Overcoming a “Probable” Diagnosis in Antimitochondrial Antibody Negative Primary Biliary Cirrhosis: Study of 100 Sera and Review of the Literature

Bizzaro, Nicola; Covini, Giovanni; Rosina, Floriano; Muratori, Paolo; Tonutti, Elio; Villalta, Danilo; Pesente, Fiorenza; Alessio, Maria Grazia; Tampoia, Marilina; Antico, Antonio; Platzgummer, Stefan; Porcelli, Brunetta; Terzuoli, Lucia; Liguori, Marco; Bassetti, Danila; Brusca, Ignazio; Almasio, Piero L.; Tarantino, Giuseppe; Bonaguri, Chiara; Agostinis, Paolo; Bredi, Elena; Tozzoli, Renato; Invernizzi, Pietro; Selmi, Carlo

doi:10.1007/s12016-010-8234-y

Cited by 79Liver Diseases and ImmunityPediatric Hepatobiliary Diseases and TreatmentsIgG4-Related and Inflammatory Diseases

Overcoming a “Probable” Diagnosis in Antimitochondrial Antibody Negative Primary Biliary Cirrhosis: Study of 100 Sera and Review of the Literature

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Bizzaro, Nicola, Covini, Giovanni, Rosina, Floriano, Muratori, Paolo, Tonutti, Elio, Villalta, Danilo, Pesente, Fiorenza, Alessio, Maria Grazia +16 more·2012·Clinical Reviews in Allergy & Immunology

DOI 10.1007/s12016-010-8234-y

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Abstract

Serum anti-mitochondrial antibodies (AMA) are the serological hallmark of primary biliary cirrhosis (PBC), yet up to 15% of PBC sera are AMA negative at routine indirect immunofluorescence (IIF) while being referred to as "probable" cases. The diagnostic role of PBC-specific antinuclear antibodies (ANA) remains to be determined. We will report herein data on the accuracy of new laboratory tools for AMA and PBC-specific ANA in a large series of PBC sera that were AMA-negative at IIF. We will also provide a discussion of the history and current status of AMA detection methods. We included IIF AMA-negative PBC sera (n=100) and sera from patients with other chronic liver diseases (n=104) that had been independently tested for IIF AMA and ANA; sera were blindly tested with an ELISA PBC screening test including two ANA (gp210, sp100) and a triple (pMIT3) AMA recombinant antigens. Among IIF AMA-negative sera, 43/100 (43%) manifested reactivity using the PBC screening test. The same test was positive for 6/104 (5.8%) control sera. IIF AMA-negative/PBC screen-positive sera reacted against pMIT3 (11/43), gp210 (8/43), Sp100 (17/43), both pMIT3 and gp210 (1/43), or both pMIT3 and Sp100 (6/43). Concordance rates between the ANA pattern on HEp-2 cells and specific Sp100 and gp210 ELISA results in AMA-negative subjects were 92% for nuclear dots and Sp100 and 99% for nuclear rim and gp210. Our data confirm the hypothesis that a substantial part of IIF AMA-negative (formerly coined "probable") PBC cases manifest disease-specific autoantibodies when tested using newly available tools and thus overcome the previously suggested diagnostic classification. As suggested by the recent literature, we are convinced that the proportion of AMA-negative PBC cases will be significantly minimized by the use of new laboratory methods and recombinant antigens.

