流水线自动质控在临床生化免疫检验中的评估与应用  

Evaluation and application of automated quality control of automatic pipeline in clinical biochemical and immunological detection

作　　者：侯立安[1] 尚雪松[1] 马超超 夏良裕[1] 刘荔[1] 张颖[1] 苏玉君[1] 刘欣[1] 邱玲[1] Hou Li′an;Shang Xuesong;Ma Chaochao;Xia Liangyu;Liu Li;Zhang Ying;Su Yujun;Liu Xin;Qiu Ling(Department of Laboratory Medicine,Peking Union Medical College Hospital,Beijing 100005,China)

机构地区：[1]中国医学科学院北京协和医院检验科,北京100005

出　　处：《中华检验医学杂志》2024年第1期86-93,共8页Chinese Journal of Laboratory Medicine

基　　金：北京市临床重点专科医学检验科卓越项目(ZK201000);首都卫生发展科研专项(2020-1-4014)。

摘　　要：目的评估全自动流水线自动检测室内质控(自动质控)的适用性。方法利用自动质控实施方法评估北京协和医院检验科于2019年1月至2022年7月18个生化项目、5个免疫比浊项目、11个化学发光项目的自动质控稳定性、检测效率和实施成本。具体方法:将生化、免疫比浊以及化学发光项目的质控品存储在流水线冰箱中,由中间体软件控制流水线,按设置时间自动调取质控品上机测定并归档保存。生化项目的质控设置为每日和每周更换质控品2种模式,共同运行3个月,通过比较2种模式质控结果的变异系数(CV)评估质控品在线存储稳定性。分析自动质控和手动质控结果变异、质控失控率、质控品消耗量、员工工作量、首个样本检测时间和自动质控故障率6个指标,评估自动质控应用效果。结果(1)质控品在线存储稳定性:每周更换生化在线质控品模式下,总二氧化碳(TCO_(2))高低两水平质控的CV分别为20.24%和21.82%,大于实验室设定的允许变异;丙氨酸转氨酶(ALT)等其他16个项目变异均小于允许变异。(2)自动和手动质控模式下质控结果变异:每日更换生化在线质控品、每周更换免疫比浊和化学发光在线质控品的模式下,硫酸脱氢表雄酮、雌二醇、卵泡刺激素、促黄体生成素、铁蛋白、叶酸、维生素B12和睾酮8个化学发光项目,补体3、C反应蛋白和免疫球蛋白G 3个免疫比浊项目和碱性磷酸酶、葡萄糖、钙、氯、钾、乳酸脱氢酶、钠、尿素、低密度脂蛋白胆固醇和腺苷脱氨酶10个生化项目的低、高水平质控自动质控检测结果的CV均低于手动质控结果的CV。2种质控模式的生化、免疫比浊和化学发光项目的失控率均符合临床常规工作需求。(3)质控品消耗量比较:自动质控与手动质控比较,化学发光质控品每周使用量减少37.5%(由8 ml减至5 ml);免疫比浊质控品每周使用量减少33.3%(由3 ml减至2Objective To assess the applicability of fully automatic pipeline automated testing for internal quality control(automated quality control).Methods Stability,assay efficiency and implementation costs of 18 biochemical tests,5 immunoturbidimetric tests and 11 chemical illuminescent tests in the Department of Laboratory Medicine of Peking Union Hospital from January 2019 to July 2022 were evaluated using automated quality control implementation methods.The detailed method is as follows:quality control materials for biochemical,immunoturbidimetric and chemiluminescent tests were stored in the refrigerator in the pipeline which was controlled by the intermediate software,and were automatically retrieved and tested as pre-set followed by documenting and storing.The quality control setup for the biochemical tests included refreshing quality control materials daily and weekly,both of which were paralleled for 3 months.The on-line storage stability of quality control materials in the pipeline was evaluated by comparing the coefficients of variation(CV)of the quality control results between the two patterns.Effect of automated quality control application was evaluated using 6 indicators,including the results′variation of automatically performed and manually performed quality controls,the out-of-controlled rate,the consumption of quality control materials,the change of staff workload,the impact on the testing time of the first sample,and the failure rate of automated quality control.Results(1)Storage stability of quality control materials in the pipeline:under the pattern of weekly refresh of the biochemical quality control materials,except for total carbon dioxide(TCO_(2))(the CVs of low and high level quality control were respectively 20.24%and 21.82%)and sodium(the CV of low level quality control was 1.51%)that were greater than the allowable variation set by the laboratory,the CVs of the rest tests meet the lab requirements on the allowable variations.(2)The results′variation of quality control in automatically per

关 键 词：质量控制 稳定性 变异系数 允许变异 

分 类 号：R446.6[医药卫生—诊断学]