临床实验室多台生化分析仪极差法比对中分析质量要求研究  

Analytical quality requirement of range comparison for multiple biochemical analyzers in clinical laboratories

作　　者：谢文阁[1] 李稳[1] 黄宁[1] 李金星[1] XIE Wenge LI Wen HUANG Ning LI Jinxing.Department of Clinical Laboratory the Affiliated Hospital of Shandong University of Traditional Chinese Medicine;Jinan 250011;Shandong;China）

机构地区：[1]山东中医药大学附属医院检验科,山东济南250011

出　　处：《检验医学》2018年第8期760-763,共4页Laboratory Medicine

摘　　要：目的比较生物学变异、实验室内长期不精密度及允许变异系数(CV)在极差法比对中的应用确定合适的判断标准。方法按照WS/T 407—2012制定极差法比对方案。用新鲜血清制作标本,高、低2个水平,在3台生化分析仪上检测19个常规生化项目。结果 19个常规生化项目同一水平的实验室内长期不精密度及合成CV均<允许CV,50%的合成CV>1/3个体内生物变异;每个项目的比对偏差都<允许CV;有50%的比对偏差>1/3个体内生物变异;20%的比对偏差>临界极差。结论允许CV最适合作为判断标准,但属于异类相比(极差和标准差);中间精密度临界极差是同类相比,但稍严格,作为标准可与允许CV联合使用;1/3个体内生物变异属于异类相比且较严格,不适合作为判断标准。Objective To evaluate biological variations,laboratory internal long-term imprecision and allowable coefficient of variation（CV） in range comparison,and to determine appropriate criteria for judgement.Methods According to WS/T 407—2012,the scheme of range comparison was established. With high-level and low-level of patients＇ fresh sera,19 biochemical items were determined by 3 biochemical instruments.Results For the 19 biochemical items,laboratory internal long-term imprecision and combined CV at the same level were 〈 allowable CV,and 50% combined CV was 〉1/3 biological variation. Each comparison deviation was 〈 allowable CV,and 50% comparison deviation was 〉1/3 biological variation. The 20% comparison deviation was 〉 critical range.Conclusions Allowable CV can be used as a criterion for judgement,which is non-congener comparison（range comparison and standard deviation）. The critical range belongs to congener comparison,which is strict slightly and can be used as a criterion for the combined usage with allowable CV. 1/3 Biological variation belongs to congener comparison and is too strict to be used as a criterion for judgement.

关 键 词：分析质量要求 极差法比对 可比性 精密度 允许变异系数 

分 类 号：R446.5[医药卫生—诊断学]