系统性红斑狼疮患者抗双链DNA抗体四种检测方法的比较研究  

Performance comparison of four anti-dsDNA antibodies assays in Chinese systemic lupus erythematosuspatients patients

作　　者：赵江峰[1] 王楷文[1] 王晓栋[1] 李挺[1] 郭丽[1] 顾立扬[1] 陈志威[1] 叶霜[1] 

机构地区：[1]上海交通大学医学院附属仁济医院南院风湿科,210002

出　　处：《中华风湿病学杂志》2017年第6期381-386,I0002,共7页Chinese Journal of Rheumatology

基　　金：国家自然科学基金（81601402）

摘　　要：目的 比较抗dsDNA抗体4种检测方法,即BioPlex磁珠包被多重免疫法,放射免疫分析法（Farr）,ELISA法（MBDEHSA,EURO-ELISA）,HOB-磁微粒化学发光法在SLE患者的检测效能,及其与疾病活动度的相关性分析和各类方法学最适截断值的判定.方法 选取SLE患者119例,疾病对照组100例,健康对照组200名进行抗dsDNA抗体检测,同时引入短膜虫间接免疫荧光法（CLIFF）,分析各方法学与其的一致性;分析不同方法测得抗dsDNA抗体表达量与疾病活动度的相关性;接受者操作特征曲线（ROC曲线）判定各方法学诊断的敏感度及特异度.结果 依据原厂试剂盒设定的截断值,BioPlex与HOB所测定的抗dsDNA结果,相比其他检测方法,与CLIFT结果总体一致性较高;ELISA （MBL/EURO）方法所测得的结果与CLIFF结果阳性一致性最好;在SLE疾病活动度评判上,Bioplex结果与疾病SLEDAI评分相关性最强（r=0.297 6,P=0.001 2）;在SLE是否合并LN 2组患者中,使用Bioplex方法检测抗dsDNA抗体表达量之间差异有统计学意义（P=0.026 8）;ROC曲线分析,Bioplex对于SLE患者体内抗dsDNA抗体检测效能最强.结论 相比其他方法,BioPlex在检测抗dsDNA抗体有较高的特异度,且与疾病活动度和肾脏受累有较好的相关性.Objective To compare the performance of four commercial anti-dsDNA antibody assays,i.e,BioPlex 2200 （BioPlex）,Farr radioimmunoassay （Farr）,MESACUP DNA-Ⅱ TEST ＆quot;ds＆quot; [MBL-enzyme linked immunosorbent assay （ELISA）] and Anti-dsDNA-NcX ELISA （IgG） （EURO-ELISA）,Antoantibodies Profile Assay Kit （HOB-Chemiluminescent Immunoassay） in disease activity assessment of systemic lupus erythematosus （SLE）.Methods SLE patients （n=119） as well as healthy controls （n=200） and disease controls （n=100） were recruited and their serum anti-dsDNA antibodies were detected by BioPlex,Farr,MBL-ELISA,EURO-ELISA,and a standard Crithidia luciliae indirect immunofluorescence test （CLIFT）.The consistency between above four methods to CLIFT was analyzed.The correlation of anti-dsDNA antibody level of these four methods to SLE disease activity was assessed.All data analyses were performed with Statistical product and service solutions （SPSS） 16.0 （SPSS.Inc） and GraphPad Prism 4.0.3 （GraphPad）.Unless otherwise specified,all data in this study were expressed as mean±standard deviation.Cut-off values of the anti-dsDNA quantification methods were set by the manufacturers.Chi square and kappa coefficients were adopted to assess the agreement determination and correlation analysis between anti-dsDNA level and SLE disease activity （SLEDAI）.Receiver-operator characteristic （ROC） curve analysis was used to compare the specificity and sensitivity of the anti-dsDNA assays.Student＇s t test was adopted for the comparison of anti-dsDNA levels by different methods between SLE and SLE＋LN groups.A p value small than 0.05 was considered statistically significant.Results Using cut-off values set by the manufacturers,BioPlex demonstrated the highest overall agreement with CLIFT,while MBL-ELISA and EURO-ELISA showed the highest positive agreement with CLIFT.Disease activity correlation analysis showed that SLEDAI score correlated poorly with anti-dsDNA level in Farr assay,but strongly

关 键 词：红斑狼疮 系统性 自身抗体 

分 类 号：R593.241[医药卫生—内科学]