常州地区血液核酸检测无效结果分析

Analysis of invalid results of blood nucleic acid detection in Changzhou Area

目的:统计分析常州地区血液核酸检测无效情况,查找引起检测无效的原因并提出应对策略,为提高血液核酸检测质量提供依据。方法:运用罗氏全自动核酸检测系统对2017年无偿献血者血液标本进行核酸检测,并对检测无效结果运用GraphPad Prism 5.0软件进行χ~2检验,找出无效原因并提出相应解决措施。结果:2017年度血液检测样本41 939例,混检共7 140 pool(6份检测标本为1个pool),无效率为0.24%(共17 pool,102例检测标本);总Batch数574架次(120个检测标本为1个Batch),无效率1.4%(共8 Batch,960例检测标本)。仪器问题、软件问题、标本问题、质控品检测无效、操作过程不规范均是引起无效结果的原因。结论:加强核酸检测过程前、中、后的控制,尤其是质控品的保存使用及标本质量,才能降低检测无效出现的频率,进一步提高核酸检测结果的及时有效。

Objective:To statistically analyze the invalidation of Roche nucleic acid detection in Changzhou area,and find out the cause of invalid detection and propose countermeasures,providing a basis for improving the quality of nucleic acid detection.Method:After the nucleic acid test of blood samples of unpaid blood donors in 2017,the statistical analysis of the invalid results was carried out to find out the cause of the invalidity and propose corresponding solutions.Result:In this laboratory,41 939 samples were under mixed test in 2017,a total of 7 140 pools,the ineffective rate was 0.24%;the total number of batches was 574,and the inefficiency was 1.4%.Instrument problems,software problems,specimen problems,invalid control of quality items and irregular operation procedures were all causes of invalid resaults.Conclusion:It is essential to strengthen control during the nucleic acid detection process,especially the preservation and use of quality control products and the quality of the specimens,reducing the frequency of detection invalidation,further improve the timely and effective detection results of nucleic acids.