Clinical Performance of Two Automated Immunoassays, EliA CTD Screen and QUANTA Flash CTD Screen Plus, for Antinuclear Antibody Screening
2022; 42(1): 63-70
Ann Lab Med 2017; 37(3): 240-247
Published online May 1, 2017 https://doi.org/10.3343/alm.2017.37.3.240
Copyright © Korean Society for Laboratory Medicine.
In Young Yoo, M.D.1, Jong Won Oh, M.D.1, Hoon-Suk Cha, M.D.2, Eun-Mi Koh, M.D.2, and Eun-Suk Kang, M.D.1
Departments of Laboratory Medicine & Genetics1 and Internal Medicine2, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Correspondence to: Eun-Suk Kang
Department of Laboratory Medicine & Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background: 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.
Methods: 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.
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.
Conclusions: 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.
Keywords: Antinuclear antibody, Indirect immunofluorescence assay, Automated image analyzer, Pattern recognition