Evaluation of the Efficacies of Rapid Antigen Test, Multiplex PCR, and Real-time PCR for the Detection of a Novel Influenza A (H1N1) Virus

Background : In April 2009, a novel influenza A (H1N1) virus was detected in the US, and at the time of conducting this study, H1N1 infection had reached pandemic proportions. In Korea, rapid antigen tests and FOR assays have been developed to detect the H1N1 virus. We evaluated the efficacies of rapid antigen test, multiplex FOR, and real-time FOR for detecting the H1N1 virus. Methods : From August to September 2009, we tested 734 samples obtained from nasopharyngeal swab or nasal swab using rapid antigen test (SD Influenza Antigen, Standard Diagnostics, Inc., Korea) and multiplex PCR (Seeplex FluA ACE Subtyping, Seegene, Korea). We also tested 224 samples using the AdvanSure real-time FOR (LG Life Sciences, Korea) to compare the results obtained using real-time PCR with those obtained using multiplex PCR. Furthermore, 99 samples were tested using the AdvanSure real-time FOR and the AccuPower real-time FOR (Bioneer, Korea). Results : In comparison with the results of multiplex FOR, the sensitivity and specificity of the rapid antigen test were 48.0% and 99.8%, respectively. The concordance rate for multiplex FOR and the AdvanSure real-time FOR was 99.6% (kappa=0.991, P=0.000), and that for the AdvanSure real-time FOR and the AccuPower real-time FOR was 97.0% (kappa=0.936, P=0.000). Conclusions : The rapid antigen test is significantly less sensitive than FOR assay; therefore, it is not useful for H1N1 detection; however multiplex FOR, the AdvanSure real-time FOR, and the AccuPower real-time FOR can be useful for H1N1 detection. (Korean J Lab Med 2010;30: 147-52)