Respiratory Test Kit Metrix® COVID / Flu Test 25 Tests

Features

• The Metrix COVID/Flu Test has been authorized for emergency use by FDA under an EUA: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
• 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
• 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
• 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
• Requires the Metrix Reader (Gen 2) - sold separately

More Information

• Metrix COVID and FLU FDA EUA Letter
• Metrix COVID and FLU IFU
• Metrix COVID and FLU Home Test IFU
• Metrix COVID and FLU Healthcare Providers Fact Sheet
• Metrix Covid and Flu Sales Sheet