化学发光法测抗SS-A抗体、抗SS-B抗体的应用评价

Evaluation of Chemiluminescence Immunoassay in Detection of Anti-SS-A and Anti-SS-B

目的评价化学发光法(CLIA)检测抗SS-A抗体Ig G和抗SS-B抗体Ig G的临床应用价值。方法收集276例自身免疫性疾病患者血清,采用双盲法分别用线性免疫印迹法(LIA)和CLIA法进行测试抗SS-A抗体Ig G和抗SS-B抗体Ig G,以LIA法为参照,计算CLIA的阴阳性符合率。两种方法阴阳性不符的样本用酶联免疫吸附法(ELISA)复测。并收集202例系统系红斑狼疮患者和140例干燥综合征患者血清用CLIA法进行测试,统计疾病阳性检出率。结果以LIA法为参照,抗SS-A抗体Ig G CLIA法阳性符合率为98.4%,阴性符合率为97.3%,Kappa为0.956,两种方法一致性较好。两种方法不一致的6例样本用ELISA确认均与CLIA结果一致;抗SS-B抗体Ig G CLIA阳性符合率为95.7%,阴性符合率为98.1%,Kappa为0.933,两种方法一致性较好。两种方法不一致的7例样本用ELISA确认4例与CLIA结果一致。202例系统性红斑狼疮血清样本,用CLIA法测抗SS-A抗体Ig G阳性检出率为58.9%,抗SS-B抗体Ig G阳性检出率为17.3%。140例干燥综合征血清样本,用CLIA法测抗SS-A抗体Ig G阳性检出率为88.6%,抗SS-B抗体Ig G阳性检出率为85.7%,均与文献报道一致。结论 CLIA法和LIA法,ELISA法具有较好的一致性和符合率,并且疾病的阳性检出率符合要求。与其他两种方法相比,CLIA实现了真正的定量,真正的全自动,且随机上样、灵活组合,更加满足临床应用的要求。

Objective To evaluate the clinical value of chemiluminescence immunoassay （CLIA） in detection of Anti-SS-A IgG and Anti-SS-B IgG. Methods A Total of 276 serum samples with autoimmune diseases were selected to detect the Anti-SS-A IgG and Anti-SS-B IgG using Line immunoassay （LIA）and CLIA with double blind approach. The performance of CLIA was evaluated by using LIA as the ＂gold standard＂. All discrepant samples were retested using enzyme-linked immunosorbent assay （ELISA）. A total of 202 serum samples with systemic lupus erythematosus and 140 serum samples with sjogren syndrome were selected to calculate the sensitivity of the disease. Results CLIA method showed good agreement for anti-SS-A IgG and anti-SS-B IgG values with LIA method. For Anti-SS-A IgG, the positive agreement, negative agreement and Kappa were 98.4%, 97.3% and 0. 956 respectively. Six discrepant samples were retested using the ELISA, whose results were all consistent with CLIA. For Anti-SS-B IgG, The positive agreement, negative agreement and Kappa were 95.7% and 98.1% and 0. 933 respectively, Seven discrepant samples were retested using ELISA,4 cases of the results were consistent with CLIA. Out of 202 cases with systemic lupus,erythematosus were detected with 58.9% positive of anti-SS-A IgG and 17.3% positive of anti-SS-B IgG by CLIA. Out of 140 sera with Sjogren syndrome, we detected 88.6% positive of anti-SS-A IgG and 85.7% positive of anti-SS-B IgG by CLIA. The results were consistent with the literature report. Conclusion Good correlation was found between LIA and CLIA methods. Compared with other two methods, CLIA is merited for its quantitative ability, fast and convenient procedure as well as its wider measurement spectrum.