The Metrix® COVID/Flu Test is a reverse transcription and loop-mediated isothermal amplification (RT-LAMP) test intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B nucleic acid. This test is authorized for non-prescription home use with anterior nasal (AN) swab specimens from individuals aged 14 years or older (self-collected) or individuals aged 2 years or older (collected by an adult) with signs and symptoms of respiratory infection consistent with COVID-19. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.

The Metrix COVID/Flu Test is intended for use in the differential detection of SARS-CoV-2, influenza A, and influenza B nucleic acid in clinical specimens and is not intended to detect Influenza C. SARS-CoV-2, influenza A, and influenza B nucleic acid is generally detectable in anterior nasal swab specimens during the acute phase of infection.

Positive results indicate the presence of viral nucleic acid, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent detected may not be the definitive cause of disease. Individuals who test positive with the Metrix COVID/Flu Test should self-isolate and seek follow up care with their physician or healthcare provider as additional testing may be necessary.

Negative results do not rule out SARS-CoV-2, influenza A, and/or influenza B infection and should not be used as the sole basis for treatment or other management decisions, including infection control decisions. Negative results should be considered in the context of current prevalence of infection, an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with respiratory infection. Individuals who test negative and continue to experience symptoms of fever, cough and/or shortness of breath may still have a respiratory infection and should seek follow up care with their healthcare provider.

The Metrix COVID/Flu Test is only for use under the Food and Drug Administration’s Emergency Authorization.

This 25 pack contains: instructions and 25 collectors, 25 caps, 25 sensors, and 25 nasal swabs.

This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA;

This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens; and,

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.