攀枝花市五家医学实验室尿素和肌酐检测结果的比对研究

目的 探讨实验室间不同生化检测系统结果的可比性,为推动实验室间检验结果的互认提供参考。方法 五家实验室检测病人新鲜血清,连续20次分别测定Urea和Cr等10个生化项目,进行精密度分析; 参照美国临床和实验室标准协会(CLSI )EP9-A2文件,以攀钢集团总医院生化检测系统作为比较系统,其余四家医院生化检测系统作为待评系统,检测病人新鲜血清,均分别检测五个生化组合项目(Urea,Cr),(AST,ALT),(TP,ALB),(TG,TC)和(HDL-C,LDL-C),每个组合项目连续测定5天,测定结果进行比对分析,计算比较系统和待评系统之间的相关系数、直线回归方程和不同医学决定水平处的相对偏倚(SE%),并以美国临床实验室改进修正案能力验证(CLIA'88)允许总误差(TEa)的1/2为标准,判断待评系统与比较系统之间的可比性和临床可接受性。结果 以Urea和Cr测定为例,五家实验室间Urea和Cr两项目的CV值均小于CLIA'88允许总误差的1/3,精密度均符合要求。检测结果显著相关(r²＞0.975); 临床可接受性能评价中,在Urea低医学决定水平处,有两家实验室的测定结果为临床不可接受; 在Urea高医学决定水平处,有一家实验室的测定结果为临床不可接受; 在Cr低医学决定水平处,有两家实验室的测定结果为临床不可接受; 其余待评系统Urea和Cr项目在各医学决定水平与比较系统比较,其SE%均小于CLIA'88允许总误差的1/2,为临床可接受。结论 实验室间不同生化检测系统的测定结果存在不同程度的偏倚,部分项目偏倚超出允许误差范围。

Comparative Study of Detection Results of Urea Nitrogen and Creatinine for Five Medical Laboratory

Objective To investigate the different biochemical testing system inter laboratory comparability of results,provide referencefor promoting inter laboratory test results of the recognition.Methods Five patients with laboratory detection of fresh mixed serum,20 consecutive determination of 10 biochemical items,precision analysis.According to America clinical and Laboratory Standards Institute(CLSI)Document EP9-A2,the Panzhihua Iron and Steel Group General Hospital detection system as the reference system,the remaining four hospital detection system as the detection system,with a fresh mixed serum,determination of five biochemical items(Urea,Cr),(AST,ALT),(TP,ALB),(TG,TC)and(HDL-C,LDL-C),the determination results were compared and analyzed,calculated reference system and the correlationcoefficient,linear regression equation between the system and the various medical decision level relative deviation(SE%),and to America Clinical LaboratoryImprovement Amendment ability test(CLIA'88)allowed total error of 1/2 as thestandard,to the assessment system and the reference system between the comparability and clinical acceptability.Results In Urea,Cr determination for example,CV of five laboratories on Urea and Cr two project was less than CLIA'88 allowed total error of 1/3,the precision could meet the clinical requirements.The detection results significantly correlated(r²＞0.975).The evaluation of clinical acceptability,in Urea low at medical decision level,there were two laboratory determination results that could not be accepted for clinical.In Urea high at medical decision level,there was a laboratorymeasurement result that could not be accepted for clinical.In the low Cr at medical decision level,there were two laboratory determination results that couldnot be accepted for clinical.The rest of the system Urea,Cr projects in various medical decision level compared with the system,the SE% was less than CLIA'88 allowed total error of 1/2,for clinical acceptable.ConclusionLaboratory determination results between different biochemical testing system had bias in different degrees,bias part of the project exceeds the allowed error range.