自上而下法在评定生化测量不确定度中的应用

The Application of Top-down Method in Evaluating Biochemical Measurement Uncertainty

目的探讨自上而下法评估测量不确定度在临床生化检验中的应用。方法收集广东省人民医院检验科生化室2019年质控批号稳定至少3个月的室内质控(IQC)数据和国家卫生健康委临床检验中心2017~2019年的室间质评(EQA)回报结果,采用自上而下法评定15项临床生化指标的测量不确定度。结果采用Beckman DXI800化学发光仪检测游离三碘甲状腺原氨酸(FT_(3))、三碘甲状腺原氨酸(T_(3))、游离甲状腺素(FT_(4))、甲状腺素(T_(4))、促甲状腺激素(TSH)、皮质醇(COR)、叶酸(FA)、维生素B_(12)(VitB_(12))、前列腺特异性抗原(PSA)、癌胚抗原(CEA)、甲胎蛋白(AFP)、铁蛋白(FER)、人绒毛膜促性腺激素(β-HCG)、游离前列腺特异性抗原(fPSA)、肌钙蛋白-I(cTnI)15项生化指标的相对扩展标准不确定度,均满足国家卫生健康委临床检验中心室间质量评价标准的要求。其中批间不精密度与相对扩展标准不确定度呈中度相关(r=0.685,P<0.001),偏移呈强相关(r=0.827,P<0.001)。批间不精密度分量占比更大,在大部分生化指标中呈主要分量趋势。结论应用自上而下法评定测量不确定度适用于临床生化检验项目,是一种经济可行的评定方法。不同项目不同分量来源的主要占比不同,为实验室质量管理提供了改进方向。

Objective To estimate the application performance of top-down method to evaluate measurement uncertainty in clinical biochemical tests.Methods We collected indoor quality control(IQC)data of clinical biochemical laboratory of Guangdong Provincial People’s Hospital in 2019,whose batch number was stable for at least 3 months,as well as the external quality assessment(EQA)data of Clinical Laboratory Center of National Health Commission from 2017 to 2019.The top-down method was used to assess measurement uncertainty of 15 clinical biochemical indicators.Results All relative expanded standard uncertainty of FT_(3),T_(3),FT_(4),T_(4),TSH,COR,FA,VitB_(12),PSA,CEA,AFP,FER,β-HCG,fPSA and cTnI(Beckman DXI800)met with the requirements of the Clinical Laboratory Center of the National Health Commission.The relative extended standard uncertainty had a moderate correlation with inter batch imprecision component(r=0.685,P<0.001),and a strong correlation with offset component(r=0.827,P<0.001).The proportion of inter batch imprecision component was larger,and it was the major component in most biochemical indicators.Conclusion The top-down method to evaluate the measurement uncertainty is suitable for clinical biochemical tests,and it is a cost-effective and feasible evaluation method.Moreover,the main proportion of different components in different indicators can provide a direction for the improvement of laboratory quality management.