【摘要】 目的对山西省15家三级甲等医院临床化学9个互认项目实施质量评价,建立临床化学检验项目参比检测系统,以保证临床化学互认检测项目的可溯源性与可比性。方法通过15家三级甲等医院2016年-2017年上报与参加国家卫计委临床检验中心室内质控(internal quality control,IQC)与室间质评(external quality assessment,EQA)结果,依据贝克曼(Beckman AU)、罗氏(Roche)、日立(Hitachi)三个检测系统分组,依据美国1988年临床实验室改进法案修正案(Clinical Laboratory Improvement Amendment′88,CLIA′88)允许总误差(TEa)标准进行综合评价,并对室间质评结果进行相关性回归分析。结果经过Microsoft EXCEL软件分析,三个检测系统临床化学互认项目累积室内质控变异系数(CV%)<1/4 TEa,室间质评绝对平均偏倚(Bias%)<1/2 TEa,σ性能多数处于良好水平以上;三个系统两两之间相关系数(r)均≥0.975,斜率(b)均≥0.90。结论三个检测系统室内CV%、室间Bias%、σ性能及相互比对结果均达到标准要求,三个检测系统比对项目室间质评测定结果具有高度一致性,可以作为今后山西省临床化学检验项目结果互认可溯源的参比检测系统。更多还原

【Abstract】 Objective To evaluate the quality of nine mutual recognition projects in clinical chemistry of 15 three grade first class hospitals in Shanxi Province, and to establish a reference test system, in order to ensure the traceability and comparability of clinical chemical mutual recognition testing projects. Methods The results of the laboratory internal quality control(IQC) and external quality assessment(EQA) from 15 three grade first class hospitals in 2016-2017 were enrolled in this study. Three detection systems were grouped according to Beckman, Roche, and Hitachi, considering the Clinical Laboratory Improvement Amendment′88(CLIA′88) allowed the total error(TEa) standard, the correlation regression analysis was carried out on the results of interventricular quality assessment. Results Analysis by Microsoft Excel software showed that the cumulative IQC coefficient(CV%) was < 1/4 TEa, the absolute average bias of the EQA(Bias%) was < 1/2 TEa, and the σ performance was mostly above a good level; the correlation coefficient(r) between the two systems was ≥ 0.975 and the slope(b) was ≥ 0.90. Conclusions The results of the three detection systems including IQC CV%, EQA Bias%, and σ performance all meet the standard requirements. The three detection systems′EQA results are highly consistent, and can be used as traceable reference detection systems for the mutual recognition of clinical chemical test results in Shanxi Province.更多还原