血清抗dsDNA抗体参考区间的探讨

Study on the reference interval of anti-dsDNA antibody in serum

目的应用美国临床和实验室标准化协会(CLSI)文件C28-A3,建立适合该地区人群和检测系统的抗双链DNA抗体的参考区间,为临床医生诊断系统性红斑狼疮(SLE)提供参考。方法依据美国CLSI C28-A3文件关于健康者的原则要求,分别选择该地区不同年龄段健康男女共471例。使用德国EUROIMMUN公司的抗dsDNA-NcX抗体检测试剂盒以及山东省烟台爱得康公司的ADDCARE500全自动酶标仪定量测定血清抗dsDNA-NcX抗体水平。采用基于非参数有放回的抽样方法(Bootstrap法)估计参考区间。结果经统计学分析,不同性别、年龄的抗dsDNA-NcX抗体水平差异无统计学意义(P>0.05),因此对数据合并性别、年龄后进行分析,推断的医学参考区间的上限值为53IU/mL。结论初步尝试建立了该地区健康人群血清抗dsDNA-NcX抗体的参考区间。

Objective To establish reference interval of anti-dsDNA antibody applicable to local population and detection system according to CLSI C28-A3 proposed by the Clinical and Laboratory Standards Institute,so as to provide a reference for clinical diagnose systemic lupus erythematosus（SLE）.Methods According to guideline of C28-A3,a total of 471 local apparently healthy individuals were enrolled and stratified by gender and age.Anti-dsDNA-NcX antibody level was quantitatively determined using the anti-dsDNA-NcX antibody assay kit（EUROIMMUN,Germany）,and the automatic microplate analyzer（ADDCARE500）.Non-parametric method（Bootstrap method）was used to analyze the reference interval.Results There were no significant difference in antidsDNA-NcX antibody level between male and female（P〉0.05）,and no correlation between anti-dsDNA-NcX antibody level and age（P〉0.05）.Therefore,data of different genders and ages were combined and analyzed as a whole.The 97.5 percentile upper limit of the reference interval was inferred to be 53 IU/mL.Conclusion The reference interval of serum anti-dsDNA-NcX antibodies based on local population is preliminarily established.