某国产HIV-1核酸定量检测试剂盒的应用性能评估

目的：对某国产人类免疫缺陷病毒Ⅰ型（HIV-1）核酸定量检测试剂盒（PCR-荧光探针法）的临床应用性能进行评估。方法收集不同H IV感染状态人群的血液样品共计247例，分别使用 H IV-1被评估试剂与已被SFDA批准的对照试剂进行临床检验平行对比。比较两种方法之间的相关性和一致性。对比不符样本用国际公认的Roche公司生产的 HIV-1病毒载量检测试剂进行复核。结果共检测247例样本，被评估试剂与对照试剂检测结果一致的样本有233例，检测结果不一致的样本有14例（其中8例阴阳性结果不一致、6例定量结果对数值差异大于1），14例不符样本用复核试剂检测确认后，均与被评估试剂检测结果一致。以复核试剂检测结果最终判断：被评估试剂的一致率为100．00％。对177例被评估试剂与对照试剂定量线性范围内样本进行统计分析，定量相关性为0．9671。结论被评估试剂与已上市的国内同类产品在检测功能上具有等效性，被评估试剂灵敏度、定量准确性与Roche检测结果一致性相近，高于对照试剂。

Evaluation of a new domestic nucleic acid quantitative detection kit for human immunodeficiency virus type 1

Objective To evaluate the variation and stability of a new domestic nucleic acid quantitative detec-tion kit for human immunodeficiency virus type 1（ HIV-1） .Methods A total of 247 blood samples were detected by both the tested kit and the contrast kit approved by SFDA ,when different results were obtained ,the sample was re-examined with HIV-1 vrral load kit producted by Roche company .Results The results of 233 samples from the test-ed kit and the control kit were consistant ,and 14 samples were not consistent（8 samples were proved to be positive by the tested kit but to be negative by the control kit .Another 6 samples showed that the difference of the lg values between the two kits were more than 1） .The results weren＇t consistent reexamined by the revcew kit were in consis-tency with the results from the tested kit .The consistency of the evaluated kit with the control kit and the reexamined ki was 100% .There was a strong overall correlation of the test results between the two methods （r=0 .976 1） .Con-clusion High qualitative consistency and strong correlation between the tested kit and the control kit were found , and the tested kit showed the same sensitivity ,accuracy and consistency with the reexamined kit .