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The majority of AMA-negative patients will be positive for PBC-specific nuclear antibodies.
“The majority of these patients will be positive for the PBC-specific nuclear antibodies.265”
From The British Society of Gastroenterology/UK-PBC primary biliary cholangitis treatment and management guidelines (2018) · cites this paper as [265]
The indexed study summary (no page supplied) reports that 43 of 100 AMA-negative PBC sera reacted to a screening test that included both nuclear and mitochondrial antigens. Its antigen-specific results show PBC-specific nuclear-antibody reactivity in 32 of 100 sera, not a majority. (LLM, conf=0.88)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measured
Indirect immunofluorescence has the lowest sensitivity for AMA detection, with over 15% of AMA-negative sera by this method showing reactivity to MIT3.
“The indirect immunofluorescence method has the lowest sensitivity, with over 15% of AMA-negative sera by indirect immunofluorescence showing reactivity to MIT3, a combination of three mitochondrial antigens.(87)”
From Primary Biliary Cholangitis: 2018 Practice Guidance from the American Association for the Study of Liver Diseases (2019) · cites this paper as [87]
The indexed copy contains an IRIS repository listing and a PDF link, but no passage from the paper addressing assay sensitivity. Searches for MIT3, indirect immunofluorescence, and the claimed 15% figure found no relevant passage, so the claim cannot be checked against our copy. (LLM, conf=0.76)
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Role of autoimmunity in primary biliary cirrhosis
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Analysis of Autoantibodies against Promyelocytic Leukemia Nuclear Body Components and Biochemical Parameters in Sera of Patients with Primary Biliary Cholangitis
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Detection of Anti-kelch-like 12 and Anti-hexokinase 1 Antibodies in Primary Biliary Cholangitis Patients in China
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Less Travelled Roads in Clinical Immunology and Allergy: Drug Reactions and the Environmental Influence
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Presence of anti-gp210 or anti-sp100 antibodies in AMA-positive patients may help support a diagnosis of primary biliary cholangitis
Jaskowski, T. D., Nandakumar, V., Novis, C. L., Palmer, M., & Tebo, A. E. (2023) · Clinica Chimica Acta · doi:10.1016/j.cca.2023.117219 · Cited by 8 · see citing works
Cutting-edge Issues in Autoimmunity and Allergy of the Digestive System
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Diagnosis and Treatment of Autoimmune Liver Diseases in a Tertiary Referral Center in Cuba
Castellanos, M., Hernández, D. L. R., Eugenio, D., Palanca, W., Guridi, Z. D., & Fabián, L. G. (2017) · Current Therapeutic Research · doi:10.1016/j.curtheres.2017.04.002 · Cited by 8 · see citing works
Anti‐gp210 and anti‐centromere antibodies for the prediction of PBC patients with an incomplete biochemical response to UDCA and bezafibrate
Honda, A., Ikegami, T., & Matsuzaki, Y. (2015) · Hepatology Research · doi:10.1111/hepr.12461 · Cited by 8 · see citing works
Clinical impact of antibodies to Sp100 on a bacterial infection in patients with primary biliary cholangitis
Himoto, T., Yamamoto, S., Morimoto, K., Tada, S., Mimura, S., Fujita, K., Tani, J., Morishita, A., & Masaki, T. (2021) · Journal of Clinical Laboratory Analysis · doi:10.1002/jcla.24040 · Cited by 7 · see citing works
Tuberculosis Is Not a Risk Factor for Primary Biliary Cirrhosis: A Review of the Literature
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Diagnostic accuracy of two tests for determination of anti-m2 in the diagnosis of primary biliary cirrhosis: Is it possible to predict the course of the disease?
Alfano, A., Romito, A., Marchese, C., Battistini, M., Crotti, G., Ferrini, A., Mancinetti, C., Manetta, T., Mengozzi, G., Merlach, P., et al. (2016) · Immunologic research · doi:10.1007/s12026-016-8838-2 · Cited by 6 · see citing works
Optimization of Laboratory Diagnostics of Primary Biliary Cholangitis: When Solid-Phase Assays and Immunofluorescence Combine
Gaiani, F., Minerba, R., Picanza, A., Russo, A., Melegari, A., Santis, E. D., Trenti, T., Belloni, L., Peveri, S., Aloe, R., et al. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11175238 · Cited by 5 · see citing works
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The evolving potential of precision medicine in the management of autoimmune liver disease
Norman, G. L., Bizzaro, N., Villalta, D., Vergani, D., Mieli‐Vergani, G., Hirschfield, G. M., & Mähler, M. (2021) · Elsevier eBooks · doi:10.1016/b978-0-12-820239-5.00012-7 · Cited by 5 · see citing works
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Clinical significance of IgG antimitochondrial M2 antibody levels in primary biliary cholangitis: A single center study from China
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Association of solid-phase assays to the indirect immunofluorescence in primary biliary cholangitis diagnosis: Results of an Italian multicenter study
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Sorrentino, M. C., SIPMeL, A. N. D. G.-A., Carbone, T., Cinquanta, L., Alessio, M. G., Infantino, M. G., Deleonardi, G., TREVISAN, M. T., Porcelli, B., Terzuoli, L., et al. (2024) · La Rivista Italiana della Medicina di Laboratorio - Italian Journal of Laboratory Medicine · doi:10.23736/s1825-859x.24.00226-3 · Cited by 2 · see citing works
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Determinazione di profili autoanticorpali con metodi multiparametrici proteomici: impatto su prevenzione, diagnosi, monitoraggio e terapia personalizzata nelle malattie autoimmuni
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Italian Society of Clinical Pathology and Laboratory Medicine (SIPMeL) guidelines on the use of autoantibody tests in the diagnosis of autoimmune liver diseases
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Primary Biliary Cholangitis: Its Science and Practice
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Diagnostic Liver Immunology
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Serologische Fallstricke in der Diagnostik einer unklaren Hepatopathie
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Overlap Syndromes of Primary Sclerosing Cholangitis
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25 anni di attività del Gruppo di Studio SIPMeL in Autoimmunologia: un percorso tra formazione e ricerca scientifica
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A woman with anti-mitochondrial antibody-negative primary biliary cholangitis for a long-term intermittent elevated hepatic enzymes: a case report
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Autoantibodies in Primary Biliary Cirrhosis
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Novel Antibodies for Anti-Mitochondrial Antibody-Negative Primary Biliary Cholangitis
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The erosion of seronegative autoimmune diseases through the lens of autoantibodies
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AGA/AASLD Clinical Practice Guideline on Management of Primary Biliary Cholangitis
Levy, C., Mayo, M. J., Carey, E. J., Chen, V. L., Assis, D. N., Goel, A., Sedki, M., Sultan, S., Taddei, T., Bittermann, T., et al. (2026) · Gastroenterology · doi:10.1053/j.gastro.2026.08.025
AASLD AGA clinical Practice Guideline on management of primary biliary cholangitis
Levy, C., Mayo, M. J., Carey, E. J., Chen, V. L., Assis, D. N., Goel, A., Sedki, M., Sultan, S., Taddei, T. H., Bittermann, T., et al. (2026) · Hepatology · doi:10.1097/hep.0000000000001875

