血液核酸筛查系统结果无效类型及原因分析  

Analysis of the types and causes of invalid results in nucleic acid test for blood screening

作　　者：杜荣松[1] 王淏[1] 李仲平[1] 梁浩坚[1] 谢君谋[1] 郑优荣[1] DU Rongsong;WANG Hao;LI Zhongping;LIANG Haojian;XIE Junmou;ZHENG Yourong(Guangzhou Blood Center,Guangzhou 510095,China)

机构地区：[1]广州血液中心、广州市医学重点实验室血液安全实验室,广东广州510095

出　　处：《中国输血杂志》2023年第1期53-56,共4页Chinese Journal of Blood Transfusion

基　　金：广州市科技计划项目(202002030192);广州市医学重点学科建设项目(血液安全实验室)。

摘　　要：目的 通过分析血液核酸检测结果无效的原因,探讨降低检测无效的对策。方法 统计2019~2021年本实验室Cobas s201血液核酸筛查的检测数量及无效结果的批次、测试数量,分析无效结果的类型和原因。结果 2019~2021年本实验室Cobas s201核酸检测系统共检测5 420批次和127 950测试量,批次无效率和测试无效率分别为1.83%和1.97%。结果无效可分为操作不当、标本质量问题、质控无效、设备故障和其它5种类型,其中质控无效和设备故障导致的结果无效比例最高,分别占全部测试无效的44.51%和39.96%。质控无效主要与标本交叉污染和质控品混匀不充分有关,设备故障多发生于核酸提取仪的机械臂抓手和扩增仪的TC模块。结论 实验室应对结果无效进行质量监测,采取针对性改进措施,特别应减少质控无效和仪器故障导致的结果无效。Objective To analyze the reasons for the invalidity of blood nucleic acid test results, and to explore the countermeasures to reduce the invalidity of the test. Methods From 2019 to 2021, the number of tests performed in our laboratory for Cobas s201 blood nucleic acid screening system and the number of batches and tests with invalid results were counted, and the types and reasons of invalid results were analyzed. Results From 2019 to 2021, the Cobas s201 nucleic acid detection system detected a total of 5,420 batches and 127,950 pools, and the invalid rate of batches and pools were 1.83% and 1.97%, respectively. The types of invalid results can be summarized as improper operation, sample quality problems, invalid quality control(IQC), equipment failure and others. Among them, IQC and equipment failure were the main reasons for invalid results, accounting for 44.51% and 39.96%, respectively. IQC was mainly related to cross-contamination of samples and insufficient mixing of quality control products. Equipment failures mostly occurred in the robotic arm gripper of the nucleic acid extraction instrument and the TC module of the amplification instrument. Conclusion The laboratory should conduct quality monitoring for invalid results, and take targeted improvement measures, especially to reduce invalid results caused by invalid quality control and instrument failure.

关 键 词：血站 核酸检测 结果无效 质量监测 

分 类 号：R457.1[医药卫生—治疗学] R446[医药卫生—临床医学]