两种方法检测抗双链DNA抗体的临床对比研究

Clinical comparison and study of two methods for detection of antibodies against double stranded DNA

目的比较化学发光法(CLIA)与酶联免疫吸附法(ELISA)抗双链DNA抗体的临床检测性能。方法应用CLIA和ELISA对103例系统性红斑狼疮(SLE)确诊患者、222例非狼疮疾病对照组(non-SLE)和88例体检对照组(HI)开展抗双链DNA抗体平行检测,比较两种方法的定性符合率和抗体量值相关性,同时以SLE诊断为标准绘制ROC曲线分析两种检测方法临床疾病诊断的准确度。结果两种方法检测抗双链DNA抗体时,总符合率为84.0%(95.0%置信区间80.1%~87.4%),一致性结果显示kappa=0.53(P<0.01)。两种方法针对SLE患者的检测量值相关系数rho=0.646(P<0.01)。ROC曲线分析显示CLIA和ELISA曲线以下面积(AUC)分别为0.943(P<0.01)和0.893(P<0.01)。结论CLIA与ELISA在检测抗双链DNA抗体时具有较好的符合率、一致性和量值相关性。ROC结果显示CLIA检测结果对于SLE诊断准确性更高。

Objective To compare the clinical performance of chemiluminescent immunoassay(CLIA)and Enzyme linked immunosorbent assay(ELISA)for the detection to anti-double stranded DNA antibodies.Methods Sera from patients who suffered from systemic lupus erythematosus(SLE,n=103),Non-SLE rheumatic disease served as control group(Non-SLE,n=222)and healthy individual served ascontrol group(HI,n=88)were collected and tested with CLIA and ELISA in parallel for autoantibodies to double stranded DNA.The qualitative agreement and quantitative correlation between CLIA and ELISA were compared.ROC analysis were used to compare SLE diagnostic accuracy of the result from these two methods.Results The overall agreement of CLIA and ELISA for the detection of anti-dsDNA antibody was 84%(95%CI 80.1%-87.4%)with a Kappa value of 0.53(P<0.01).The spearman rho value for quantitative correlation between these two methods was 0.646(95%CI 0.517-0.746,P<0.01).ROC analysis showed that areas under the curve(AUC)value for SLE diagnosis were 0.943(P<0.01)for CLIA and 0.893(P<0.01)for ELISA.Conclusion The overall qualitative agreement and quantitative correlation between CLIA and ELISA on the detection to anti-dsDNA antibody is comparable,the result of ROC analysis shows that CLIA is superior to ELISA for identifying SLE patients.