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The WELLlife™ COVID-19 / Influenza A&B Home Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for nonprescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older. All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out influenza, SARS-CoV-2, or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider. Positive results do not rule out co-infection with other respiratory pathogens, and therefore do not subsitiute for a visit to a healthcare provider or appropriate follow-up. The WELLlife™ COVID-19 / Influenza A&B Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for use by individuals aged 14 years or older testing themselves, or adults testing aged 2 years or older. All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out influenza, SARS-CoV-2, or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and or shortness of breath, should seek follow-up care from their healthcare providers. Positive results do not rule out co-infection with other respiratory pathogens. Test results should not be used as the sole basis for treatment management decisions.

The WELLlife™ COVID-19 / Influenza A&B Home Test and the WELLlife™ COVID-19 / Influenza A&B Antigen Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. The test has two versions, one for over the counter (OTC) use, the (WELLlife™ COVID-19 / Influenza A&B Home Test), and one for professional use (WELLlife™ COVID-19 / Influenza Antigen A&B). Both versions of the WELLIife™ COVID-19 / Influenza A&B Tests that have an identical general design and are intended for the qualitative detection of nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with respiratory signs and symptoms within the first four (4) days of symptom onset. Results are for the identification and differentiation of nucleocapsid protein antigen from SARS-CoV-2, nucleoprotein antigen from influenza A virus, and nucleoprotein antigen from influenza B virus. The test cassette in the test kit is assembled with a test strip in a plastic housing that contains a nitrocellulose membrane with four lines: three test lines (Flu A line, Flu B line and CoV line) and a control line (C line). The device is for in vitro diagnostic use only. The device is for over-the-counter use.