Features

• WELLlife™ COVID-19 / Influenza A&B Home Test is for use under an FDA EUA: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
• WELLlife™ COVID-19 / Influenza A&B Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens
• This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals aged two (2) years or older
• This test is only authorized for 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
• Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
• Positive results do not rule out bacterial infection or co-infection with other viruses; the agent detected may not be the definitive cause of disease
• Individuals who test positive with the WELLlife™ COVID-19 / Influenza A&B Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary
• All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed
• The WELLlife™ COVID-19 / Flu A&B Home Test differentiates between COVID-19, influenza A and influenza B viruses with a single nasal swab, providing peace of mind without a healthcare visit
• Ease of use: Differentiate between SARS-COV-2, influenza A, and influenza B antigens with an easy nasal swab
• Up-to-Date Variant Detection: Detects multiple COVID-19 variants, including Omicron and the new XEC variant, as well as avian influenza (bird flu)
• Extended Detection Window: Offers a broader detection window for differentiation of SARS-COV-2, influenza A, and influenza B antigens within four days of symptom onset
• Rapid Results: Accurate and reliable results are available in just 10 minutes
• Suitable For Ages 2 and Above: The test can be used independently by individuals aged 14 years or older; adult collection is required for testing children 2-14 years old

Product Specifications