Kosin Med J.  2018 Dec;33(3):307-317. 10.7180/kmj.2018.33.3.307.

Agreement of three commercial anti-extractable nuclear antigen tests: EUROASSAY Anti-ENA Profile, Polycheck Autoimmune Test and FID(IS) Connective Profile

• Kim N
• Kim IS
• Chang CL
• Kim HH
• Lee EY

• KMID: 2442541
• DOI: http://doi.org/10.7180/kmj.2018.33.3.307

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 FIDISâ„¢ 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 FIDISâ„¢ 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 FIDISâ„¢ Connective profile and Polycheck Autoimmune Test the manufacturers' cutoff; and 96.4% between FIDISâ„¢ 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.

Keyword

Anti-extractable nuclear antigen antibodies; Antinuclear antibodies; Autoimmunity

MeSH Terms

Antibodies
Antibodies, Antinuclear
Antigens, Nuclear
Autoimmune Diseases
Autoimmunity
Diagnosis
Immunoassay
Indicators and Reagents
Medical Records
Antibodies
Antibodies, Antinuclear
Antigens, Nuclear
Indicators and Reagents

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