Sensitivity analysis on colloidal gold immunochromatography assay kit in rapid antigen test of influenza A pandemic（H1N1） 2009 virus

doi:10.3969/j.issn.1673-8640.2013.02.018

Abstract

Abstract: Objective　To research the sensitivity of colloidal gold immunochromatography assay kit in rapid antigen test of influenza A pandemic（H1N1） 2009 virus. Methods　A total of 171 nasal-pharyngeal swabs were tested retrospectively by the colloidal gold immunochromatography assay kits，and the results determined by real-time fluorescence quantitative polymerase chain reaction（FQ-PCR） were as reference. Compared to the results of real-time FQ-PCR，the sensitivities of the 2 kits were then obtained at various courses of disease and virus RNA concentrations. Results　The sensitivities of the 2 kits had significantly positive correlation with virus RNA concentrations（P＜0.01），and reached both 73.3% when the virus RNA concentration was ≥108 copies/mL. The positive rates of the 2 kits showed significantly negative correlation with the courses of disease（P＜0.01），and were 66.7% and 62.5% respectively between 1 to 2 d after the symptoms appeared. Theoretical study demonstrated that the sensitivities would be 77.3% and 74.6%. Conclusions　The colloidal gold immunochromatography assay kit could provide early diagnostic efficacy of influenza A pandemic（H1N1） 2009 virus，and the feature is high virus concentration. It could be used in early diagnosis and screening test of massive specimens or field test for customs. Since the colloidal gold immunochromatography assay has some limitations，the results of the assay should be confirmed by PCR.

Key words: Influenza A pandemic（H1N1） 2009 virus, Rapid antigen test, Colloidal gold immunochromatography assay, Real-time fluorescence quantitative polymerase chain reaction

TIAN Di 1，HE Jing 1，LIU Yi 1，ZHANG Wanju 1，XU Lei 1，CHEN Gongxiang 2，ZHOU Zhitong 1，HU Yunwen 1. Sensitivity analysis on colloidal gold immunochromatography assay kit in rapid antigen test of influenza A pandemic（H1N1） 2009 virus[J]. , 2013, 28(2): 154-158.

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