Protocol Description

The SARS-CoV-2 & Flu A/B Rapid Antigen Test is intended for use by healthcare professionals to rapidly differentiate between SARS-CoV-2 and influenza viruses A and B infections in individuals with symptoms consistent with COVID-19 or influenza. The single integrated combination test uses a nasopharyngeal swab specimen to produce qualitative results (“yes/no” answer) on the presence of SARS-CoV-2 and/or influenza A and/or B antigens in 15-30 minutes. The test has a relative sensitivity of 84.85% and specificity of 98.59% for SARS-CoV-2. For the flu, the test has a positive percent agreement of 81.16% (influenza virus A) and 100% (influenza virus B) against a molecular test, and relative specificity of 100% (influenza virus A) and 99.04% (influenza virus B).1 The currently available sequences of the Omicron variant SARS-CoV-2 (B.1.1.529) have been analyzed, and based on the initial in silico investigations, an impact on the performance of the test is not expected.


Eligibility Criteria

You may be eligible to participate in this study if you meet the following criteria:


  • Informed consent signed (and assent, if appropriate)
  • Age 14 or above
  • Sample collected within 7 days past symptom onset (DPSO)
  • Symptomatic patients ≤ 7 DPSO.
  • At least one of the following symptoms presented alone or in combination:
    • Cough
    • Shortness of breath or difficulty breathing
    • Fever or chills
    • Muscle or body aches


Clinical Trial Investigator

Dr. Jose David Suarez, Principal Investigator