The diagnostic value of anti-mitochondrial antibodies, especially in primary biliary cirrhosis.
Tanaka, A., Miyakawa, H., Luketic, V. A., Kaplan, M., Storch, W., & Gershwin, M. E. (2002) · PubMed · Cited by 21 · see citing works
S72 Diagnostic Value of Anti-Mitochondrial Antibodies (AMA), Anti-M2, Anti-sp100, and Anti-gp210 in Primary Biliary Cholangitis (PBC)
Yang, J., Aikins, A. O., Punzalan, R., Alfego, D., & Chun, K. (2024) · The American Journal of Gastroenterology · doi:10.14309/01.ajg.0001028656.80979.24
Value of serum autoantibodies in the diagnosis of anti-mitochondrial antibody-negative primary biliary cirrhosis
Luo, L., Zhou, L., Zhang, J., & Jiao, G. (2015) · Zhonghua xiaohua zazhi · doi:10.3760/cma.j.issn.0254-1432.2015.02.004
Antimitochondrial Antibodies and Other Antibodies in Primary Biliary Cirrhosis: Diagnostic and Prognostic Value
Muratori, L., Granito, A., Muratori, P., Παππάς, Γ., & Bianchi, F. B. (2008) · Clinics in Liver Disease · doi:10.1016/j.cld.2008.02.009 · Cited by 87 · see citing works
Self-citation
‘True’ antimitochondrial antibody-negative primary biliary cirrhosis, low sensitivity of the routine assays, or both?
Muratori, P., Muratori, L., Gershwin, M. E., Czaja, A. J., Παππάς, Γ., Maccariello, S., Granito, A., Cassani, F., Loria, P., Lenzi, M., et al. (2003) · Clinical & Experimental Immunology · doi:10.1111/j.1365-2249.2004.02332.x · Cited by 84 · see citing works
Self-citation

