Clinical Evaluating the Accuracy of the Panbio™ COVID-19/Flu A&B Rapid Panel, a Combo Antigen Rapid Diagnostic Test for the Omicron Variant and Influenza A Virus

It is difficult to differentiate between coronavirus disease 2019 (COVID-19) and influenza based on symptoms. In the present study, a newly developed antigen rapid diagnostic test (Ag-RDT) called PanbioTM COVID-19/Flu A&B that can simultaneously detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A/B virus was evaluated. Furthermore, its accuracy was evaluated using 235 pairs of nasopharyngeal samples collected from patients with respiratory symptoms and fever (>37.5°C). Reverse transcription polymerase chain reaction was used as a reference method to evaluate the accuracy of SARS-CoV-2 detection. We confirmed the accuracy of the developed Ag-RDT against the Omicron variant, including BA.2 and BA.5. The sensitivity was 94.8% and specificity was 100%. In addition, to identify the influenza A virus, a noninferiority test was conducted using a commercial Ag-RDT, which has already confirmed high sensitivity and specificity in comparison with viral culture (sensitivity, 94.8%; specificity, 98.4%). The positive and negative predictive values for influenza A virus were 98.5% and 98.1%, respectively. The accuracy of the newly developed PanbioTM COVID-19/Flu A&B, which was evaluated using clinical samples, suggests that it has high efficacy in clinical settings.