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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 a reference interval of anti-double-stranded DNA antibody suitable for the population and detection system in this area by CLSI document C28-A3, which provides a reference for clinicians to diagnose systemic lupus erythematosus (SLE). Methods Based on the principle of healthy people in CLSI C28-A3 of the United States, 471 healthy men and women of different ages were selected respectively. Serum anti-dsDNA-NcX antibody levels were quantified using the anti-dsDNA-NcX antibody test kit from EUROIMMUN, Germany, and the ADDCARE 500 automated microplate reader from Yidekang, Shandong Province. The reference interval was estimated using the Bootstrap method based on the non-parametric and put-back sampling method. Results The statistical analysis showed that there was no significant difference in anti-dsDNA-NcX antibody levels between different sexes and ages (P> 0.05). Therefore, the data of the combined gender and age were analyzed and the upper limit of the medical reference interval was 53IU / mL. Conclusion Preliminary attempts to establish a healthy population in the area of anti-dsDNA-NcX antibody reference interval.