6σ质量管理理论在电化学发光法测定肿瘤标志物中的应用

The application of 6σ theory for quality management in the detction of tumor markers using electrochemiluminescence system

目的探讨六西格玛(6σ)质量管理理论在电化学发光测定肿瘤标志物中的应用。方法根据Westgard等报道的方法计算σ值,分别选用以生物学变异确定的"合适"及"理想"允许总误差(TEa)为质量目标,不精密度(CV%)源于为该室室内质控累积CV%,不准确度(Bias%)源于卫生部临床检验中心肿瘤标志物室间质评结果。结果不同质量目标有不同的σ值及不同的质控方案。结论合理地采用质量目标,结合6σ质量管理理论指导质量控制方案的设计,适合于临床检验质量管理。

Objective To investigate the application of 6σ theory for quality management in the determination of tumor markers using electrochemiluminescence system.Methods σvalue was calculated by Westgard method,and the suitable and ideal TEa（allowable total error）were selected as the quality target based on the biological variation,and the imprecision derived from the internal quality control CV accumulated in our laboratory,and the inaccuracy derived from the results of tumor marker of external quality assessment in clinical laboratory center of ministry of health.Results The different quality target would possess the different σvalue and quality control procedure.Conclusion It is compatible for clinical laboratory to use the quality target reasonably and design the quality control procedure based on 6σ theory.