Specification

Not Available for Sales in the US

Independent Evaluation by Authorities and Third Parties

• COVID-19 Testing Project, USA 
  A total of 10 commercially available serological tests are evaluated by a group of researchers and physicians at UCSF, UC Berkeley, Chan Zuckerberg Biohub and Innovative Genomics Institute.
• University Hospitals Leuven, Leadlife B.V., KU Leuven, Belgium 
  Diagnostic Performance of 7 Rapid IgG/IgM antibody tests and the Euroimmun IgA/IgG ELISA in COVID-19 patients.
• Health Science Agency, Singapore Government 
• Therapeutic Goods Administration (TGA), Department of Health, Australian Government 
• Foundation for Innovative New Diagnostics (FIND)

**Warning**

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NOT FOR AT-HOME TESTING.

The VivaDiag™ SARS-CoV-2 IgM/IgG Rapid Test (COVID-19 IgM/IgG Rapid Test) has ONLY been designed to act as a supplementary test for suspected cases of negative coronavirus nucleic acid detection or in conjunction with nucleic acid detection in the diagnosis of suspected cases. Results from IgM/IgG antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection or to inform infection status.

VivaDiag™ SARS-CoV-2 IgM/IgG Rapid Test (COVID-19 IgM/IgG Rapid Test) IS INTENDED FOR USE BY HEALTHCARE PROFESSIONALS AND CLINICAL LABS ONLY. DO NOT SEPARATE TEST COMPONENTS. IMPROPER USE MAY PRODUCE INVALID AND/OR UNRELIABLE TEST RESULTS.

DO NOT USE IF PACKAGE SEAL HAS BEEN REMOVED OR BROKEN.