核酸检测试剂灵敏度改进效果分析

Effect analysis of reagent improvements in nucleic acid testing in Chongqing

目的分析采用盖立复公司全自动核酸检测系统检测新旧两代试剂的检测结果和鉴别频次调整前后的对比的结果,观察核酸集中化检测后的改进效果。方法分析2016年1月—2017年7月重庆市血液中心和各基层血站/库送检的共313 589份酶联免疫吸附测定法（enzyme-linked immunosorbent assay,ELISA） 3项（抗-HBsAg、抗-HCV、抗-HIV）非反应性血液标本的核酸检测（NAT）结果,比较2套试剂的单反应率,鉴别反应率,以及鉴别频次调整后等情况,并进行统计学分析。结果对Procleix Ultrio Assay和Procleix Ultrio Plus Assay 2代试剂进行分析,前者单反应率为3. 49‰,后者为5. 24‰。前者鉴别反应率为29. 17%,后者为38. 0%。鉴别频次经3次调整至每天检测1次,鉴别反应率分别为36. 0%,36. 0%,41. 0%（P〉0. 05） 3者无显著的统计学差异,但中心和基层血站/库鉴别反应率趋于稳定,促进献血者追踪。结论新一代核酸试剂Procleix Ultrio Plus Assay具有更高的灵敏度,能有效降低经血液传播疾病的风险,核酸鉴别频次的增加更有利于对＂窗口期＂献血者的追踪和随访,促进经血传播病毒的研究,进一步保障了全市的血液安全。

Objective Mass-batch nucleic acid testing（ NAT） was performed with two generations of reagents adjusted discrimination frequencies to evaluate their performance. Methods A total of 313589 NAT samples with no enzyme-linked immunosorbent assay（ ELISA）（ anti-HBsAg、anti-HCV、anti-HIV） reactivity from numerous blood centers in the Chongqing region were collected and applied to the evaluation model mentioned prior. Results were analyzed by statistical analyzing tools. Results The two reagents applied were Procleix Ultrio Assay and Procleix Ultrio Plus Assay. The former showed a single reaction rate of 3. 5‰ and the latter showed a single reaction rate of 5. 2‰. As for the discrimination rates,the former was29. 17%,and the latter increased to 38%. Test frequency was adjusted from one time every seven days to one time daily by an interval of 3. The discrimination rates were 36%,36% and 41% respectively with no significant difference between the three groups. Nevertheless,the rate of single positive reaction and identification become more stable. Conclusion the new generation of NAT reagent Procleix Ultrio Plus Assay showed higher sensitivity and specificity,and the increase of identification frequency is beneficial to track the window phase specimens and follow-ups. NAT detection have effectively reduced the risk of blood transfusion,guaranteed the safety of blood transfusion.