两种国产甲型流感病毒抗原试剂检测2009H1N1流感病毒敏感性实验研究

Analytical Sensitivity of Two Rapid Flu-A Antigen Test Kit Made in China on 2009 Pandemic Influenza A（H1N1） Virus

目的评价两种国产甲型流感病毒抗原试剂盒检测2009H1N1流感病毒的敏感性。方法用这两种试剂检测已知病毒滴度和血凝素基因拷贝数的2009H1N1流感病毒毒株，计算试剂敏感性；同时与real—time RT PCR方法比较，探讨其临床应用。结果免疫渗滤法对2009H1N1流感病毒敏感性为2．58×10^5copies／ml，检测底线TCID50为10^2.33／ml；胶体金法为2．58×100^8copies／ml，TCID50为10^5.33／ml。对59份核酸阳性标本进行检测，免疫渗滤法34份阳性，胶体金法21份阳性，两种方法检出率比较差异有统计学意义（Х^2=5．76，P〈0．05）。结论免疫渗滤法虽然操作繁琐，但在对2009H1N1流感病毒进行检测时敏感性明显高于胶体金法。

Objective To evaluate the analytical sensitivity of two rapid flu-A antigen test kit made in China in detecting 2009 Pandemic Influenza A（H1N1） Virus. Methods To test the quantified 2009 Pandemic Influenza A（HIN1） Virus and real-time RT PCR confirmed clinical samples with these two kits. Results The assay limitation of dot ELISA was 2. 58 × 10^5copies/ml,TCID50 10^2. 33/ml,and the Colloidal gold immunization was 2.58 × 10^8copies/ml and TCID50 10^5.33/ml. For 59 2009 H1N1 nucleotide positive samples,dot ELISA detected 34 positive and Colloidal gold immunization 21 ,and two methods showed statistical significance（Х^2=5.76,P〈0. 05）. Conclusion The dot ELISA was more sensitive on testing of 2009 Pandemic Influenza A（H1N1） Virus.