Respiratory Test Kit WELLlife™ COVID-19 / Influenza A&B 25 Tests

Features

• The WELLlife™ COVID-19 / Influenza A&B Test Control Kit is For use under an Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
• The WELLlife™ COVID-19 / Influenza A&B Test Control Kit is intended for in vitro diagnostic use in quality control testing with the WELLlife™ COVID-19 / Influenza A&B Tes
• The WELLlife™ COVID-19 / Influenza A&B Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet the requirements to perform moderate, high or waived complexity tests
• This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
• Positive results do not rule out bacterial infection or co-infection with other viruses
• All negative results should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management
• Negative results do not rule out influenza or SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions such as isolating from others and wearing masks

More Information

• Welllife COVID-19 and FLU A+B FDA EUA
• Welllife COVID-19 and FLU A+B IFU
• Welllife COVID-19 and FLU A+B Healthcare Providers Fact Sheet
• Welllife COVID-19 and FLU A+B Patients Fact Sheet