六西格玛在肿瘤标志物质量目标选择上的应用

目的应用6σ理论对肿瘤标志物项目的分析性能进行评价,并初步确定各项目的质量目标。 方法收集本实验室2018年1至12月室内质控数据和国家卫生健康委临床检验中心室间质量评价结果,以生物学变异导出的质量规范和国家室间质量评价标准作为允许总误差(TEa)计算6项肿瘤标志物的σ水平,并依据质量目标选择流程图和肿瘤标志物分析性能验证图评价肿瘤标志物的分析性能,进而为肿瘤标志物选择合适的质量目标。 结果应用不同层级的生物学变异导出的质量规范和国家室间质量评价标准,肿瘤标志物项目的σ水平存在显著差异;依据质量目标选择流程图：选择生物学变异导出的"适当的"质量规范作为CA125项目的质量目标,选择生物学变异导出的"最低的"质量规范作为t-PSA、CEA、AFP、CA199和CA153项目的质量目标。 结论6σ能够客观评价肿瘤标志物的分析性能,并为实验室质量目标的选择提供重要的参考价值。

Application of Six Sigma in the selection of quality objectives of tumor markers

ObjectiveSix Sigma theory was applied to evaluate the analytical performance of tumor markers, and the quality objectives of each project were preliminarily determined. MethodsThe internal quality control (IQC) data and external quality assessment (EQA) of National Center for Clinical Laboratories in our laboratory from January to December 2018 were collected, and the quality specification derived from biological variation and the standard of EQA were used as allowable total error (TEa) to calculate Sigma levels of six tumor markers. According to the flow chart of quality goal selection and the validation chart for analytical performance of tumor markers, the analytical performance of each project were evaluated, and then the appropriate quality objectives of tumor markers were determined. ResultsThere were significant differences among sigma levels of tumor markers by applying the quality specification derived from different levels of biological variation and the standard of EQA. According to the quality objectives, choose flow chart "appropriate" quality criteria derived from biological variation as CA125 quality objectives, and "minimal" quality criteria derived from biological variation as t-PSA, CEA, AFP, CA199 and CA153 quality objectives. ConclusionSix Sigma can objectively evaluate the analytical performance of tumor markers and provide an important guidance for the selection of laboratory quality objectives.