HBV／HCV／HIV血液核酸筛查试剂的性能验证研究

Evaluation on analysis function of a new reagent for nucleic acid testing of HIV/HBV/HCV in blood donors

目的：对罗氏 cobas（R） TaqScreen MPX 2．0试剂在本实验室进行献血者 HIV ／HBV ／HCV 核酸检测的性能进行研究。方法用 HIV ，HBV ，HCV 阳性样本进行稀释后重复检测，对检测结果进行 Probit 分析确定其95％检出限，与试剂说明书分析灵敏度进行比较；用三个阳性样本和三个阴性样本进行六混样模式检测后，进行拆分检测，分析其检测特异性并验证其混样模式；用10个阴性样本和10个阳性样本进行间隔排列后分析该系统是否能有效避免交叉污染，通过同一阳性样本重复检测所得 Ct 值的标准差和变异系数，分析其检测重复性。结果 co‐bas（R） TaqScreen M PX 2．0试剂具有较高的分析灵敏度，其 HIV‐1，HBV 和 HCV 的95％检测下限分别为：28．62IU ／mL（14．03‐72．24）；＜1．15 IU ／mL ；16．78 IU ／mL （7．85‐49．82）；三个阳性样本和三个阴性样本进行六混样模式检测为阳性，进行拆分检测阳性样本的检出率为100％，可有效检测 HIV ，HBV ，HCV 样本；阳性样本为50％的样本组合进行间隔排列检测阴性检出率为100％，无一例交叉污染；HIV ，HCV ，HBV 阳性样本重复检测变异系数很低分别为：0．26，0．25和0．21。结论该试剂在本实验室具有较高的分析灵敏度，较好的特异性和重复性，该检测系统在本实验室使用可以有效防止交叉污染。

Objective To evaluate the analysis function of Roche cobas（R） TaqScreen MPX 2 .0 for nucleic acid testing （NAT ） of HIV/HBV /HCV in our blood screening laboratory .Methods The HIV ,HBV ,HCV positive samples were diluted and tested repeatedly and then analyzed by Probit method to estimate the 95% LOD which was then compared with the 95% LOD reported by the manufacture .Three positive samples and three negative samples were pooled and tested by this reagent and then every sample was tested by the reagent individually ,through which the specificity and the pooling model were analyzed .Ten positive and ten negative samples were placed with a positive samples followed by a negative sample and tested by this reagent ,through which the robustness of the system against cross‐contamination and reproducibility of the reagent were analyzed .Results The analytical sensitivity of cobas（R） TaqScreen M PX 2 .0 is very high with the 95% LOD of HIV‐1 ,HBV and HCV as 28 .62IU /mL （14 .03‐72 .24） ,〈1 .15 IU /mL and 16 .78 IU /mL （7 .85‐49 .82） respectively .The pool of three positive samples and three negative samples was tested as positive and every sample got the right answer in the individual testing .No contamination oc‐curred in the ten positive and ten negative samples testing which indicated that this system has strong robustness a‐gainst cross‐contamination .In the reproducibility analysis ,the CV was 0 .26 ,0 .25 and 0 .21 respectively for HIV , HCV and HBV .Conclusion This reagent has a relatively high analytical sensitivity ,specificity and reproducibility and Roche cobas s201 system has a relatively strong robustness against cross‐contamination .