For Emergency Use Authorization (EUA) only* | For in vitro diagnostic use

WELLlife™ COVID-19 / Influenza A&B Test utilizes advanced immunoassay technology to quickly and accurately differentiate between SARS-CoV-2, influenza A, and influenza B with a single nasal swab. Recommended for rapid diagnostics, this test is an essential tool for timely management of viral infections, supporting swift treatment decisions during the flu season and amidst public health concerns.

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. 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.

ACCURACY:

SARS-CoV-2

Positive Percent Agreement (PPA) = 87.5%

Negative Percent Agreement (NPA) = 99.7%

Limit of Detection (TCID₅₀/mL)** = 7.90 x10²

Influenza A

Positive Percent Agreement (PPA) = 85.9%

Negative Percent Agreement (NPA) = 99.7%

Limit of Detection (TCID₅₀/mL)** = 1.01 x10²

Influenza B

Positive Percent Agreement (PPA) = 86.8%

Negative Percent Agreement (NPA) = 99.7%

Limit of Detection (TCID₅₀/mL)** = 5.85 x10²

KEY BENEFITS:

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: available in 10 minutes allows for testing and treatment decision-making during the same office visit.

QUALITY ASSURANCE: The outstanding clinical performance, including built-in kit controls for external quality testing, enables physicians to make quicker and more confident decisions.

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.

WIDE STORAGE TEMPERATURE: 36°F-86°F (2°C-30°C) allows for easier product storage.

NUMBER OF TESTS: 25

CPT CODE(S): 87811QW (COVID-19), 87804QW (Flu A), 87804QW-59 (Flu B)

COMPONENTS IN 1 KIT:

25 WELLlife™ COVID-19 / Influenza A&B test cassettes

25 Prefilled extraction buffer tubes

25 Sterile swabs

1 Positive control swab

1 Negative control swab

1 Tube holder

1 Package Insert

1 Quick Reference Instructions

DOCUMENTATION:

WELLlife COVID-19 Influenza A&B POC Package Insert

WELLlife COVID-19 Influenza A&B POC Quick Reference Instruction

WELLlife COVID-19 Influenza A&B POC Patient Fact Sheet

WELLlife COVID-19 Influenza A&B POC HCP Fact Sheet

*In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/ or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

** LOD for Influenza A A/Victoria/4897/2022(H1N1), LOD for Influenza B B/Florida/4/2006(Yamagata). Please refer to Package Insert for more detailed information

Thank You!