Objective To compare the performance of 4 commercial determination kits for anti-double-stranded DNA (dsDNA)antibodies,to analyze the correlation of 15 typical 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 of 229 SLE patients were enrolled,and 112 patients with other connective tissue diseases were enrolled. Their serum samples were collected. There were 10 typical SLE clinical phenotypes and 5 parameters. All SLE patients were evaluated according to SLE disease activity index (SLEDAI). The levels of anti-dsDNA antibodies were determined by 4 commercial 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 the 4 commercial determination kits was evaluated. The correlation of typical SLE clinical phenotypes and parameters with anti-dsDNA antibodies was analyzed. Results The results of 4 commercial determination kits had statisticalsignificance(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, 0.512 and 0.685,P<0.01). For 10 typical SLE clinical phenotypes and 5 parameters,anti-dsDNA antibodies were correlated positively with increasing anti-nucleosome antibody and decreasing complement (P<0.01). The results of positive anti-nuclear antibodies (P<0.05),nephropathy (P<0.05),leukopenia (P<0.05) and malar rash(P<0.05) in 2 kits were positively correlated with anti-dsDNA antibodies. The other 8 typical SLE clinical phenotypes,including thrombocytopenia and peripheral arthritis,showed no correlation with anti-dsDNA antibodies. Conclusions The performance of 4 commercial 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 complement and leukopenia are correlated with anti-dsDNA antibodies.%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.
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