Comparative Evaluation of Antigen Testing and Real-time PCR for Respiratory Pathogen Detection

Abstract

         This study evaluated the performance of the Standard F2400 test kit for detecting SARS-CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV) in clinical patient samples, compared with real-time PCR as the reference standard. For SARS-CoV-2, among 129 samples, 19 were true positive and 110 true negative. For Influenza A, 22 true positive and 104 true negative were observed from 126 samples. Influenza B testing of 132 samples yielded 22 true positive and 110 true negative, while RSV testing of 129 samples showed 22 true positive and 107 true negative. The F2400 kit demonstrated 100% sensitivity and specificity for all pathogens, with positive predictive value (PPV), negative predictive value (NPV), and accuracy all at 100%. Agreement between F2400 and RT-PCR was excellent, with Cohen’s kappa (K) of 1.000 for all pathogens; 95% confidence intervals of K ranged from 0.896–1.000 for SARS-CoV-2 and 0.906–1.000 for the other viruses. For other pathogens, no cross-reactivity was detected, suggesting that the Standard F2400 test kit can be used to detect all four pathogens. It is imperative that negative results be confirmed by nucleic acid testing to prevent severe consequences in patients with respiratory tract infection.