Objective To validate the clinical applicability of the published standard reference interval of routine clinical chemistry(WS/T 404.1-2012,WS/T 404.1-2012) based on the results of health examination.Methods This was a retrospective study.The results of serum TP(Biuret),ALB (BCG),ALT(Rate without 5'-pyridoxal phosphate),AST (Rate without 5'-pyridoxal phosphate),ALP (Rate,AMP),GGT(Rate) from healthy examinatiou individuals (from January to July,2013) were collected to calculate the 2.5％ and 97.5％ pereentiles,excluding the significant abnormal results according to the Medical Deciding Level 2 recommended by Staland.The number of the cases after excluding were 19 708(M 12 044,F 7 664) 、19 728(M 12 069,F 7 659) 、45 569(M 26 299,F 19 270) 、45 877(M 26 739,F 19 138)、5 965(M 4 208,F 1 757)、4 726(M 3 164,F 1 562),respectively.The proportions of all the examined results (with and without the excluded results) that fell in the published standard reference interval were also calculated.Results The test of normality revealed that the frequency distributions of all verified items were skewed distributions after excluded the abnormal results.The 2.5％-97.5％ percentiles of TP,ALB,ALT(M),ALT(F),AST (M),AST (F),ALP (F20-49),ALP (F50-79),GGT (M) and GGT (F) were 64-79 g/L,40-59 g/L,9-52 U/L,7-39 U/L,13-41 U/L,12-33 U/L,42-116 U/L,36-98 U/L,44-130 U/L,11-72 U/L and 7-50 U/L respectively.More than 90％ results of TP,ALB,ALT(M),ALT(F),AST (M),AST(F),ALP(F20-49),ALP(F50-79),GGT(M) and GGT(F) (with and without the excluded results) fell in the reference intervals of national standards,GGT(M) was 80％ and 91％.Conclusions The published standard reference interval of routine clinical chemistry (WS/T 404.1-2012,WS/T 404.1-2012) are applicable to our laboratory.%目的 应用健康体检对象血清TP、ALB、ALT、AST、ALP、GGT检验结果验证参考区间行业标准(WS/T 404.1-2012、WS/T 404.1-2012)的临床适用性.方法 回顾性研究收集2013年1月至7月安徽医科大学第一附属医院18 ～ 79岁(中位年龄40 ～ 44岁)健康体检对象血清TP(双缩脲法)、ALB(溴甲酚绿法)、ALT(速率法,不含5'-磷酸吡哆醛)、AST(速率法,不含5'-磷酸吡哆醛)、ALP(速率法,AMP)、GGT(速率法)检验结果,按Staland建议的医学决定水平2剔除有明显异常结果后,例数分别为19 708(男12 044,女7 664)、19 728(男12 069,女7 659)、45 569(男26 299,女19 270)、45 877(男26 739,女19 138)、5 965(男4 208,女1 757)、4 726(男3 164,女l 562),统计其2.5、97.5百分位数,同时计算剔除前后上述各验证项目检验结果例数在参考区间行业标准范围内所占百分比.结果 正态性检验结果表明体检对象血清各验证项目检测结果频数分布均呈偏态分布,其血清TP、ALB、ALT(M)、ALT(F)、AST(M)、AST(F)、ALP(M)、ALP(F20-49)、ALP(F50-79)、GGT(M)、GGT(F)2.5 ～97.5百分位数分别为64 ～ 79g/L、40 ～53g/L、9～ 52U/L、7～ 39U/L、13 ～41U/L、12 ～33 U/L、42 ～116 U/L、36 ～98 U/L、44～130 U/L、11 ～72 U/L、7～ 50 U/L,且剔除前后90％以上体检对象血清TP、ALB、ALT(M)、ALT(F)、AST(M)、AST(F)、ALP(M)、ALP(F20-49)、ALP(F50-79)、GGT(F)检验结果均在行业标准范围内,而GGT(M)剔除前后则分别为80％和91％.结论 参考区间行业标准适用于本实验室.
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