上海市23项临床化学检验项目的允许误差范围

Study the allowable total error range for 23 analytes of clinical chemistry in Shanghai

目的 调查分析上海市二、三级医院, 23项临床化学检验在常规条件下的变异系数(RCV)现状。探讨今后上海地区临床化学室内质量控制的要求。方法 按美国CLIA′88可接受范围的四分之一作为上海地区拟推荐要求。对上海市 2003年 147家临床实验室 23项常规临床化学 3 570 336个室内质量控制数据进行整理和统计分析,计算出各项目变异系数 (CV)百分位数的均数,与卫生部1985年推荐的RCV的统计分析结果进行比较。结果 上海地区 138家临床实验室(占 94 .0% )CV小于卫生部 1985年推荐的RCV,约有 111家临床实验室 (占 75. 5 % )符合上海地区拟推荐的要求。结论 拟定的推荐要求基本适宜,不仅可被临床接受,而且已有 75 5%单位符合要求,但尚有 24 .5 % 单位须努力才能达到要求。

Objective Investigated and analyzed the data of routine coefficient of variation (R CV ) from clinical laboratories of the second and the third grade hospital, we have drawed up Internal Quality Control(IQC) requirement of clinical chemistry in Shanghai Methods In this survey, we defined IQC requirement a quarter of CLIA’88 proficiency testing criteria as acceptable analytical performance From 147 clinical laboratories, we get 3 570 336 IQC data of 23 analytes of clinical chemistry which was analyzed and percentiles were calculated The outcome from the statistical analysis was compared with recommendation from the Ministry of Health in1985 Results 138 clinical laboratories (94 0%) CV results in Shanghai were less than R CV recommendation from the Ministry of Health About 111 clinical laboratories (75 5%) results are according with IQC requirement Conclusion IQC requirement is suitable for the clinical laboratories in Shanghai 75 5% clinical laboratories accorded with IQC requirement and 24 5% clinical laboratories should improve technique to carry out the IQC requirement