The application of the Six Sigma theory in the performance evaluation of the four cystatin C reagents / 国际检验医学杂志

ABSTRACT

Objective To determine the accuracy and accuracy of 4 cystatin C (CysC) reagents,to initially select a suitable detection system according to the Six Sigma parameters for the new development projects,and to evaluate the selected reagents comprehensively.Methods Imprecision (CV％) of 4 kinds of CysC reagents (A,B,C,D) were evaluated with mixed fresh serum of patients,the bias of each kit (Bias％) was evaluated by measuring 5 specimens of the CysC project 2016 Health Planning Commission interventricular quality assessment,the total allowable error (TEa) from Health Planning Commission interventricular quality assessment was used to calculate the Sigma value and quality target index (QGI),sigma verification diagram was rendered,and the results were compared.The linear range verification,interference experiment,clinical reporting range verification and biological reference interval validation were carried out for the highest sigma kit.Results The CV value of four kinds of CysC reagents(A,B,C,D)were 6.11％,5.39％,3.13％ and 3.66％.The value of bias were 4.63％,4.42％,5.38％ and 1.09％.The sigma value were 4.15σ,4.75σ,7.87σ and 7.90σ.The quality target index(QGI) of A and B were 0.50 and 0.55,The sigma performance verification diagrams indicated that the reagent A and B were at good performance level and reagent C and D were at the world class level,D was the best one.The linear range validation,interference test,clinical reportable range validation and biological reference interval validation of D reagent were carried out,which all accorded with the declaration and clinical needs of the instructions.Conclusion The performance verification of Sigma can directly reflect the difference of performance between different reagents,and can be used for the preliminary screening of the kit.