title: [Evaluation of the efficacies of rapid antigen test, multiplex PCR, and real-time PCR for the detection of a novel influenza A (H1N1) virus].
abstract: 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 PCR assays have been developed to detect the H1N1 virus. We evaluated the efficacies of rapid antigen test, multiplex PCR, and real-time PCR 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 PCR (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 PCR and the AccuPower real-time PCR (Bioneer, Korea).
  
  
  RESULTS
  In comparison with the results of multiplex PCR, the sensitivity and specificity of the rapid antigen test were 48.0% and 99.8%, respectively. The concordance rate for multiplex PCR and the AdvanSure real-time PCR was 99.6% (kappa=0.991, P=0.000), and that for the AdvanSure real-time PCR and the AccuPower real-time PCR was 97.0% (kappa=0.936, P=0.000).
  
  
  CONCLUSIONS
  The rapid antigen test is significantly less sensitive than PCR assay; therefore, it is not useful for H1N1 detection; however multiplex PCR, the AdvanSure real-time PCR, and the Accu-Power real-time PCR can be useful for H1N1 detection.
authors.affiliation: Department of Laboratory Medicine, School of Medicine, Ewha Womans University, Seoul, Korea.
authors.forename: Yusun
authors.initials: Y
authors.lastname: Hwang
authors.forename: Kyounghee
authors.initials: K
authors.lastname: Kim
authors.forename: Miae
authors.initials: M
authors.lastname: Lee
mesh_terms: D000956:Antigens, Viral / Q000235:genetics; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D007251:Influenza, Human / Q000175:diagnosis* / Q000821:virology; D016133:Polymerase Chain Reaction; D012367:RNA, Viral / Q000235:genetics; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D017423:Sequence Analysis, RNA
chemical_list: D000956:Antigens, Viral; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic