Shiba N, Note R, Hayashi S, Ozawa T, Niiya K, Sakuragawa N
Department of Hospital Laboratory Medicine, Toyama Medical and Pharmaceutical University.
Rinsho Byori. 1997 Feb;45(2):175-8.
A new ELISA method for antinuclear antibody(ANA) test was investigated for its clinical usefulness by comparison with a widely used IF method. Both methods used Hep 2 cells as a substrate. ELISA method showed good reproducibility in both within-run(CV = 5.1 approximately 8.7%) and between-run(CV = 8.1 approximately 9.6%) assays. ROC analysis revealed that ELISA method had a higher sensitivity and an equal specificity as compared to IF method. Application of an auto analyzing system to ELISA method could induce the improvement of efficacy and labor saving. The coincidence rate between ELISA and IF methods was 78.6% on the samples from 887 patients with various disorders. In patients with drug induced lupus or connective tissue diseases except for rheumatoid arthritis, the discrepancies were caused mainly by the higher sensitivity of ELISA method. However, the ELISA test was less sensitive for the ANAs showing granular, nuclear membrane, or anti-PCNA antibody like staining patterns by IF method. In conclusion, ELISA method is useful for detecting ANAs because of its high sensitivity and efficiency, though it still has some points to be improved.
通过与广泛使用的间接免疫荧光法（IF法）比较，研究了一种新的抗核抗体（ANA）检测酶联免疫吸附测定（ELISA）方法的临床实用性。两种方法均使用Hep 2细胞作为底物。ELISA法在批内（变异系数[CV]=5.1%至8.7%）和批间（CV=8.1%至9.6%）检测中均显示出良好的重复性。ROC分析显示，与IF法相比，ELISA法具有更高的灵敏度和相同的特异性。将自动分析系统应用于ELISA法可提高效率并节省人力。对887例患有各种疾病患者的样本进行检测，ELISA法与IF法的符合率为78.6%。在药物性狼疮或除类风湿关节炎外的结缔组织病患者中，差异主要是由于ELISA法具有更高的灵敏度。然而，ELISA检测对IF法显示颗粒状、核膜或抗增殖细胞核抗原（PCNA）抗体样染色模式的ANA不太敏感。总之，ELISA法因其高灵敏度和高效率而有助于检测ANA，尽管仍有一些方面有待改进。
