血站核酸实验室质量监测指标及无效结果分析

Analysis of quality monitoring indicators and invalid results of nucleic acid laboratory in blood station

目的对渭南市中心血站核酸实验室质量监测指标及无效结果产生的原因进行分析,为核酸实验室的科学化管理及质量管理体系的有效运行提供理论依据。方法回顾性分析渭南地区2017-2019年无偿献血人群核酸检测的检测例数、不合格率、混样反应性率、拆分反应性率、无效批次率、防污染监测结果、室间质评等质量监测指标,并对无效结果进行原因分析。结果2017-2019年检测例数逐年增加,不同年份间不合格率、混样反应性率、拆分反应性率、无效批次率等质量监测指标比较,差异无统计学意义(P>0.05)。CAP故障是2017、2018年核酸检测结果无效的主要原因,丙型肝炎病毒RNA曲线未起和CAP故障是2019年核酸检测结果无效的两大主要原因,2019年无效pools数最多,占总无效pools数的62.12%(P<0.05)。2017-2019年608个防污染监测点位样本,出现1例乙型肝炎病毒DNA阳性,100例室间质评标本检测总符合率为99.00%。结论该血站核酸实验室目前所使用的质量监测指标能有效反映核酸检测过程,有助于质量管理体系的有效运行和持续改进;但因设备故障导致的结果无效仍是目前核酸实验室面临的最大问题。

Objective To analyze the quality monitoring indicators and the causes of invalid results of the nucleic acid laboratory in Weinan Blood Station,and provide a theoretical basis for the scientific management of the nucleic acid laboratory and the effective operation of the quality management system.Methods Retrospective analysis on quality monitoring indicators for nucleic acid test of blood donation in Weinan area from 2017 to 2019,including the number of test persons,unqualified rate,mixed test positive rate,split test positive rate,invalid batch rate,anti-pollution monitoring results,external quality assessment,etc,and analyze the causes of invalid results.Results From 2017 to 2019,the number of test subjects increased year by year,and there were no statistically significant differences in quality indicators such as unqualified rate,mixed test positive rate,split test positive rate,invalid batch rate(P>0.05).CAP failure is the main reason for invalid nucleic acid test results in 2017 and 2018 while HCV RNA failure and CAP failure are the two main reasons for invalid nucleic acid test results in 2019,invalid pools of 2019 were the largest,accounting for 62.12% of the total invalid pools(P<0.05).From 2017 to 2019,samples from 608 anti-pollution monitoring sites showed HBV DNA positive in 1 case,and the total compliance rate of 100 external quality assessment samples was 99.00%.Conclusion The quality monitoring indicators currently used in nucleic acid laboratory can effectively reflect the nucleic acid detection process and contribute to the effective operation and continuous improvement of the quality management system.However,invalid results due to equipment failures are still the biggest problems facing nucleic acid laboratories at present.