化学发光法与免疫印迹法检测抗SSA和SSB抗体的临床对比研究

The comparison between chemiluminescent immunoassay and line immunoassay for the detection to anti-SSA and SSB autoantibodies

目的比较化学发光法(CLIA)与免疫印迹法(LIA)针对抗SSA和SSB抗体的临床检测性能。方法应用CLIA和LIA对255例系统性红斑狼疮(SLE)、34例干燥综合征(SjS)、40例类风湿关节炎(RA)、25例系统性硬化症(SSc)及60例体检对照(HI)样本开展抗SSA和SSB抗体平行检测。比较两种方法抗SSA和SSB抗体的检测性能和符合率。并对两种方法检测结果的差异样本,采用第三种检测方法(ELISA)进行对比复测。结果两种方法检测抗SSA抗体时,总符合率为96.3%(Kappa=0.92,P<0.01)。而在抗SSB抗体则为95.8%(Kappa=0.85,P<0.01)。两种方法的差异样本(包括抗SSA和SSB抗体)合计33例,其中21例样本ELISA复测结果与CLIA检测结果相符合。结论 CLIA与LIA在检测抗SSA和SSB抗体时具有良好的符合率和一致性。由于具备全自动、定量检测和随机上样等显著特点,因此CLIA更适合临床抗SSA和SSB抗体检测。

Objective To compare the clinical performance of chemiluminescent immunoassay（CLIA）and line immunoassay（LIA）for testing to anti-SSA and SSB autoantibodies.Methods Sera from patients who suffered from systemic lupus erythematosus（SLE,n=255）,sjgren′s syndrome（SjS,n=34）,rheumatoid arthritis（RA,n=40）,systemic sclerosis（SSc,n=25）and healthy individual（HI,n=60）were collected and tested with CLIA and LIA in parallel for autoantibodies to SSA and SSB.The clinical performance and qualitative agreement between CLIA and LIA were compared.All discrepant samples were retested by ELISA as comparator method.Results CLIA and LIA showed excellent qualitative agreements on the detection of anti-SSA and anti-SSB.The overall agreements were 96.3%for anti-SSA and 95.8%for anti-SSB with a Kappa value of0.92 and 0.85（P〈0.01）,respectively.There were 33 discrepant samples between CLIA and LIA.21/33 of retested samples（by ELISA）agreed with CLIA results.Conclusion Excellent qualitative agreement between CLIA and LIA on the detection to anti-SSA and anti-SSB was found.With the additional benefit of automation,quantitative determination and random-access,CLIA is a preferable alternative platform for the detection of anti-SSA and SSB antibodies in clinical practice.