六西格玛理论在4种胱抑素C试剂性能评价中的应用  

The application of the Six Sigma theory in the performance evaluation of the four cystatin C reagents

作　　者：袁勇[1] 孔凡斌[1] 吴晓明 李铮[1] 陈琪 吉永 高辉[1] 

机构地区：[1]昆明医科大学附属延安医院检验科,云南昆明650051

出　　处：《国际检验医学杂志》2018年第5期591-594,共4页International Journal of Laboratory Medicine

摘　　要：目的测定4种胱抑素C(CysC)试剂的精密度和准确度,并根据六西格玛(σ)参数为新开展项目初步选择合适的检测系统,再对选出的试剂进行全面评价。方法用患者新鲜混合血清评价4种CysC试剂(A、B、C、D)的不精密度(CV%),通过测定2016年卫计委室间质评CysC项目的5个标本来评价各试剂盒的偏倚(Bias%),通过卫计委室间质评规定的总允许误差(TEa)计算西格玛值和质量目标指数(QGI),绘制西格玛验证图,对结果进行比较分析。再对西格玛值最高的试剂盒进行线性范围验证、干扰实验、临床可报告范围验证和生物参考区间的验证。结果 4种CysC试剂(A、B、C、D)的不精密度分别是6.11%、5.39%、3.13%、3.66%,偏倚分别是4.63%、4.42%、5.38%、1.09%,西格玛水平分别是4.15σ、4.75σ、7.87σ、7.90σ,A、B试剂盒的QGI分别是0.50、0.55。西格玛验证图得出A、B试剂性能为良好水平,C、D试剂性能为世界一流水平。4种试剂中,D试剂的总体性能最好。再对D试剂进行线性范围验证、干扰实验、临床可报告范围验证和生物参考区间的验证,结果均符合说明书的申明及临床的需求。结论西格玛性能验证能直观地反映出不同试剂之间的性能差异,能用于试剂盒的初步筛选。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,7.87σand 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.

关 键 词：胱抑素C 六西格玛 质量目标指数 精密度 偏倚 

分 类 号：R-331[医药卫生] R446.1