García Lerma J G, Mendoza A Z, Ramos M J, Sequí J
Department of Immunology, Centro Nacional de Investigación Clínica y Medicina Preventiva, Instituto Carlos III, Madrid, Spain.
J Clin Lab Anal. 1995;9(1):52-8. doi: 10.1002/jcla.1860090110.
This study comprises an analysis of the diagnostic usefulness of Ro/SSA, La/SSB, Sm and U1 RNP autoantigens obtained by DNA recombinant technology. We studied the presence of these autoantibodies in 33 patients with systemic lupus erythematosus (SLE) and 30 normal individuals by enzyme-linked immunosorbent assay (ELISA) using recombinant autoantigens and by Western immunoblot with these same antigens obtained from natural sources (rabbit thymus and human spleen). The strength of agreement between results found with these two techniques was moderate in the case of anti-Ro/SSA (kappa = 0.474, P < 0.001) and anti-U1 RNP (kappa = 0.566. P < 0.001) antibodies and almost perfect in the case of anti-La/SSB (kappa = 0871, P < 0.001) and anti-Sm (kappa = 0.833, P < 0.001). Furthermore, analysis of the disagreement between the two techniques evidenced a measurement bias for anti-Ro/SSA and anti-U1 RNP antibodies (Mc NEMAR'S statistic 13 and 11, respectively) whose direction, though difficult to define in the absence of a gold standard for such determinations, could be accounted for by the ELISA technique's greater tendency to produce positive results. Our conclusion is that the diagnostic usefulness of recombinant La/SSB and Sm autoantigens has been satisfactorily proven, whereas the case of the Ro/SSA and U1 RNP systems should be subject to further in-depth study of the autoepitopes recognised and the possible modifications which the latter might undergo as a result of their obtension from procariotic sources.
本研究包括对通过DNA重组技术获得的Ro/SSA、La/SSB、Sm和U1 RNP自身抗原的诊断效用进行分析。我们通过使用重组自身抗原的酶联免疫吸附测定(ELISA)以及使用从天然来源(兔胸腺和人脾脏)获得的相同抗原进行的Western免疫印迹法,研究了33例系统性红斑狼疮(SLE)患者和30名正常个体中这些自身抗体的存在情况。对于抗Ro/SSA(kappa = 0.474,P < 0.001)和抗U1 RNP(kappa = 0.566,P < 0.001)抗体,这两种技术所得结果之间的一致性强度为中等,而对于抗La/SSB(kappa = 0.871,P < 0.001)和抗Sm(kappa = 0.833,P < 0.001)抗体,一致性几乎完美。此外,对两种技术之间差异的分析表明,抗Ro/SSA和抗U1 RNP抗体存在测量偏差(Mc NEMAR统计量分别为13和11),尽管在缺乏此类测定的金标准的情况下难以确定其偏差方向,但ELISA技术产生阳性结果的倾向更大可能是造成这种偏差的原因。我们的结论是,重组La/SSB和Sm自身抗原的诊断效用已得到令人满意的证明,而Ro/SSA和U1 RNP系统的情况应进一步深入研究其识别的自身表位以及由于从原核生物来源获得而可能发生的潜在修饰。