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目的:探讨微粒子酶免疫荧光分析(MEIA)法检测患儿血清中CMV-IgM在巨细胞病毒(CMV)感染患儿诊断上的应用价值。方法:应用MEIA法与固相酶免疫分析(ELISA)法检测了211例患儿血清中CMV-IgM,同时应用荧光定量PCR(FQ-PCR)检测患者尿液中CMV-DNA与流式细胞术检测患者全血白细胞表面CMV-PP65抗原,对各方法的敏感性、特异性、准确性进行对比分析。结果:211例疑似CMV感染患儿MEIA法CMV-IgM、ELISA法CMV-IgM、CMV-PP65、CMV DNA等相关指标的阳性率分别为37.91%、33.94%、35.29%、42.08%,经统计学分析四种方法检测的相关指标的阳性率没有显著差别(χ2=3.775,P>0.05)。211例标本中可确诊CMV感染病例为149例,占总数的70.62%。以FQ-PCR检测患者尿液中CMV-DNA作为“金标准”比较MEIA法CMV-IgM、ELISA法CMV-IgM、CMV-PP65三种方法的临床诊断敏感度分别为57.0%、55.9%、34.4%,特异性分别为77.1%、80.5%、61.0%,准确性分别为68.2%、69.7%、49.3%。CMV-DNA阳性组与阴性组的MEIA法CMV-IgM、ELISA法CMV-IgM两种方法检测指标阳性率比较经统计学分析差别有统计学意义(χ2=25.70,30.12,P<0.05)。CMV-DNA阳性组与阴性组的CMV-PP65阳性率比较经统计学分析差别无统计学意义(χ2=0.467,P>0.05)。结论:采用几种方法联合检测CMV感染,可以大大提高检出率与诊断率。MEIA法检测CMV-IgM为全自动操作,可保证各次实验条件一致,误差相对较小,可以定量快速单样本检测,提高了实验的精密度与准确性,结果可靠。认为MEIA法是目前最新最理想的CMV-IgM检测方法,值得临床广泛应用与推广。
Objective: To investigate the diagnostic value of CMV-IgM in children with cytomegalovirus (CMV) infection by using microparticle enzyme immunofluorescence assay (MEIA). Methods: CMV-IgM in serum of 211 children were detected by MEIA and enzyme-linked immunosorbent assay (ELISA). CMV-DNA in urine was detected by fluorescence quantitative PCR (FQ-PCR) and flow cytometry The detection of CMV-PP65 antigen on the whole blood leukocyte of patients, the sensitivity, specificity and accuracy of each method were compared. Results: The positive rates of CMV-IgM, CMV-IgM, CMV-PP65 and CMV DNA in 211 children with suspected CMV infection were 37.91%, 33.94%, 35.29% and 42.08% There was no significant difference in the positive rates of the four indicators (χ2 = 3.775, P> 0.05). Of the 211 specimens, 149 cases were diagnosed as CMV infection, accounting for 70.62% of the total. The diagnostic sensitivity of CMV-Ig in CMV-IgM and CMV-PP65 was 57.0% and 55.9% respectively compared with CMV-IgM of MEIA method and CMV-IgM of CMV-IgM and CMV- , 34.4% respectively, the specificity was 77.1%, 80.5% and 61.0%, respectively. The accuracy was 68.2%, 69.7% and 49.3% respectively. CMV-DNA positive group and negative group MEIA method CMV-IgM, ELISA method CMV-IgM two methods of detection of positive rate of the two indicators by statistical analysis, the difference was statistically significant (χ2 = 25.70,30.12, P <0.05). The positive rate of CMV-PP65 in CMV-DNA positive group and negative group was not statistically significant (χ2 = 0.467, P> 0.05). Conclusion: The combination of several methods to detect CMV infection can greatly improve the detection rate and diagnosis rate. The detection of CMV-IgM by MEIA method is a fully automatic operation, which ensures that the experimental conditions are the same and the error is relatively small. It can quantify the rapid single sample test and improve the precision and accuracy of the experiment with reliable results. That the MEIA method is the latest and most ideal CMV-IgM detection method, it is widely used in clinical and promotion.