Yoo In Young, Oh Jong Won, Cha Hoon Suk, Koh Eun Mi, Kang Eun Suk
Department of Laboratory Medicine & Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Ann Lab Med. 2017 May;37(3):240-247. doi: 10.3343/alm.2017.37.3.240.
The gold standard for antinuclear antibody (ANA) screening is the indirect immunofluorescence (IIF) assay with human epithelial cells (HEp-2). However, a number of substantial disadvantages of manual IIF assays have highlighted the need for the automation and standardization of fluorescent ANA (FANA) testing. We evaluated the performance of EUROPattern Suite (Euroimmun AG, Germany), an automated FANA image analyzer, with regard to ANA detection and pattern recognition compared with conventional manual interpretation using the fluorescence microscopic IIF assay.
A total of 104 samples including 70 ANA-positive sera and 34 ANA-negative sera collected from September to October 2015 were included. The sensitivity, specificity, and pattern recognition function were evaluated to determine the performance of EUROPattern Suite compared with the manual IIF assay results.
The sensitivity and specificity of EUROPattern Suite for ANA detection were 94.3% and 94.1%, respectively. The concordance rate between the two methods was 94.2%. For pattern recognition, 45.7% of the samples were assigned identical ANA patterns including simple and mixed. When major pattern matching was considered, 83.7% (41/49) and 95.2% (20/21) of the samples with simple and mixed patterns, respectively, showed concordant results between the two methods.
EUROPattern Suite, an automated FANA image analyzer, provides a viable option for distinguishing between positive and negative results, although the ability to assign specific patterns is insufficient to replace manual microscopic interpretation. This automated system may increase efficiency in laboratories, in which a large number of samples need to be processed.
抗核抗体（ANA）筛查的金标准是用人上皮细胞（HEp-2）进行间接免疫荧光（IIF）检测。然而，手工IIF检测存在诸多显著缺点，这凸显了荧光ANA（FANA）检测自动化和标准化的必要性。我们评估了EUROPattern Suite（德国Euroimmun AG公司）这一自动化FANA图像分析仪在ANA检测和模式识别方面的性能，并与使用荧光显微镜IIF检测的传统手工判读进行比较。
纳入了2015年9月至10月收集的104份样本，其中包括70份ANA阳性血清和34份ANA阴性血清。评估了EUROPattern Suite的敏感性、特异性和模式识别功能，以确定其与手工IIF检测结果相比的性能。
EUROPattern Suite检测ANA的敏感性和特异性分别为94.3%和94.1%。两种方法的一致性率为94.2%。对于模式识别，45.7%的样本被指定了相同的ANA模式，包括单一模式和混合模式。当考虑主要模式匹配时，单一模式和混合模式的样本中，分别有83.7%（41/49）和95.2%（20/21）在两种方法之间显示出一致的结果。
EUROPattern Suite这一自动化FANA图像分析仪为区分阳性和阴性结果提供了一个可行的选择，尽管指定特定模式的能力不足以取代手工显微镜判读。这种自动化系统可能会提高需要处理大量样本的实验室的效率。
