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 and 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 of discrepant samples were sequenced review ,then the results were performed with the Kappa consistency analysis ,The value of Kappa=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 .
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