WELLlife™ COVID-19 / Influenza A&B Test
A reliable and cost-effective solution, the COVID-19 / Influenza A&B Test is an essential tool for timely management of viral infections.
- FDA EUA240004
- For Emergency Use Authorization (EUA) Only
- For In Vitro Diagnostic Use
- For Use with Anterior Nasal Swab Specimens
About
The ability to quickly and accurately differentiate between COVID-19 and flu symptoms is more crucial than ever. This innovative Combo COVID-19 and Flu POC Test empowers providers with a convenient and reliable solution for in-clinic testing.
Features
- Rapid Results, Batch Testing: Quick and easy workflow with results in just 10 minutes.
- Extended Detection Window: Offers a broader detection window for differentiation of SARS-COV-2, influenza A, and influenza B antigens within five days of symptom onset.
- Quality Assurance: The outstanding clinical performance, including built-in kit controls for external quality testing, enables physicians to make quicker and more confident decisions.
- Reliable: With a COVID-19 clinical sensitivity of 87.5%, Flu A clinical sensitivity of 85.9% and Flu B clinical sensitivity of 86.8%, this combo test allows users to accurately differentiate between COVID-19, Flu A, and Flu B.
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Specifications
| Product Code | EUA240004 |
|---|---|
| Items Per Box | 25 |
| Specimen Type | Nasal Swab |
| Result Time | 10 Minutes |
| Clinical Sensitivity | COVID - 87.5%, FLU A - 85.9%, FLU B - 86.8% |
| Test Components | Individually packaged test cassettes, Test casettes, Prefilled extraction buffer, Sterile swabs, Positive control swab, Negative control swab, Tube holder, Package insert, Quick Reference Instruction |
Intended Use
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. Clinical
signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be
similar. 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.
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