抗双链DNA抗体与系统性红斑狼疮临床表型的相关性及4种试剂盒效能比较  

Correlation of systemic lupus erythematosus clinical phenotypes with anti-double-stranded DNA antibodies and performance comparison of 4 commercial determination kits

作　　者：宋睿[1] 叶萍[1] 魏朝晖 陈晓翔[1] 王久存[3] SONG Rui;YE Ping;WEI Chaohui;CHEN Xiaoxiang;WANG Jiucun(Renji Hospital,Shanghai Jiaotong University School of Medicine,Shanghai 200001,China;Innovent Biologics,Soochow 215123,Jiangsu,China;Department of Biological Science,Fudan University,Shanghai 200433,China)

机构地区：[1]上海交通大学医学院附属仁济医院,上海200001 [2]信达生物制药(苏州)有限公司,江苏苏州215123 [3]上海复旦大学生命科学学院,上海200433

出　　处：《检验医学》2017年第4期316-321,共6页Laboratory Medicine

摘　　要：目的对4种常用的抗双链DNA(dsDNA)抗体检测试剂盒进行效能比较,同时对抗dsDNA抗体与系统性红斑狼疮(SLE)15项典型临床表型进行相关性分析,以辅助SLE的临床诊断和病情监测。方法收集SLE患者229例,其他结缔组织病患者112例。整理各病例10项临床表型和5项实验室指标,计算SLE患者的疾病活动指数(SLEDAI)。用4种试剂盒[试剂盒A为间接免疫荧光法(IFA),试剂盒B、C均为酶联免疫吸附试验(ELISA),试剂盒D为放射免疫法]检测患者血清抗dsDNA抗体水平,对4种试剂盒的检测效能进行比较,同时对抗dsDNA抗体与各临床表型和实验室指标之间的相关性进行分析。结果 4种试剂盒的检测结果间差异均有统计学意义(P<0.01)。Youden指数最高的是试剂盒C,试剂盒B、D次之,试剂盒A最低;B、C、D 3种定量试剂盒的检测结果与SLE患者的SLEDAI具有相关性(r值分别为0.482、0.512、0.685,P<0.01)。在10项临床表型和5项实验室指标中,抗核小体抗体升高和补体下降与抗dsDNA抗体呈正相关(P<0.01);抗核抗体阳性(P<0.05)、狼疮肾炎(P<0.05)、白细胞减少(P<0.05)和颊部红斑(P<0.05)在2种试剂盒的检测结果中显示与抗dsDNA抗体呈正相关;而血小板减少、外周关节炎等8项与抗dsDNA抗体未显示相关性。结论 4种抗dsDNA抗体检测试剂盒检测性能差异较大。试剂盒C适用于疾病的初筛检测,试剂盒D可用于监测病情的活动度。狼疮肾炎、颊部红斑、抗核小体抗体、抗核抗体、补体降低、白细胞减少与抗dsDNA抗体关系密切。Objective To compare the performance of4commercial determination kits for anti-double-stranded DNA(dsDNA)antibodies,to analyze the correlation of15typical systemic lupus erythematosus(SLE)clinical phenotypes with anti-dsDNA antibodies,and to provide a reference for the diagnosis and monitoring of SLE.Methods A total of229SLE patients were enrolled,and112patients with other connective tissue diseases were enrolled.Their serum samples were collected.There were10typical SLE clinical phenotypes and5parameters.All SLE patients were evaluated according to SLE disease activity index(SLEDAI).The levels of anti-dsDNA antibodies were determined by4commercial determination kits[kit A using indirect immunofluorescence assay(IFA),kit B and kit C using enzyme-linked immunosorbent assay(ELISA)and kit D using radioimmunoassay].The performance of the4commercial determination kits was evaluated.The correlation of typical SLE clinical phenotypes and parameters with anti-dsDNA antibodies was analyzed.Results The results of4commercial determination kits had statistical significance(P<0.01).Kit C had the highest Youden's index,its Youden's index was higher than those of kit B and kit D,and that of kit A was the lowest.The results of kit B,C and D had correlations with SLEDAI(r=0.482,0.512and0.685,P<0.01).For10typical SLE clinical phenotypes and5parameters,anti-dsDNA antibodies were correlated positively with increasing anti-nucleosome antibody and decreasing complement(P<0.01).Theresults of positive anti-nuclear antibodies(P<0.05),nephropathy(P<0.05),leukopenia(P<0.05)and malar rash(P<0.05)in2kits were positively correlated with anti-dsDNA antibodies.The other8typical SLE clinical phenotypes,including thrombocytopenia and peripheral arthritis,showed no correlation with anti-dsDNA antibodies.Conclusions The performance of4commercial determination kits is different.Kit C is adapted to screen SLE,and kit D is suitable for monitoring the activity of SLE.Nephropathy,malar rash,anti-nucleosome antibody,anti-nuclear antibody,decreasing compl

关 键 词：抗双链DNA抗体 系统性红斑狼疮 临床表型 

分 类 号：R446.62[医药卫生—诊断学]