AUTHOR=Rosenblatt Kevin P. , Romeu Hugo , Romeu Camille , Granger Elder 

TITLE=Performance evaluation of a SARS-CoV-2 and influenza A/B combo rapid antigen test

JOURNAL=Frontiers in Molecular Biosciences

VOLUME=11

YEAR=2024

URL=https://www.frontiersin.org/journals/molecular-biosciences/articles/10.3389/fmolb.2024.1308202

DOI=10.3389/fmolb.2024.1308202

ISSN=2296-889X

ABSTRACT=<p><bold>Introduction:</bold> The global COVID-19 pandemic and seasonal influenza outbreaks have drawn attention to the critical need for accurate and efficient diagnostic tools.</p><p><bold>Methods:</bold> The performance of the InstaView COVID-19/Flu Ag Combo Test, which was designed to simultaneously detect the SARS-CoV-2, influenza A, and influenza B viruses, was analytically and clinically evaluated.</p><p><bold>Results:</bold> The InstaView COVID-19/Flu Ag Combo Test exhibited robust detection capabilities, accurately identifying SARS-CoV-2, influenza A, and influenza B viruses over a wide concentration range (1.41 × 10<sup>3</sup> to 7.05 × 10<sup>4</sup> TCID50/mL). Extensive testing against potential cross-reactants and interferences yielded no false-positive results, indicating the high specificity of the test. Clinical evaluation further confirmed the kit’s reliability, with sensitivity ranging from 95.1% to 98.2% for SARS-CoV-2, 88.9%–95.2% for influenza A, and 91.7%–100% for influenza B depending on the sample type. The specificity was consistently 100% for all of the targeted viruses.</p><p><bold>Discussion:</bold> The InstaView COVID-19/Flu Ag Combo Test thus demonstrated high performance, ease of use, rapid results, and the ability to precisely detect SARS-CoV-2 and influenza A/B infections, making it an effective tool in streamlining diagnostic workflows, optimizing resource allocation, and improving patient outcomes.</p>