不同方法联合检测SLE患者血清中双链DNA抗体的性能评估

An assessment on diagnostic efficacy of different methods in combination for the detection of anti-dsDNA antibody in SLE patients

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。

Objective To investigate the prevalence of anti-dsDNA antibody in several autoimmune diseases,and evaluate the diagnostic efficacy of ELISA and indirect immunofluorescence（IIF）techniques for the detection of anti-dsDNA antibody in SLE patients.Methods Using commercially available kits based on ELISA（ELISA1,ELISA2）and IIF techniques simultaneously,serum anti-dsDNA antibody was determined in 300 SLE patients,495non-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 evaluated.Results The positive rates of anti-dsDNA antibody in SLE patients detected by ELISA1,ELISA2 and IIF kit were42.3%,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 0.672,0.398,0.512respectively（P〈0.05）.A significant difference was only observed between ELISA1 and ELISA2（P=0.003）.The area under the receiver 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%and0.764 in SLE patients.When three kinds of kits were used in combination,the highest positive rate and AUC were 57.7% and0.781.Conclusion Using ELISA and IIF in combination to detect anti-dsDNA antibody could greatly improve the efficacy for the diagnosis of SLE.