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PBC Screen: An IgG/IgA dual isotype ELISA detecting multiple mitochondrial and nuclear autoantibodies specific for primary biliary cirrhosis
Abstract
A dual isotype (IgG, IgA) enzyme-linked immunosorbent assay (ELISA) designed to provide enhanced detection of primary biliary cirrhosis (PBC)-specific autoantibodies against both major mitochondrial and nuclear antigens has been developed and recently become commercially available. The assay (PBC Screen) simultaneously detects IgG and IgA autoantibodies to the immunodominant portions of the 3 major mitochondrial (MIT3) and nuclear (gp210, and sp100) antigens. The aim of this study was to compare the performance of the PBC Screen to the combined performance obtained with individual IgG ELISAs to MIT3, gp210, and sp100 on a large group of selected patients from multiple centers. A total of 1175 patients with PBC and 1232 subjects without PBC were evaluated. Non-PBC groups included healthy controls (624) as well as individuals with autoimmune hepatitis (281), primary sclerosing cholangitis (77), viral hepatitis (91 hepatitis B and 98 hepatitis C), other liver diseases (31), and other infectious or autoimmune diseases (30). The PBC Screen at the receiver operator characteristic optimized cutoff of 27.8 units, had an overall sensitivity of 83.8%, specificity of 94.7% and area under curve of 0.9212. This was similar to the specificity of 96.1% obtained by the combined results of individual MIT3, sp100, and gp210 IgG ELISAs (kappa index at 0.898). Of the 253 PBC patients without AMA detectable by immunofluorescence, 113 (44.7%) were interpreted as positive for PBC-specific autoantibodies. In conclusion, the PBC Screen is an appropriate first-line test for the diagnosis of PBC, including for patients negative for markers assessed using conventional methods.
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“Approximately 5% of patients with PBC are negative for AMA (or anti PDC-E2/M2 by ELISA), although this figure in practice reflects the assays employed.263 264”
From The British Society of Gastroenterology/UK-PBC primary biliary cholangitis treatment and management guidelines (2018) · cites this paper as [264]
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Metadata
- Authors
- Liu, H., Norman, G. L., Shums, Z., Worman, H. J., Krawitt, E. L., Bizzaro, N., Vergani, D., Bogdanos, D. P., Dalekos, G. N., Milkiewicz, P., Czaja, A. J., Heathcote, E. J., Hirschfield, G. M., Tan, E. M., Miyachi, K., Bignotto, M., Battezzati, P. M., Lleo, A., Leung, P. S., Podda, M., Gershwin, M. E., & Invernizzi, P.
- Affiliations
- Guangzhou Women and Children Medical Center (CN)
- Columbia University Irving Medical Center (US)
- University of Vermont (US)
- King's College London (GB)
- Pomeranian Medical University (PL)
- Mayo Clinic (US)
- University of Toronto (CA)
- Scripps Research Institute (US)
- University of Milan (IT)
- University of California, Davis (US)
- Corresponding author
- Invernizzi, Pietro
- ORCID
- Venue
- Journal of Autoimmunity
- Publisher
- Elsevier BV
- Published
- 2010-12
- Volume
- 35
- Issue
- 4
- Pages
- 436-442
- ISSN
- 0896-8411 (ISSN-L)
- OpenAlex
- W1976817326
- Cited by
- 130
- References
- 46
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 2 · 2023: 11 · 2022: 7 · 2021: 5 · 2020: 7 · 2019: 8 · 2018: 4 · 2017: 9 · 2016: 6 · 2015: 5 · 2014: 8 · 2013: 14 · 2012: 23
- FWCI
- 11.34
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Autoimmunity (publishedVersion)
- PubMed (publishedVersion)
- University of Thessaly Institutional Repository (University of Thessaly) (submittedVersion)
- Research Portal (King's College London) (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
- Topics
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
- Health Sciences › Medicine › Rheumatology › IgG4-Related and Inflammatory Diseases
- Keywords
- primary biliary cirrhosis, autoantibody detection, sensitivity and specificity, autoimmune hepatitis, primary sclerosing cholangitis, hepatitis B, hepatitis C, serological diagnosis
- MeSH terms
- Autoantibodies, Autoantigens, Clinical Trials as Topic, Enzyme-Linked Immunosorbent Assay, Feasibility Studies, Humans, Immunoglobulin A, Immunoglobulin G, Liver Cirrhosis, Biliary, Recombinant Fusion Proteins, Sensitivity and Specificity, Reproducibility of Results, Likelihood Functions, Immunodominant Epitopes, Mitochondrial Proteins, Nuclear Pore Complex Proteins, Antigens, Nuclear
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