The Application of Top-down Method in Evaluating Biochemical Measurement Uncertainty
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 FT3,T3,FT4,T4,TSH,COR,FA,VitB12,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.
Top-down methodMeasurement uncertaintyIndoor quality control (IQC)External quality assessment (EQA)
万方数据
维普
