Kosin Medical Journal (고신대학교 의과대학 학술지)

Kosin University College of Medicine (고신대학교 의과대학)
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Agreement of three commercial anti-extractable nuclear antigen tests: EUROASSAY Anti-ENA Profile, Polycheck Autoimmune Test and FIDIS Connective Profile

  • Kim, Namhee (Department of Laboratory Medicine, School of Medicine, Pusan National University) ;
  • Kim, In-Suk (Department of Laboratory Medicine, School of Medicine, Pusan National University) ;
  • Chang, Chulhun L (Department of Laboratory Medicine, School of Medicine, Pusan National University) ;
  • Kim, Hyung-Hoi (Department of Laboratory Medicine, School of Medicine, Pusan National University) ;
  • Lee, Eun Yup (Department of Laboratory Medicine, School of Medicine, Pusan National University)
  • Received : 2015.12.16
  • Accepted : 2016.10.20
  • Published : 2018.12.31
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Abstract

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. 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 $FIDIS^{TM}$ 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. Results: Overall percent agreements were 96.1% between EUROASSAY Anti-ENA Profile and $FIDIS^{TM}$ 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 $FIDIS^{TM}$ Connective profile and Polycheck Autoimmune Test the manufacturers' cutoff; and 96.4% between $FIDIS^{TM}$ Connective profile and Polycheck Autoimmune Test a upward cutoff. 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.

Keywords

Acknowledgement

Supported by : Busan University

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