CAJ | 학술논문

目的：应用六西格玛（6σ）质量管理方法对Roche Cobas E601电化学发光免疫分析系统检测项目的性能进行量化，并设计各项目的质量控制方案，指导质量持续改进。方法根据σ＝[允许总误差（TEa）－偏倚（Bias）]/变异系数（CV），计算14个检测项目的σ水平，评价各项目的分析性能。其中TEa以卫生部临床检验中心（NCCL）室间质量评价的评价标准，Bias以本室参加NCCL室间质量评价的平均偏倚计算所得，本室室内质量控制日间不精密度（CV%）反映不精密度。根据Westgard等对σ值的说明，制定个体化的室内质量控制方案；同时计算各项目的质量目标指数（QGI），对于性能未达到6σ的项目，查找导致性能不佳的主要原因，并确立性能改进的方案。结果14个检测项目的总性能σ水平为3.80～9.19，平均σ＝6.20，σ≥6、5、4、3的分别占42.9％、21.4％、28.6％、7.1％；分析性能未达到6σ的项目中，75％需要优先改进精密度。结论6σ质量标准能对电化学发光免疫分析系统的性能作出全面的评价，对设计个体化的质量控制方案和指导质量持续改进具有重要意义。
목적：응용륙서격마（6σ）질량관리방법대Roche Cobas E601전화학발광면역분석계통검측항목적성능진행양화，병설계각항목적질량공제방안，지도질량지속개진。방법근거σ＝[윤허총오차（TEa）－편의（Bias）]/변이계수（CV），계산14개검측항목적σ수평，평개각항목적분석성능。기중TEa이위생부림상검험중심（NCCL）실간질량평개적평개표준，Bias이본실삼가NCCL실간질량평개적평균편의계산소득，본실실내질량공제일간불정밀도（CV%）반영불정밀도。근거Westgard등대σ치적설명，제정개체화적실내질량공제방안；동시계산각항목적질량목표지수（QGI），대우성능미체도6σ적항목，사조도치성능불가적주요원인，병학립성능개진적방안。결과14개검측항목적총성능σ수평위3.80～9.19，평균σ＝6.20，σ≥6、5、4、3적분별점42.9％、21.4％、28.6％、7.1％；분석성능미체도6σ적항목중，75％수요우선개진정밀도。결론6σ질량표준능대전화학발광면역분석계통적성능작출전면적평개，대설계개체화적질량공제방안화지도질량지속개진구유중요의의。
Objective Application of 6 sigma(6σ) quality standard to quality of Roche Cobas E601 electroche-miluminescence (ECL) test item analysis performance, and design the appropriate quality control strategy to improve quality control. Methods The sigma value of 14 items were calculated according the equation σ=(TEa-Bias)/coefficient of variation (CV) to reflect the performance of analytic phase. Define the analytical quality requirement for the test in the form of a total allowable error (TEa) by reference NCCL proficiency testing criteria and determine the imprecision and inaccuracy of each item. The quality control strategy was designed accordingly. Quality goal index(QGI) was calculated to find the cause of any error for the items which was below 6σ and improved the strategy. Results The value of σ was between 3.80-9.19 and average was 6.20, 42.9%, 21.4%, 28.6% and 7.1% of all 14 items were over 6, 5, 4 and 3 sigma metrics respectively with the averaged. The accuracy of 75% items required improved which value was below 6σ. Conclusion Six σ quality standard could comprehensively evaluated ECL test item analysis performance , it is of great significance to design individualized quality control plan and quality improvement.