京津冀地区56家临床检验结果互认实验室18个常规化学项目参考区间结果分析  

Analysis of Reference Intervals of 18 Routine Biochemistry in 56 Mutual Recognition Laboratories in Beijing-Tianjing-Hebei Region

作　　者：李婷婷[1,2] 赵海建[1] 王薇[1] 何法霖[1] 钟堃[1] 袁帅[1] 王治国[1] 

机构地区：[1]北京医院国家老年医学中心卫生部临床检验中心/北京市临床检验工程技术研究中心,北京100730 [2]北京协和医学院研究生院,北京100730

出　　处：《现代检验医学杂志》2017年第6期154-159,共6页Journal of Modern Laboratory Medicine

基　　金：北京市自然科学基金资助项目(7143182);北京医院课题资助(BJ-2015-025)

摘　　要：目的通过分析京津冀地区检验结果互认实验室18个常规化学互认项目参考区间结果,评价互认实验室参考区间的一致性。方法实验室通过基于WEB方式的室间质量评价(EQA)软件系统上报参考区间相关信息,后台将回报数据另存为Microsoft Excel 2007文档,然后选出该次京津冀地区互认的实验室(56家)以及互认的18个常规生化项目,包括钾(K)、钠(Na)、氯(Cl)、钙(Ca)、磷(P)、总蛋白(TP)、清蛋白(ALB)、总胆固醇(TC)、三酰甘油(TG)、肌酐(CRE)、尿素(URE)、尿酸(UA)、葡萄糖(GLU)、丙氨酸氨基转氨酶(ALT)、天门冬氨酸氨基转氨酶(AST)、γ-谷氨酰基转移酶(GGT)、乳酸脱氢酶(LDH)和肌酸激酶(CK),并对这些项目的参考区间上下限及来源进行分析。结果实验室参考区间来源不一,对于有参考区间卫生行业标准的项目(包括K,Na,Cl,Ca,P,TP,ALB,CRE,URE,ALT,AST,GGT,LDH和CK)主要来源于行业标准(23.1%~48.1%),试剂/仪器厂家说明书(17.3%~41.8%)或《全国临床检验操作规程》(18.9%~37.0%);对于没有行业标准的项目(包括TC,TG,UA和GLU)主要来源于试剂/仪器厂家说明书(>41%)和《全国临床检验操作规程》(>45.3%)。超过一半的实验室(50.9%~58.9%)对引用的参考区间进行了验证。各实验室间K,Cl,Ca,P,GLU参考区间上下限相差较小,其他项目差异较大。结论互认实验室常规化学参考区间上下限存在不一致,为保证京津冀地区检验结果的可比性应建立基于区域性人群或中国人群的参考区间。Objective To evaluate reference intervals consistency of 18 routine biochemistry among mutual recognition labora-tories by analyzing the information of reference intervals of these laboratories in Beijing-Tianjing-Hebei region.Methods Laboratories submitted the data of reference intervals via interval quality assessment（EQA）software which was based on WEB,then the background of the software save the data as Microsoft Excel 2007 document.Finally,the mutual recognition routine biochemical projects,including Kalium（K）,Sodium（Na）,Chlorinum（Cl）,Calcium（Ca）,Phosphorus（P）,Total protein（TP）,Albumin（ALB）,Total cholesterol（TC）,Triglyceride（TG）,Creatinine（CRE）,Urea（URE）,Uric acid （UA）,Glucose（GLU）,Alanine amino transaminase（ALT）,Aspartate aminotransferase（AST）,γ-glutamyltranspeptidase （GGT）,Lactate dehydrogenase（LDH）and Creatine kinase（CK）of 56 mutual recognition laboratories were chosen,and perform analysis on upper and lower limits of reference intervals and their sources.Results The sources of reference inter-vals differ among different laboratories.As for projects owning hygiene professional standards（including K,Na,Cl,Ca,P, TP,ALB,CRE,URE,ALT,AST,GGT,LDH,CK）,the primary sources were hygiene professional standards（23.1%~48.1%）,manufacturer instructions of reagents/instrument（17.3%~41.8%）and National Clinical Laboratory Procedures （18.9% ~37.0%）,as for projects which didn＇t have professional standards（including TC,TG,UA and GLU）,the main sources were manufacturer instructions of reagents/instrument（〉41.1%）and National Clinical Laboratory Procedures（＆gt;45.3%）.Moreover,more than half of laboratories（50.9%~58.9%）had verified the reference intervals.There were little difference among laboratories in the upper and lower limits of Cl,Ca,P,K and GLU,but bigger difference for other projects. Conclusion The upper and lower limits of reference intervals werenot consistent among laboratories.In order to ensure the com

关 键 词：参考区间 检验 质量控制 生物化学 临床实验室 

分 类 号：R446[医药卫生—诊断学]