Development of a Specific and Rapid Diagnostic Method for Detecting Influenza A (H1N1) pdm09 Virus Infection Using Immunochromatographic Assay

Mi Jung Ji; Byung Ki Cho; Young Shik Cho; Young Jin Choi; Donghyok Kwon; Kyeongcheol Shin; Joo-Yeon Lee; Chun Kang; Byoung Su Yoon

doi:10.1016/j.phrp.2013.10.006

Development of a Specific and Rapid Diagnostic Method for Detecting Influenza A (H1N1) pdm09 Virus Infection Using Immunochromatographic Assay

Osong Public Health Res Perspect. 2013 Dec;4(6):342-6. doi: 10.1016/j.phrp.2013.10.006. Epub 2013 Nov 7.

Authors

Mi Jung Ji¹, Byung Ki Cho², Young Shik Cho², Young Jin Choi³, Donghyok Kwon⁴, Kyeongcheol Shin⁴, Joo-Yeon Lee⁴, Chun Kang⁴, Byoung Su Yoon⁵

Affiliations

¹ Biotech Laboratory, Standard Diagnostics Inc., Yongin, Korea ; Department of Life Science, College of Natural Science, Kyonggi University, Suwon, Korea.
² Biotech Laboratory, Standard Diagnostics Inc., Yongin, Korea.
³ Department of Laboratory Medicine, College of Medicine, Soonchunhyang University, Cheonan, Korea.
⁴ Division of Influenza Virus, Korea National Institute of Health, Osong, Korea.
⁵ Department of Life Science, College of Natural Science, Kyonggi University, Suwon, Korea.

Abstract

Objectives: The aim of this study was to develop an immunochromatographic assay (ICA) for the detection of influenza A (H1N1) pdm09 virus infection.

Materials and methods: Several monoclonal antibodies against influenza A (H1N1) pdm09 virus were generated and an ICA (pdm09-ICA) was developed for the rapid and specific detection of influenza A (H1N1) pdm09 virus infection. The specificity and sensitivity of the developed assay were compared with that of hemagglutination assay and real-time reverse-transcription polymerase chain reaction (rRT-PCR).

Results: The detection limit was estimated to be 1/2 (8) hemagglutinating unit; the sensitivity and specificity rates of pdm09-ICA were 75.86% (110/145) and 100% (43/43), respectively, compared with rRT-PCR. The cross-reactivity for 20 influenza viruses, including seasonal H1N1 viruses, was found to be negative except for the H1N1 virus (A/Swine/Korea/GC0503/2005).

Conclusion: These results indicate that the proposed method can be easily used for rapid and specific detection of the pdm09 infection. The assay developed in this study would be a useful tool for distinguishing the pdm09 infection from seasonal influenza A and B infections.

Keywords: immunochromatographic assay; immunochromatography test; influenza; pdm09.