不同方法联合检测 SLE 患者血清中双链 DNA 抗体的性能评估

摘要

Objective To investigate the prevalence of anti-dsDNA antibody in several autoimmune diseases ,and evaluate the di-agnostic efficacy of ELISA and indirect immunofluorescence (IIF) techniques for the detection of anti-dsDNA antibody in SLE pa-tients .Methods Using commercially available kits based on ELISA (ELISA1 ,ELISA2) and IIF techniques simultaneously ,serum anti-dsDNA antibody was determined in 300 SLE patients ,495 non-SLE autoimmune disease patients ,and 300 health controls .The efficacy of anti-dsDNA antibody determined by one method or combined methods for the diagnostic of SLE patients was further e-valuated .Results The positive rates of anti-dsDNA antibody in SLE patients detected by ELISA1 ,ELISA2 and IIF kit were 42 .3% ,35 .3% and 38 .0% respectively .An utmost prevalence in the non-SLE patients and health controls were 1 .2% and 0 .3%respectively .In SLE patients ,Kappa values of ELISA1 and ELISA2 ,ELISA1 and IIF ,ELISA2 and IIF were 0 .672 ,0 .398 ,0 .512 re-spectively(P< 0 .05) .A significant difference was only observed between ELISA1 and ELISA2(P= 0 .003) .The area under the re-ceiver operating curve (AUC)of ELISA1 ,ELISA2 and IIF were 0 .708 ,0 .672 and 0 .687 respectively ,based on the result obtained from individual method .when ELISA1 kit and IIF kit were used in combination ,the highest positive rate and AUC were 54 .7% and 0 .764 in SLE patients .When three kinds of kits were used in combination ,the highest positive rate and AUC were 57 .7% and 0 .781 .Conclusion Using ELISA and IIF in combination to detect anti-dsDNA antibody could greatly improve the efficacy for the diagnosis of SLE .%目的：探讨双链 DNA 抗体（dsDNA 抗体）在常见自身免疫性疾病中的检出情况，评估不同方法联合检测系统性红斑狼疮（SLE）患者血清中 dsDNA 抗体的性能。方法使用 ELISA 法（ELISA1、ELISA2）和间接免疫荧光（IIF）法同时检测300例SLE 和495例非 SLE 自身免疫疾病患者，以及300例健康体检者血清 dsDNA 抗体，分析单独和联合使用不同方法检测 dsDNA抗体对 SLE 的诊断效能。结果 ELISA1、ELISA2和 IIF 在 SLE 患者中的检出率分别为42．3％、35．3％和38．0％，在非 SLE 自身免疫性疾病患者中最高检出率为1．2％，在健康体检人群中最高为0．3％。在 SLE 人群，3种方法中 ELISA1和 ELISA2法， ELISA1和 IIF 法，以及 ELISA2和 IIF 法联合 Kappa 值分别为0．672、0．398和0．512（P＜0．05）。而只有 ELISA1和 ELISA2间的检测率差异有统计学意义（P＝0．003）。 ELISA1、ELISA2和 IIF 法检测 dsDNA 抗体的受试者工作特征曲线下面积（AUC）分别为0．708、0．672和0．687；ELISA1和 IIF 法的联合检出率最高为54．7％，AUC 为0．764；3种方法同时检测，任何1种方法阳性即判断为阳性时，检出率为57．7％，AUC 为0．781。结论联合使用 ELISA 法和 IIF 法，可以明显提升 dsDNA 抗体在 SLE 中的检出率。