Hayashi Nobuhide
Rinsho Byori. 2016 Jun;64(6):701-708.
Antinuclear antibody (ANA) testing is indispensable for diagnosing and estimating clinical conditions of autoimmune diseases. This literature explains the usability and problem points regarding routine laboratory tests with examples of our own experiments regarding ANA diagnostics with some new technologies. The indirect immunofluorescence assay (IFA) is the gold standard for ANA screening, and it can detect more than 100 different antibodies, including the anti-proliferating cell nuclear antigen as well as anti- cytoplasmic antibodies. However, complicated procedures of conventional IFA and visual interpretation require highly skilled laboratory staff. The EUROPattern Cosmic IFA System (EUROIMMUN, Cosmic Corporation) and HELIOS* (Aesku Diag- nostics, MBL), which are computer-aided microscope systems for ANA testing, showed concordance of the positivity rate as high as 93.3 and 91.9%, respectively, and concordance of the antibody titer as high as 94.0 and 98.8%, respectively (within +/-1 titer) compared with the conventional method, on the measurement of different populations for each system. Although the computer-aided microscope system is not considered a complete system and laboratory staff should verify each result, it is a useful system for routine ANA analysis because it contributes to ANA stand- ardization and an efficient workflow. In our previous study, we demonstrated that BioPlex2200 (Bio-Rad), a fully automated immunoassay ana- lyzer using suspension bead array technology, was useful for the clinical diagnosis of autoimmune diseases. As an ANA screening test, the positive rate was low (7.2%) in healthy subjects, and comparable with that of IFA ( X160). The prevalence of disease-specific ANA in connective tissue disease patients was comparable with the general occurrence rate except for anti-dsDNA antibody in SLE. In accordance with the results of double immunodiffusion and Western blotting with the conventional method, the concordance rate between BioPlex2200 and conventional methods was high (95.0-100%) except for anti-dsDNA antibody. To provide high-quality and prompt clinical tests while considering the efficiency of working and cost reduc- tion, each laboratory should actively innovate and operate these advanced inspection technologies. [Review].
抗核抗体（ANA）检测对于自身免疫性疾病的诊断和临床状况评估不可或缺。本文通过我们自身关于ANA诊断的一些新技术实验示例，阐述了常规实验室检测的可用性和问题点。间接免疫荧光法（IFA）是ANA筛查的金标准，它能检测100多种不同抗体，包括抗增殖细胞核抗原以及抗细胞质抗体。然而，传统IFA的复杂操作程序和视觉判读需要高技能的实验室工作人员。EUROPattern Cosmic IFA系统（EUROIMMUN，Cosmic公司）和HELIOS*（Aesku Diagnostics，MBL）是用于ANA检测的计算机辅助显微镜系统，在对每个系统的不同人群进行测量时，与传统方法相比，其阳性率的一致性分别高达93.3%和91.9%，抗体滴度的一致性分别高达94.0%和98.8%（在±1个滴度范围内）。尽管计算机辅助显微镜系统不被认为是一个完整的系统，实验室工作人员应核实每个结果，但它对于常规ANA分析是一个有用的系统，因为它有助于ANA标准化和提高工作流程效率。在我们之前的研究中，我们证明了使用悬浮微珠阵列技术的全自动免疫分析分析仪BioPlex2200（Bio-Rad）对自身免疫性疾病的临床诊断有用。作为ANA筛查试验，健康受试者的阳性率较低（7.2%），与IFA（X160）相当。除系统性红斑狼疮中的抗双链DNA抗体外，结缔组织病患者中疾病特异性ANA的患病率与总体发生率相当。根据传统方法的双向免疫扩散和免疫印迹结果，除抗双链DNA抗体外，BioPlex2200与传统方法之间的一致性率较高（95.0 - 100%）。为了在考虑工作效率和降低成本的同时提供高质量和及时的临床检测，每个实验室应积极创新并应用这些先进的检测技术。[综述]