Authors: Bizzaro, N., Covini, G., Rosina, F., Muratori, P., Tonutti, E., Villalta, D., Pesente, F., Alessio, M. G., Tampoia, M., Antico, A., Platzgummer, S., Porcelli, B., Terzuoli, L., Liguori, M., Bassetti, D., Brusca, I., Almasio, P. L., Tarantino, G., Bonaguri, C., Agostinis, P., Bredi, E., Tozzoli, R., Invernizzi, P., & Selmi, C.
Affiliations: IRCCS Humanitas Research Hospital (IT)
IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT)
University of Udine (IT)
Azienda Ospedaliera Santa Maria Degli Angeli (IT)
Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari (IT)
Krankenhaus Meran (IT)
University of Siena (IT)
Azienda Ospedaliera G. Brotzu (IT)
Ospedale Santa Chiara (IT)
Ospedale Buccheri la Ferla Fatebenefratelli (IT)
University of Palermo (IT)
Ospedale di Parma (IT)
Ospedale di Latisana (IT)
University of Milan (IT)
Corresponding author: Bizzaro, Nicola
ORCID: Bizzaro, Nicola
Covini, Giovanni
Muratori, Paolo
Villalta, Danilo
Alessio, Maria Grazia
Tampoia, Marilina
Antico, Antonio
Porcelli, Brunetta
Terzuoli, Lucia
Brusca, Ignazio
Almasio, Piero L.
Tarantino, Giuseppe
Bonaguri, Chiara
Agostinis, Paolo
Tozzoli, Renato
Invernizzi, Pietro
Selmi, Carlo
Venue: Clinical Reviews in Allergy & Immunology
Publisher: Springer Science and Business Media LLC
Published: 2010-12-29
Volume: 42
Issue: 3
Pages: 288-297
ISSN: 1080-0549 (ISSN-L)
1559-0267
DOI: 10.1007/s12016-010-8234-y
OpenAlex: W1984613038
Cited by: 79
References: 74
Citations by year: 2026: 6 · 2024: 2 · 2023: 9 · 2022: 3 · 2021: 7 · 2020: 8 · 2019: 3 · 2018: 5 · 2017: 4 · 2016: 7 · 2015: 4 · 2014: 6 · 2013: 5 · 2012: 9
FWCI: 0.66
Type: journal article
Language: en
Open access: green
hdl.handle.net
Licence: other-oa
www.springer.com/tdm (tdm)
Locations: Clinical Reviews in Allergy & Immunology (publishedVersion)
PubMed (publishedVersion)
Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
Nova Science Publishers (Nova Science Publishers, Inc.) (submittedVersion, other-oa)
Use Siena air (University of Siena) (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, antimitochondrial antibodies, gp210, SP-100, indirect immunofluorescence, autoantibody diagnosis, chronic liver disease, diagnostic accuracy
MeSH terms: Adult, Aged, Aged, 80 and over, Autoantibodies, Female, Humans, Liver Cirrhosis, Biliary, Male, Middle Aged, Mitochondria

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Overcoming a “Probable” Diagnosis in Antimitochondrial Antibody Negative Primary Biliary Cirrhosis: Study of 100 Sera and Review of the Literature

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