Roche Cobas 501生化分析仪血清肌酐分析测量范围的验证

目的通过对血清肌酐分析测量范围(AMR)的验证,探讨临床实验室如何按照国际标准要求进行生化分析仪定量检测项目分析测量范围的验证,保证检验结果准确、可靠。方法采用酶法在Roche Cobas 501生化分析仪上检测7个浓度水平美国病理学家协会(CAP)线性范围能力测试样品,这7个样品靶值涵盖厂家说明书标示肌酐分析测量范围低、中、高值,每个样品检测两次取其均值,计算其与靶值的偏倚。另外参照美国临床和实验室标准协会(CLSI)指南文件EP6-P的要求,收集含高值肌酐的新鲜患者血清,按一定比例混合、离心,计算混合物的浓度并将之作为高值样品(H),与经同样处理获得的低值样品(L)分别按5L、4L+1H、3L+2H、2L+3H、1L+4H、5H的关系配制,形成系列样品,在Roche Cobas 501生化分析仪上对各样品的肌酐进行检测,每个样品检测4次,数据进行回归分析。结果 7个水平的CAP样品与靶值的偏倚均小于北京善方医院检验科设定的允许误差±7.5%[(1/2×TE)%]。新鲜患者混合血清样品回归方程为Y=0.988 6 X+16.614,b=0.988 6,介于0.97~1.03,截距a与0经t检验,t_at_(0.05),P0.05,说明截距与0无明显差异,回归直线事实上通过0点。结论厂家说明书标示的血清肌酐分析测量范围验证通过,实验室可以采用。

Verification of analytical measurement range of serum creatinine detected by Roche Cobas 501 Biochemistry Analyzer

Objective To investigate how the clinical laboratory conducting the verification of analytical measurement range (AM R) of quantitative items detected by the biochemical analyzer according to the requirements of the international standards by verifying the serum creatinine AMR for ensuring the accuracy and reliability of detection results .Methods The enzyme method was adopted to detect the 7‐concentration levels test specimens of CAP linear range proficiency test on the Roche Cobas 501 biochemical analyzer .These 7 specimens target values covered the low ,middle and high values of creatinine AMR marked by the manufacturer′s instructions .Each specimen was detected twice and the mean value was taken ,then the bias between the mean value and target value was calculated .In addition ,referring to the requirements of CLSI guiding document EP6‐P ,the patients′fresh serum contai‐ning high value creatinine was collected ,then mixed with certain proportion and centrifuged .The mixture concentration was calcu‐lated and served as the high value specimen(H) ,and the low value specimen was obtained by the same treatment .Then the high and low value specimens were dispensed with the relations of 5L ,4L+1H ,3L+2H ,2L+3H ,1L+4H and 5H and formed the series specimens .The creatinine levels in each specimen was detected on the Roche Cobas 501 biochemical analyzer ,each specimen was de‐tected 4 times .The obtained data were performed the regression analysis .Results The bias of 7‐level CAP specimen and target val‐ue was less than the allowable error ± 7 .5% [(1/2 × TE)% ] set by the clinical laboratory of the Beijing Sanfine Hopsital .The re‐gression equation of fresh mixed serums from patients was Y =0 .988 6X+16 .614 ,b=0 .988 6 ,between 0 .97 -1 .03 ,intercept a and 0 ,ta < t0 .05 ,P>0 .05 ,which showed no significant difference between intercept and 0 ,the regression line was through 0 point in fact .Conclusion The verification of creatinine AMR marked by the manufacturer′s instructions is passed ,which can be adopted by the clinical laboratory .