两种新生儿巨细胞病毒IgG抗体筛查的ELISA试剂盒的比较研究  

The comparison of two newborn cytomegalovirus IgG antibody screening ELISA kits

作　　者：张顺先 何小周 王世文 王晓芳 

机构地区：[1]北京中国疾控预防控制中心病毒病预防控制所,102206

出　　处：《中华实验和临床病毒学杂志》2013年第5期392-394,共3页Chinese Journal of Experimental and Clinical Virology

基　　金：中美新发再发传染病项目（巨细胞病毒项目）

摘　　要：目的对两种用于新生儿巨细胞病毒IgG抗体筛查的ELISA试剂盒进行比较，对Abnova试剂盒的检测性能进行评价。方法采集488份新生儿足跟血干血片样品，分别用SeraQuest试剂盒和Abnova试剂盒进行检测CMVIgG抗体。比较二者在不同样品稀释浓度下的检测能力，继而以性能得到公认的SeraQuest试剂盒结果为金标准，通过统计学方法得到Abnova试剂盒的相关检测指标。结果两种试剂盒在其说明书要求的样品浓度下检测能力接近，但在样品稀释以后，SeraQuest试剂盒检测能力更强。Abnova试剂盒相对于SeraQuest试剂盒的灵敏度为98．3％，特异度为89．3％，阳性预测值为99．3％，阴性预测值为75．7％，两种方法总的符合率为97．7％。Abnova试剂盒ROC曲线下面积为0．808，对结果准确性的判断与SeraQuest试剂盒高度一致。结论Abnova试剂盒适用于先天性CMV的IgG筛查，但在实际工作中应对结果为模糊的样品进行重复测试，以提高其特异度和阴性预测值。Objective This study compared two newborn Cytomegalovirus （CMV） lgG antibody screening ELISA kits and evaluated the detection effectiveness of Abnova kit. Methods CMV IgG antibodies were detected by both SeraQuest and Abnova kits from dried blood spot （DBS） samples of 488 newborn heel sticks. The detection abilities of these two kits were compared in different sample dilution concentrations. Relative detection effectiveness of the Abnova kit was defined by statistical method using the SeraQuest kit as a point of comparison. Result Compared to the SeraQuest screening test kit, the Abnova kit revealed a sensitivity of 98, 9% , specificity of 78.6% , positive predictive value of 99.3% , negative predictive value of 68.8% , and the coincidence rate for these two screening test kits at 98.3%. The consistency check of both kits based on interpretation of the kappa statistic was relatively good. For the Abnova kit, the ＂area under the ROC curve＂ was 0. 887, which indicates moderate accuracy. Conclusion Abnova kit can be applied to newborn screening for congenital CMV infections. However, repeating the test for ambiguous results is suggested to increase the specificity and negative predictive value.

关 键 词：婴儿 新生 巨细胞病毒感染 酶联免疫吸附测定 

分 类 号：R446.6[医药卫生—诊断学]