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Original Article
Agreement of three commercial anti-extractable nuclear antigen tests: EUROASSAY Anti-ENA Profile, Polycheck Autoimmune Test and FIDIS Connective Profile - Namhee Kim1,2, In-Suk Kim1,2, Chulhun L Chang1,2, Hyung-Hoi Kim1,3, Eun Yup Lee1,3
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Kosin Medical Journal 2018;33(3):307-317.
DOI: https://doi.org/10.7180/kmj.2018.33.3.307
Published online: January 19, 2018
1Department of Laboratory Medicine, School of Medicine, Pusan National University, Busan, Korea
2Department of Laboratory Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea
3Department of Laboratory Medicine, Pusan National University Hospital, Busan, Korea
- Corresponding Author: In-Suk Kim, Department of Laboratory Medicine, Pusan National University Yangsan Hospital, Geumo-ro, 50612 Mulgeum-eup, Yangsan-si, Korea Tel: +82-55-360-1870 Fax: +82-55-360-1880 E-mail: iskim0710@gmail.com
• Received: December 16, 2015 • Revised: October 5, 2016 • Accepted: October 20, 2016
Copyright © 2018 Kosin University School of Medicine Proceedings
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.
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Abstract
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Background
- Detection of antibodies to extractable nuclear antigens (ENAs) is needed for the diagnosis in systemic autoimmune diseases. In this study, we compared three reagents using line immunoblot assay (LIA) or multiplex bead immunoassay for detecting the anti-ENAs.
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Methods
- A total of 89 sera were tested by 3 different assays: EUROASSAY Anti-ENA Profile (Euroimmune, Germany), Polycheck Autoimmune Test (Biocheck GmbH, Germany), and FIDIS™ Connective Profile (Biomedical Diagnostics, France). The following individual ENAs were investigated: Sm, SS-A (Ro), SS-B (La), Scl-70, Jo-1 and RNP. We reviewed medical records to investigate the discrepant results among three methods.
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Results
- Overall percent agreements were 96.1% between EUROASSAY Anti-ENA Profile and FIDIS™ Connective profile; 90.4% between EUROASSAY Anti-ENA Profile and Polycheck Autoimmune Test using the manufacturers’ cutoff; 96.4% between EUROASSAY Anti-ENA Profile and Polycheck Autoimmune Test using a upward cutoff; 90.4% between FIDIS™ Connective profile and Polycheck Autoimmune Test the manufacturers’ cutoff; and 96.4% between FIDIS™ Connective profile and Polycheck Autoimmune Test a upward cutoff.
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Conclusions
- The three assays showed excellent agreement with each other. With appropriate cutoff, the all three assays for six of the anti-ENA tests investigated in this study can be used in clinical laboratories for detecting the anti-ENAs.
Table 1.Comparison of the results for antibodies to extractable nuclear antigens by EUROASSAY Anti-ENA Profile and Polycheck Autoimmune Test (N = 89)
Table 2.Comparison of the results for antibodies to extractable nuclear antigens by EUROASSAY Anti-ENA Profile and FIDIS Connective Profile (N = 89)
Table 3.Comparison of the results for antibodies to extractable nuclear antigens by Polycheck Autoimmune Test FIDIS Connective Profile (N = 89)
Table 4.Comparison of the results for antibodies to extractable nuclear antigens by EUROASSAY Anti-ENA Profile and FIDIS Connective profile in the systemic autoimmune disorder (n = 33).
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