人巨细胞病毒核酸定量检测试剂盒临床应用及初步评价王述莲;邓中平;呼建民;戴立忠;黄基容;王军;艾颖娟【摘要】目的：探讨人巨细胞病毒（HCMV）核酸定量检测试剂（PCR‐荧光探针法）的临床使用及初步评价。
方法：用浓缩一步法试剂与煮沸法试剂对192例临床收集的样本进行HCMVDNA检测并对比其结果，同时，将两种试剂的检测结果分别与HCMV‐pp65抗原检测结果进行对比。
结果：新型人巨细胞病毒核酸检测试剂与煮沸法试剂的阳性一致性百分比98．06％，阴性一致性百分比95．51％，总一致性百分比96．88％；对6例不符样本进行测序复核，并对复核后的结果进行Kap‐pa检验一致性分析，结果Kappa值＝1．000，表明新型试剂的检测结果与煮沸法试剂及复核检测的结果具有很好的一致性。
在与HCMV‐pp5抗原检测结果的对比中，两种试剂均表现出较好的准确性。
结论：人巨细胞病毒核酸检测试剂与煮沸法试剂检测结果具有很好一致性，操作简单快速，减少污染环节，并具有内标控制假阴性，结果准确，符合临床检测要求，具有较高的应用价值。
%Objective:The goal of this study is to evaluate the clinical application of a new Human Cyto‐megalovirus DNA Diagnostic Kit (refer to as concentrated one‐step method hereafter) .Methods:A total of 192 clinical specimens were detected by concentrated one‐step method and another kind of fluorescence diagnostic kit u‐sing boiling method ,The results were analyzed a nd compared .Simultaneously ,HCMV‐pp65 antigenemia test re‐sults of these 192 specimens were gathered and compared with the results from the one step and Boiling method kits . Results :The two kits showed excellent agreement The Positive consistency was 98 .06% ,the negative consistency was 95 .51% and the total consistency was 96 .88% ;6 cases ofdiscrepant samples were sequenced review ,then the results were performed with the Kappa consistency analysis ,The value ofKappa=1 .000 ,showed good consistency between the two methods .In addition ,compared with HCMV‐pp65 antigenemia test results ,the two reagents both showed good accuracy .Conclusion :The one step method showed good consistency compared with the conventional boiling method ,In this method ,the nucleic acid targets extracted by lysis buffer all went into the PCR reaction .This avoids laboratory contaminations which occur often during routine DNA extraction process .And the PCR detection system uses an internal positive control (internal control) to avoid a false negative result .With a simple procedure , precise results ,this new diagnostic kit is suitable for routine clinical lab usage .【期刊名称】《陕西医学杂志》【年(卷),期】2014(000)011【总页数】3页(P1542-1544)【关键词】巨细胞病毒感染;脱氧核糖酸酶类/分析;荧光免疫测定;聚合酶链式反应;试剂盒,诊断;煮沸法【作者】王述莲;邓中平;呼建民;戴立忠;黄基容;王军;艾颖娟【作者单位】武警北京市总队第三医院检验科北京100141;湖南圣湘生物科技有限公司;武警北京市总队第三医院检验科北京100141;湖南圣湘生物科技有限公司;武警北京市总队第三医院检验科北京100141;湖南圣湘生物科技有限公司;湖南圣湘生物科技有限公司【正文语种】中文【中图分类】R446人类巨细胞病毒（Human cytomegalovirus，HCMV）亦称细胞包涵体病毒，为疱疹病毒科β属的双螺旋DNA病毒，由于感染的细胞肿大，并具有巨大的核内包涵体，所以称为巨细胞病毒。
