Lumos Diagnostics; 2023.

Centers for Disease Control and Prevention (CDC) - Frequently Asked Influenza (Flu) Questions: 2021-2022 Season - https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm.

World Health Organization (WHO) recommendations on the use of rapid testing for influenza diagnosis, July 2005.

Centers for Disease Control and Prevention (CDC) - Similarities and Differences between Flu and COVID-19. https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm