“半衰期^(+)”室内质控频率新策略在化学发光免疫检测项目中的应用

Application of a novel strategy of half^(+)-life for internal quality control frequency of chemiluminescence immunoassay tests

目的通过对化学发光免疫检测项目室内质控失控数据进行分析,探讨“半衰期^(+)”室内质控实施频率模式在化学发光免疫检测项目检测中的应用。方法回顾性分析重庆市人民医院检验科2021年1月至2023年12月化学发光免疫检测项目室内质控的失控数据、失控原因及处理措施,建立并评估“半衰期^(+)”室内质控实施频率模式。结果3年内化学发光免疫检测项目失控总次数为326项次,质控品原因(92.33%)为最主要失控原因,但该类原因所致失控不影响临床标本检测结果准确度;试剂原因(3.37%)、校准原因(2.76%)和其他原因(1.53%)导致的失控会影响临床标本检测结果准确度。“半衰期^(+)”室内质控新策略可明显减少室内质控失控频率(0.38%vs.0.16%),且有效识别影响临床标本检测结果准确度的失控。结论在化学发光免疫检测项目中,“半衰期^(+)”的室内质控频率新策略在保证检测系统质量可靠的同时,可大幅降低室内质控频率及“假失控”次数,节约人力、物力成本,提升实验室质量管理水平。

Objective To investigate the application of"half-life^(+)"internal quality control frequency in chemiluminescence immunoassay tests by analyzing the characteristics of out-of-control incidents of chemiluminescence immunoassay testing.Methods A retrospective analysis was performed based on out-of-control data,reasons and measures for internal quality control of chemiluminescence immunoassay tests in Department of Clinical Laboratory of Chongqing General Hospital from January 2021 to December 2023.The pattern of"half-life^(+)"internal quality control frequency was established and evaluated.Results A total of 326 out-of-control incidents were identified in this study,the quality control product reasons(92.33%),which would not influence the accuracy of sample tests,was the main reason of out-of-control incident;the out-of-control incident by reagent reasons(3.37%),calibrator reasons(2.76%)and other reasons(1.53%)would influence the accuracy of sample tests."Half-life^(+)",a novel strategy,would apparently decrease the frequency of out-of-control incident in internal quality control(0.38%vs.0.16%),and it would influence the accuracy of sample tests.Conclusion In the test of chemiluminescence,the novel"half-life^(+)"strategy of internal quality control can make sure a reliable tests system,while it also can decrease the frequency of internal quality control and"false out-of-control incident",saving cost of manpower and material resources and improving management of laboratory quality.