115例急性呼吸道感染患者FluA抗原快速检测与血清抗体对比研究

Rapid detection on influenza virus A antigens in 115 cases of respiratory infections and comparative studies on paired serum antibody

目的评价胶体金免疫层析(gold immunochromatographic assay,GICA)快速检测甲型流感(influenza A,FluA)病毒抗原的可行性,并调查部分呼吸科住院患者FluA感染及抗体水平。方法收集2009年09月16日至2011年02月01日期间在北京军区总医院呼吸科住院的115例患者鼻咽部分泌物标本,应用GICA法检测FluA病毒抗原,同时留取患者双份血清。以检测双份血清抗体的HI法为"金标准",对GICA法做出评价。结果①GICA法与HI法检测结果行一致性检验,Kappa值为0.628,配对χ2检验,差异无统计学意义(P>0.05);GICA法的敏感度为68.2%,特异度为93.5%,符合率为84.3%,误诊率为6.5%,漏诊率为31.8%,约登指数是0.617;②115例住院患者FluAHI法确诊病例共22例,FluA(新型H1N1)检出率为4.3%(5/115),FluA(季节性H1N1)检出率为2.6%(3/115),FluA(季节性H3N2)检出率为6.1%(7/115),FluA混合感染检出率为6.1%(7/115)。FluA(新型H1N1)检出时间主要集中在09年10月和11月,随后以混合感染形式与FluA(季节性H3N2和H1N1)散发存在。结论①与HI法相比,应用GICA法检测FluA抗原,敏感度略低,特异度较好,二者一致性较好,作为临床筛查FluA感染有一定价值;②初步印证WHO预计的2009年H1N1流感病毒会在未来数年内以季节性病毒的方式继续传播趋势。

Objective To evaluate the value of gold immunochromatographic assay （GI- CA） for early screening for influenza in clinical investigations, and invcestigate influenza infection and antibody levels in hospitalized patients. Methods Districting from September 16, 2009 to February 1, 2011, GICA was utilized to rapidly detect the FluA antigen in the oral pharynx secre- tion of 115 patients in the department of respiratory in the General Hospital of Beijing Military. Then collected 115 paired serum samples, and evaluate GICA method according to the paired serum HI antibody method as＂ gold standard method＂. Results （1）Consistency checking was carried out on the results from GICA and paired serum detection, Kappa value was 0. 682 and the P value in thepaired X2 test was higher than 0.05, and the difference was not statistically significant; the sensitiv- ity of GICA was 68.2% ; the specificity was 93.5% ;the coincidence was 84.3% ;misdiagnosis rate was 6.5% ; omission diagnose rate was 31.8%. Youden index was 0. 617 ; （2）Confirmed cases of FluA by HI method were 22 cases, FluA （novel H1N1 ） detection rate was 4.3% （5 / 115）, FluA （H1N1） detection rate was 2.6% （3 / 115）, FluA （H3N2） detection rate was 6. 1% （7 / 115 ）, FluA mixed infection rate 6.1% （7/115 ）. FluA （novel H1 N1 ） detection time was mainly in Octobetor to December 2009,it exisited as mixed infection with FluA （H3N2 and H1N1 ）. Conclu- sion （3）Compared with HI method , the sensitivity for FluA antigen detection by using GICA was relatively low, the specificity was relatively satisfactory, the consistency of these two kinds of methods were relatively good. And it has certain values in the clinical screening for FluA infection;（4） WHO is expected to initially verify the 2009 H1N1 influenza virus in the next few years following the way that the virus continues to spread seasonal trends.