Ann Lab Med 2019; 39(3): 291-298  https://doi.org/10.3343/alm.2019.39.3.291
Detection of Autoantibodies Against Nucleoporin p62 in Sera of Patients With Primary Biliary Cholangitis
Alicja Bauer , Ph.D.1 and Andrzej Habior, M.D.2
1Departments of Biochemistry and Molecular Biology and 2Gastroenterology, Hepatology and Clinical Oncology, Centre of Postgraduate Medical Education, Warsaw, Poland
Corresponding author: Alicja Bauer, Ph.D. https://orcid.org/0000-0003-2051-1177
Department of Clinical Biochemistry and Molecular Biology, Centre of Postgraduate Medical Education, Ul. Marymoncka 99/103, 01-813, Warsaw, Poland
Tel: +48-22-5693815
Fax: +48-22-693712
E-mail: alabauer@wp.pl
Received: February 6, 2018; Revised: June 7, 2018; Accepted: November 7, 2018; Published online: May 1, 2019.
© Korean Society for Laboratory Medicine. All rights reserved.

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.
Abstract
Background: Primary biliary cholangitis (PBC) is an autoimmune liver disease characterized by specific autoantibodies. We evaluated the prevalence of autoantibodies against nucleoporin p62 (anti-p62) in PBC patients’ sera to determine whether it can be a marker for PBC, in comparison with other immunological and biochemical parameters. We validated the performance of our in-house ELISA technique.
Methods: Serum samples were collected from 135 PBC patients. Thirty patients with primary sclerosing cholangitis (PSC) and 30 with autoimmune hepatitis (AIH) were included as pathological controls, and 40 healthy blood donors served as healthy controls. The presence of anti-p62 was determined by an in-house ELISA using a recombinant protein. We calculated the sensitivity, specificity, positive and negative predictive values (PPV and NPV), and positive and negative likelihood ratio (LR+ and LR-) of our in-house ELISA for diagnosing PBC based on anti-p62. Findings were correlated with biochemical data and survival.
Results: Anti-p62 was detected in 32 PBC patients (23.7%). Specificity and PPV of anti-p62 for PBC were 99% and 97%, respectively. The difference between proportions of anti-p62-positive patients and controls was 0.23 (95% confidence interval [CI]: 0.03–0.40; P<0.0001); LR+ and LR- were 23.7 and 0.77, respectively. The presence of anti-p62 was associated with higher levels of bilirubin and alkaline phosphatase (P<0.001). The odds ratio for survival was 2.44 (95% CI: 0.87–6.87; P=0.091).
Conclusions: Anti-p62 may be regarded as a significant serological marker of PBC.
Keywords: Nucleoporin p62, Primary biliary cholangitis, ELISA, Autoantibodies, Liver, Recombinant protein



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