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（TCO2）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2 ml）。（4）员工工作量和首个样本进样时间比较：自动质控与手动质控比较，员工每周减少手工操作步骤约156步，每日首个样本检测时间平均提前15 min。自动质控开始运行的前期故障率为54.5%（37/64），后期降至10.2%（13/128）。 结论 通过流水线系统自动检测室内质控结果满足实验室质量指标要求，应用自动质控可提高质控水平，节约成本，减轻工作量、提高工作效率。 Objective 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 (TCO2) (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 performed and manually performed control patterns: in the patterns of daily refresh of biochemical quality control materials and weekly refresh of immunoturbidimetric and chemiluminescent quality control materials, the CVs of both low and high levels of quality control were lower in the automatically performed control pattern than that in manually performed pattern for 8 chemiluminescent items of dehydroepiandrosterone sulfate, estradiol, follicle stimulating hormone, luteinizing hormone, serum ferritin, serum folic acid, vitamin B12 and testosterone, 3 immunologic items of complement 3, C reactive protein and immunoglobulin G, and 10 biochemical items of alkaline phosphatase, glucose, calcium, chloride, potassium, lactate dehydrogenase, sodium, urea, low density lipoprotein cholesterol, and adenosine deaminase. The out-of-control rates of biochemistry, immunoturbidimetric and chemiluminescence tests in both quality control patterns conformed with the clinical routine work requirements. (3) Comparison of quality control materials′ consumption: compared with manually performed quality control, weekly consumption of automatically performed chemiluminescent quality control materials decreased 37.5% (from 8 ml to 5 ml) weekly consumption of automatically performed immunoturbidimetric quality control materials decreased 33.3% (from 3 ml to 2 ml). (4)Comparison of staff workload and first sample testing time: compared with manually performed quality control, automatical quality control reduced manual work by about 156 steps per week, and the daily initial testing time was earlier by 15 min on average. The failure rate was 54.5% (37/64) during the early-stage application of the automated quality control which dropped to 10.2% (13/128) in the late-stage. Conclusion The results of automated quality control detected in the pipeline system meet the quality indicators′ requirements of the laboratory, and the application of automated quality control can improve the quality control, save costs, reduce workload, and improve work efficiency.
Evaluation and application of automated quality control of automatic pipeline in clinical biochemical and immunological detection
Objective 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 (TCO2) (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 performed and manually performed control patterns: in the patterns of daily refresh of biochemical quality control materials and weekly refresh of immunoturbidimetric and chemiluminescent quality control materials, the CVs of both low and high levels of quality control were lower in the automatically performed control pattern than that in manually performed pattern for 8 chemiluminescent items of dehydroepiandrosterone sulfate, estradiol, follicle stimulating hormone, luteinizing hormone, serum ferritin, serum folic acid, vitamin B12 and testosterone, 3 immunologic items of complement 3, C reactive protein and immunoglobulin G, and 10 biochemical items of alkaline phosphatase, glucose, calcium, chloride, potassium, lactate dehydrogenase, sodium, urea, low density lipoprotein cholesterol, and adenosine deaminase. The out-of-control rates of biochemistry, immunoturbidimetric and chemiluminescence tests in both quality control patterns conformed with the clinical routine work requirements. (3) Comparison of quality control materials′ consumption: compared with manually performed quality control, weekly consumption of automatically performed chemiluminescent quality control materials decreased 37.5% (from 8 ml to 5 ml) weekly consumption of automatically performed immunoturbidimetric quality control materials decreased 33.3% (from 3 ml to 2 ml). (4)Comparison of staff workload and first sample testing time: compared with manually performed quality control, automatical quality control reduced manual work by about 156 steps per week, and the daily initial testing time was earlier by 15 min on average. The failure rate was 54.5% (37/64) during the early-stage application of the automated quality control which dropped to 10.2% (13/128) in the late-stage. Conclusion The results of automated quality control detected in the pipeline system meet the quality indicators′ requirements of the laboratory, and the application of automated quality control can improve the quality control, save costs, reduce workload, and improve work efficiency.
Quality controlStabilityCoefficient of variationAllowable variation
万方数据
