我国血清总胆红素和直接胆红素检验项目参考区间现状与即将发布行业标准的分析比较

Analysis and Comparison of Reference Intervals of Serum Total Bilirubin and Serum Direct Bilirubin with Upcoming Industry Standards in China

目的分析我国临床实验室血清总胆红素(total bilirubin,TBIL)、直接胆红素(direct bilirubin,DBIL)检验项目的参考区间现状,并与即将发布的行业标准WS/T404第4部分进行比较。方法采用基于Web方式的室间质量评价(EQA)软件,收集参加卫生部临床检验中心2014年全国临床常规化学血清TBIL,DBIL项目EQA活动中的所有临床实验室的参考区间相关信息,包括参考区间来源、分组与验证情况、上下限、所用仪器、试剂、方法和校准物等。使用Microsoft Excel 2010和SPSS 19.0统计软件对数据进行统计分析。采用单样本均数t检验比较实验室使用参考区间与即将发布行业标准的差异;并根据检测系统对来源比例最高的实验室中的配套实验室进行分组,选取其中使用较多的3种配套系统所用参考区间分别与即将发布行业标准进行比较。结果纳入TBIL和DBIL项目参考区间来源分布调查的实验室分别为749和709家;其中分布比例最高的均是试剂厂家说明书(TBIL 58.08%,DBIL 58.67%),其次是《全国临床检验操作规程》(3版)(TBIL 29.64%,DBIL 28.91%),其他来源不足10%;验证参考区间的比例分别是50.60%和49.93%。各项目实验室使用参考区间上、下限分别与即将发布行业标准参考区间上、下限比较,差异有统计学意义(P<0.05)。各项目实验室使用参考区间均比即将发布行业标准窄。血清TBIL,DBIL项目参考区间来源为试剂厂家说明书的实验室中,使用配套系统的实验室分别占41.88%和41.48%;单样本均数t检验结果显示,除Beckman检测系统对应的血清DBIL项目参考区间下限(P=0.068)和HITACHI检测系统对应的血清DBIL项目参考区间上限(P=0.087)以外,各配套检测系统对应的各项目参考区间上下限与行业标准的差异均有统计学意义(P<0.05)。结论目前我国临床实验室血清TBIL,DBIL项目参考区间使用情况不够科学合理,与即将发布行业标准比较差异有统计学意义。应该尽快发布行业标准WS/T404第4部分,帮助临床实验室建立合适的参考区间,促进参考区间使用规范化。

Objective To analyze the reference intervals of serum total bilirubin （TBIL） and serum direct bilirubin （DBIL） by all Chinese clinical laboratories and make a comparison with the upcoming part 4 of Industry Standard WS/T 404. Methods Relevant information about reference intervals of all clinical laboratories participating in TBIL and DBIL testing items of 2014 national external quality assessment scheme of clinical routine chemistry was collected by a web-based external quality assessment software, including source ,grouping, verification, upper and lower limits of reference intervals and instruments, reagents,methods and calibrators used. Microsoft Excel 2010 and SPSS 19.0 were applied to statistical analysis. The comparison between reference intervals used and the upcoming Industry Standard was conducted by the simple mean t test. Laboratories derived from the highest percentage of source distribution whose reagent and instrument were matching with each other were grouped according to the test systems used and the differences of reference intervals between three mainly used test systems and the upcoming Industry Standard were also compared with the single sample mean t test. ResuLts The number of laboratories participated in the investigation about source distribution of reference intervals for TBIL and DBIL was 749 and 709 respectively. For these two items, the highest sources were both instructions of reagent（TBIL 58. 08% ,DBIL 58.67 % ）,next were both National Clinical Laboratory Operation Rules （3rd Edition） （TBIL 29.64 %, DBIL 28.91%）, the percentages of other sources were all less than 10 %. Besides, there were respectively 379 （50.60 %） and 354 （49.93 % ） laboratories verifying their reference intervals for TBIL and DBIL. The difference of the comparison between reference intervals used and the upcoming Industry Standard had statistical significance （P〈0.05）. The using reference intervals were narrower than the upcoming Industry Standard for both items. In all laboratories with reference intervals from instructions of reagent, themating laboratories respectively accounted for 41.88 M and 41.48 % for item TBIL and DBIL. As the single sam- ple mean t test showed,the comparison of the reference intervals between three mainly used test systems in these mating la- boratories and the upcoming Industry Standard had statistical significance （P〈0.05）, except for the lower limit of DBIL with Beckman test system （P value was 0. 068） and the upper limit of DBIL with HITACHI test system （P value was 0. 087）. Conclusion Currently,the using situation of reference intervals about TBIL and DBIL by all Chinese laboratories was not scientific and rational enough and has significant difference with the upcoming Industry Standard. Should publish the part 4 of Industry Standard WS/T 404 as soon as possible,which would help clinical laboratories establishing suitable reference intervals and promote the standardization of its usage.