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

• Published in: Frontiers in molecular biosciences 2024-05, Vol.11, p.1308202
• Main Authors: Rosenblatt, Kevin P, Romeu, Hugo, Romeu, Camille, Granger, Elder
• Format: Article
• Language: English
• Subjects: coronavirus; COVID-19; influenza; Molecular Biosciences; point-of-care testing; rapid antigen test
• ISSN: 2296-889X; 2296-889X
• DOI: 10.3389/fmolb.2024.1308202

The global COVID-19 pandemic and seasonal influenza outbreaks have drawn attention to the critical need for accurate and efficient diagnostic tools. 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. 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 to 7.05 × 10 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. 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.