CAJ | 학술논문

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24.1 μmol/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6.8/μmol/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.
목적 탐토다개의원간불동검측계통총담홍소(Tbil)화직접담홍소(Dbil)적가비성,위실현의원간검험결과적호인제공의거.방법 삼조EP9-A2문건,통과검측환자신선혈청대6개자건검측계통적Tbil、Dbil여비교계통진행비대,계산자건검측계통화비교계통지간적상대편차,이CLIA'88규정적실간질량평개가접수범위적1/2윤허총오차위표준,판단시부위림상가접수.결과 1)자건검험계통2적Dbil여비교계통간적상관계수(r)<0.975,여비교계통불구가비성;2)자건검측계통1 Tbil재24.1 μmol/L여42.8μmol/L수평,Dbil재6.8μmol/L여29.8μmol/L수평.자건검측계통3적Dbil재6.8/μmol/L여29.8μmol/L수평.자건검측계통4、6적Tbil재342μmol/L수평,Dbil재29.8μmol/L수평처적편의솔균초과1/2윤허총오차,여비교계통불구가비성.결론 부분자건검측계통적담홍소결과여비교계통불구가비성,이용신선혈대의원간비실간질평항목진행비대시험,대우보증의원간검험결과적가비성구유중요작용.
Objective To study the result comparability of serum total bilirubin(Tbil)and direct 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 acceptability 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 level 24.1 μmol/L and 42.8μmol/L,Dbil level 6.8μmol/L and 29.8μmol/L;system 3 at Dbil level 6.8μmol/L and 29.8μmol/L;system 4 and 6 at Tbil level 342μmol/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 tesring 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.