多个医院间不同检测系统胆红素检验结果的比对研究  

Comparative study and bias estimation on the results of serum bilirubin with different biochemical testing system among different hospitals

作　　者：刘晓春 黄钧 何毅 顾国龙[2] 杨霞芳[3] 周向阳 

机构地区：[1]广西临床检验中心,南宁530021 [2]广西中医学院瑞康医院,南宁530011 [3]广西壮族自治区人民医院,南宁530021

出　　处：《国际检验医学杂志》2009年第11期1060-1062,共3页International Journal of Laboratory Medicine

摘　　要：目的探讨多个医院间不同检测系统总胆红素(Tbil)和直接胆红素(Dbil)的可比性,为实现医院间检验结果的互认提供依据。方法参照EP9-A2文件,通过检测患者新鲜血清对6个自建检测系统的Tbil、Dbil与比较系统进行比对,计算自建检测系统和比较系统之间的相对偏差,以CLIA′88规定的室间质量评价可接受范围的1/2允许总误差为标准,判断是否为临床可接受。结果1)自建检验系统2的Dbil与比较系统间的相关系数(r)<0.975,与比较系统不具可比性;2)自建检测系统1 Tbil在24.1μmol/L与42.8μmol/L水平,Dbil在6.8μmol/L与29.8μmol/L水平。自建检测系统3的Dbil在6.8μmol/L与29.8μmol/L水平。自建检测系统4、6的Tbil在342μmol/L水平,Dbil在29.8μmol/L水平处的偏倚率均超过1/2允许总误差,与比较系统不具可比性。结论部分自建检测系统的胆红素结果与比较系统不具可比性,利用新鲜血对医院间非室间质评项目进行比对试验,对于保证医院间检验结果的可比性具有重要作用。Objective To study the result comparability of serum total bilirubin （Tbil） and di rect bilirubin （Dbil） on different biochemical detecting systems, so as to provide basis for mutual identification of test results among different hospitals. Methods According to CLSI EP9-A2 file, we analyzed the comparability of six self-built biochemical testing systems and aimed testing system by testing the fresh serum samples and calculating relative deviation. As a result, the correlation coefficient and the linear equation were obtained. The comparability of different investigating systems and clinical ac ceptability were judged according to CLIA＇88 standard （half of total error）. Results 1） There was no comparability of Dbil level between self-built testing system 2 and aimed testing system （r〈0. 975）. 2） The bias rates of self-built testing systems in different medical decision levels （system 1 at Tbil lev el 24.1 μmol/L and 42.8μmol/L, Dbil level 6.8 μmol/L and 29.8μmol/L; system 3 at Dbil level 6. 8 μmol/L and 29.8 μmol/L; system 4 and 6 at Tbil level 342 μmol/L, Dbil level 29.8 μmol/L） were all higher than the half of CLIA＇88 standard, and no comparability was found between self-built tes ting systems and aimed testing system. Conclusion There are no comparability of bilirubin level between partial self-built testing systems and aimed testing system. It is important for performing comparative test about non-quality assessment items to insure the comparability of test results among different hospitals.

关 键 词：胆红素 实验室 医院 偏差 临床实验室技术 

分 类 号：R446.112[医药卫生—诊断学]