Shovman O, Agmon-Levin N, Gilburd B, Martins T, Petzold A, Matthias T, Shoenfeld Y
Zabludowitz Center for Autoimmune Diseases Sheba Medical Center, 52621, Tel Hashomer, Israel.
Immunol Res. 2015 Feb;61(1-2):135-40. doi: 10.1007/s12026-014-8588-y.
Indirect immunofluorescence (IIF) is the main technique for the detection of antinuclear antibodies (ANA) and antineutrophil cytoplasmic antibodies (ANCA). The fully automated IIF processor HELIOS(®) is the first IIF processor that is able to automatically prepare slides and perform automatic reading. The objective of the present study was to determine the diagnostic performance of this system for ANA and ANCA IIF interpretation, in comparison with visual IIF. ANA detection by visual IIF or HELIOS(®) was performed on 425 sera samples including: 218 consecutive samples submitted to a reference laboratory for routine ANA testing, 137 samples from healthy subjects and 70 ANA/ENA positive samples. For ANCA determination, 170 sera samples were collected: 40 samples for routine testing, 90 samples from healthy blood donors and 40 anti-PR3/anti-MPO positive subjects. Good correlation was found for the visual and automated ANA IIF approach regarding positive/negative discrimination of these samples (kappa = 0.633 for ANA positive samples and kappa = 0.657 for ANA negative samples, respectively). Positive/negative IIF ANCA discrimination by HELIOS(®) and visual IIF revealed a complete agreement of 100% in sera from healthy patients and PR3/MPO positive samples (kappa = 1.00). There was 95% agreement between the ANCA IIF performed by automated and visual IIF on the investigation of routine samples. Based on these results, HELIOS(®) demonstrated a high diagnostic performance for the automated ANA and ANCA IIF interpretation that was similar to a visual reading in all groups of samples.
间接免疫荧光法（IIF）是检测抗核抗体（ANA）和抗中性粒细胞胞浆抗体（ANCA）的主要技术。全自动IIF处理器HELIOS(®)是首个能够自动制备载玻片并进行自动判读的IIF处理器。本研究的目的是与目视IIF相比，确定该系统对ANA和ANCA IIF判读的诊断性能。通过目视IIF或HELIOS(®)对425份血清样本进行ANA检测，这些样本包括：218份连续提交至参考实验室进行常规ANA检测的样本、137份来自健康受试者的样本以及70份ANA/ENA阳性样本。对于ANCA检测，收集了170份血清样本：40份用于常规检测的样本、90份来自健康献血者的样本以及40份抗PR3/抗MPO阳性受试者的样本。在这些样本的阳性/阴性鉴别方面，目视和自动化ANA IIF方法具有良好的相关性（ANA阳性样本的kappa值分别为0.633，ANA阴性样本的kappa值分别为0.657）。HELIOS(®)和目视IIF对IIF ANCA的阳性/阴性鉴别显示，健康患者血清和PR3/MPO阳性样本的完全一致性为100%（kappa = 1.00）。在常规样本检测中，自动化和目视IIF进行的ANCA IIF之间有95%的一致性。基于这些结果，HELIOS(®)在自动化ANA和ANCA IIF判读方面表现出较高的诊断性能，在所有样本组中与目视判读相似。
