Objective To assess the value of combined detection of enterovirus nucleic acid and antibody in early etiological diagnosis for hand-foot-and-mouth disease ( HFMD).Methods A case-control study was conducted.A total of 1 066 cases of children clinically diagnosed with HFMD from Hangzhou Children′s Hospital were involved into the research group from January to June 2014, consisting of 401 common cases and 665 severe cases; Throat swabs and serum samples from these children underwent combined detection for EV71/CA16/EV of enterovirus nucleic acid by fluorescence quantitative RT-PCR and for EV71/CA16-IgM by ELISA.All data were analyzed with SPSS 16.0.Results The total positive rate of enterovirus nucleic acid EV71/CA16/EV by fluorescence quantitative RT-PCR in the 1 066 cases of children clinically diagnosed with HFMD was 75.52%( 805/1 066 ) ( 95%CI: 72.80%-78.05%).But the total positive rate of combined detection was 91.46%( 975/1 066 ) ( 95%CI:89%.58-93.04%).The total positive rate of combined detection is higher than that of RT-PCR test(χ2 =98.338,P=0.000).The positive rate of EV71 type of combined detection was 64.63%(689/1 066)(95%CI:61.67%-67.49%),which is 15.38%higher than that of RT-PCR test 49.25%(525/1 066)(95%CI:46.21%-52.29%)(χ2 =51.453, P=0.000).In 665 severe cases of HFMD, the total positive rate of combined detection was 96.69%(643/665)(95%CI:94.95%-97.87%), which is higher than that of RT-PCR test 79.25%(527/665)(95%CI:75.92%-82.22%)(χ2 =95.607, P =0.000).In the severe cases, the positive rate of EV71 type of combined detection was 87.52%( 582/665 ) ( 95%CI:84.71%-89.89%) , which is 18.95% higher than that of RT-PCR test 68.57%(456/665) (95%CI:64.87%-72.06%) (χ2 =69.665, P=0.000).In the fatal cases, the positive rate of EV71 type of combined detection was 95.92%(94/98) (95%CI:89.28%-98.68%).Conclusions The combined detection of enterovirus nucleic acid and specific IgM antibody can significantly increase the positive rate of HFMD, especially for severe cases.The combine detection increases both the total positive rate and EV71 positive rate.Thus it has a high potential for becoming a new guidelines for laboratory diagnosis of HFMD.%目的：探讨肠道病毒核酸与特异性抗体联合检测在手足口病实验室早期诊断中的应用价值，为手足口病患儿实验室诊断提供新参考。方法病例对照研究。收集杭州市儿童医院2014年1至6月1066例临床诊断手足口病的住院患儿，其中普通病例401例，重症病例665例。对上述住院患儿同时采集咽拭子和血清样本进行肠道病毒核酸EV71／CA16／EV通用型实时荧光定量RT-PCR与EV71／CA16-IgM抗体联合检测。采用SPSS16.0软件进行组间χ2检验或McNemarχ2检验统计分析。结果1066例手足口病临床诊断病例中肠道病毒核酸EV71／CA16／EV通用型实时荧光定量RT-PCR检测总阳性率为75.52％（805／1066）（95％CI：72.80％～78.05％）；肠道病毒核酸联合EV71／CA16-IgM抗体检测总阳性率为91.46％（975／1066）（95％CI：89.58％～93.04％），总阳性率比较差异有统计学意义（χ2＝98.338，P＝0.000）。单纯肠道病毒核酸检测EV71型检出率为49.25％（525／1066）（95％CI：46.21％～52.29％），联合检测 EV71型检出率为64.63％（689／1066）（95％CI：61.67％～67.49％），EV71阳性检出率比较差异有统计学意义（χ2＝51.453， P＝0.000）。665例临床诊断为重症手足口病病例中，肠道病毒核酸抗体联合检测总阳性率为96.69％（643／665）（95％CI：94.95％～97.87％），与单纯肠道病毒核酸检测总阳性率79.25％（527／665）（95％CI：75.92％～82.22％）比较差异有统计学意义（χ2＝95.607， P＝0.000）；重症病例中，联合检测EV71阳性率为87.52％（582／665）（95％CI：84.71％～89.89％），单纯核酸检测为68.57％（456／665）（95％CI：64.87％～72.06％），EV71阳性率提高了18.95％（126／665），两者比较差异有统计学意义（χ2＝69.665， P＝0.000）。结论肠道病毒核酸与特异性抗体联合检测可以显著提高手足口病实验室诊断检出率，尤其对于重症手足口病患儿，联合检测总阳性率与EV71阳性率显著提高，具有较高的临床诊断应用价值，有望成为手足口病实验室诊断的新方案。（中华检验医学杂志，2015，38：397-401）
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