Respiratory Test Kit WELLlife™ COVID-19 / Flu A + B Test 25 Tests

Features

• WELLlife™ COVID-19 / Influenza A&B 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 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 indicate the presence of viral antigens, but the 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
• 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
• Cost-effective: Differentiate between SARS-COV-2, influenza A, and influenza B antigens with a single test using an anterior nasal swab specimen
• Rapid Results: Results are available in 10 minutes allowing for testing and treatment decision-making during the same office visit
• 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
• Wide storage temperature: 36°F-86°F (2°C-30°C) allowing for easier product storage

More Information

• WELLlife COVID-19 / Flu A + B Test FDA EUA Lettter
• WELLlife COVID-19 / Flu A + B Test IFU
• WELLlife COVID-19 / Flu A + B Test Healthcare Providers Fact Sheet
• WELLlife COVID-19 / Flu A + B Patients Fact Sheet