Korean J Lab Med.  2010 Apr;30(2):147-152. 10.3343/kjlm.2010.30.2.147.

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

Affiliations
  • 1Department of Laboratory Medicine, School of Medicine, Ewha Womans University, Seoul, Korea. miae@ewha.ac.kr

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.

Keyword

Novel influenza A (H1N1) virus; Rapid antigen test; Multiplex PCR; Real-time PCR

MeSH Terms

Antigens, Viral/genetics
Humans
Influenza A Virus, H1N1 Subtype/genetics/immunology/*isolation &purification
Influenza, Human/*diagnosis/virology
*Polymerase Chain Reaction
RNA, Viral/genetics
Reagent Kits, Diagnostic
Sensitivity and Specificity
Sequence Analysis, RNA

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Reference

1.WHO. World now at the start of 2009 influenza pandemic. http://www.who.int/mediacentre/news/statements/2009/h1n1_pandemic_phase6_20090611/en/. (Updated on Jun. 2009.
2.Peiris JS., Poon LL., Guan Y. Emergence of a novel swine-origin influenza A virus (S-OIV) H1N1 virus in humans. J Clin Virol. 2009. 45:169–73.
3.WHO. Assessing the severity of an influenza pandemic. http://www.who.int/csr/disease/swineflu/assess/disease_swineflu_assess_20090511/en/index.html. (Updated on May. 2009.
4.WHO. WHO information for laboratory diagnosis of pandemic (H1N1) 2009 virus in humans-revised. http://www.who.int/csr/resources/publications/swineflu/WHO_Diagnostic_RecommendationsH1N1_20090521.pdf. (Updated on Nov. 2009.
5.Pabbaraju K., Wong S., Wong AA., Appleyard GD., Chui L., Pang XL, et al. Design and validation of real-time reverse transcription-PCR assays for detection of pandemic (H1N1) 2009 virus. J Clin Microbiol. 2009. 47:3454–60.
Article
6.National Center for Biotechnology Information (NCBI). Sequences from pandemic (H1N1) 2009 viruses. http://www.ncbi.nlm.nih.gov/genomes/FLU/FLU.html. (Updated on Nov. 2009.
7.Centers for Disease Control and Prevention (CDC). Evaluation of rapid influenza diagnostic tests for detection of novel influenza A (H1N1) Virus-United States, 2009. MMWR Morb Mortal Wkly Rep. 2009. 58:826–9.
8.Vasoo S., Stevens J., Singh K. Rapid antigen tests for diagnosis of pandemic (Swine) influenza A/H1N1. Clin Infect Dis. 2009. 49:1090–3.
Article
9.Ginocchio CC., Zhang F., Manji R., Arora S., Bornfreund M., Falk L, et al. Evaluation of multiple test methods for the detection of the novel 2009 influenza A (H1N1) during the New York City outbreak. J Clin Virol. 2009. 45:191–5.
Article
10.Petric M., Comanor L., Petti CA. Role of the laboratory in diagnosis of influenza during seasonal epidemics and potential pandemics. J Infect Dis. 2006. 194(S2):98–110.
Article
11.Ge Y., Cui L., Qi X., Shan J., Shan Y., Qi Y, et al. Detection of novel swine origin influenza A virus (H1N1) by real-time nucleic acid sequence-based amplification. J Virol Methods. 2010. 163:495–7.
Article
12.LeBlanc JJ., Li Y., Bastien N., Forward KR., Davidson RJ., Hatchette TF. Switching gears for an influenza pandemic: validation of a duplex reverse transcriptase PCR assay for simultaneous detection and confirmatory identification of pandemic (H1N1) 2009 influenza virus. J Clin Microbiol. 2009. 47:3805–13.
Article
13.Poon LL., Chan KH., Smith GJ., Leung CS., Guan Y., Yuen KY, et al. Molecular detection of a novel human influenza (H1N1) of pandemic potential by conventional and real-time quantitative RT-PCR assays. Clin Chem. 2009. 55:1555–8.
Article
14.Whiley DM., Bialasiewicz S., Bletchly C., Faux CE., Harrower B., Gould AR, et al. Detection of novel influenza A(H1N1) virus by real-time RT-PCR. J Clin Virol. 2009. 45:203–4.
Article
15.He J., Bose ME., Beck ET., Fan J., Tiwari S., Metallo J, et al. Rapid multiplex reverse transcription-PCR typing of influenza A and B virus, and subtyping of influenza A virus into H1, 2, 3, 5, 7, 9, N1 (human), N1 (animal), N2, and N7, including typing of novel swine origin influenza A (H1N1) virus, during the 2009 outbreak in Milwaukee, Wisconsin. J Clin Microbiol. 2009. 47:2772–8.
Article
16.Carr MJ., Gunson R., Maclean A., Coughlan S., Fitzgerald M., Scully M, et al. Development of a real-time RT-PCR for the detection of swine-lineage influenza A (H1N1) virus infections. J Clin Virol. 2009. 45:196–9.
Article
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