Immunologic Research

, Volume 65, Issue 1, pp 299–306 | Cite as

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?

  • Antonio Maria Alfano
  • Alessandra Romito
  • Cristiana Marchese
  • Marco Battistini
  • Giliola Crotti
  • Arturo Ferrini
  • Cristina Mancinetti
  • Tilde Manetta
  • Giulio Mengozzi
  • Paola Merlach
  • Marco Migliardi
  • Maria Teresa Tambuzzo
Mechanism in Autoimmunity


To evaluate the analytical agreement between results obtained from the indirect immunofluorescence methods and from the multiplexed line-blot assay and EliA-M2, to analyze the diagnostic accuracy in a cohort of primary biliary cirrhosis (PBC) patients and in control patients of two different types of tests for anti-M2 and assess whether, with the advent of a quantitative test, the possibility exists to correlate disease activity with the value of AMA. Serum analysis of 67 patients with fluorescence patterns detected on Hep-2 cells suggestive of PBC-related antibodies and three groups of patients (15 PBC, 16 PBC suspect and 48 disease controls) was carried out. All samples were tested by both a qualitative test multiplexed line-blot Autoimmune Liver Disease Profile Euroline and by a quantitative test EliA-M2 IgG. In order to evaluate a possible correlation between the quantitative M2 and disease activity, we divided patients mixed in a further three groups based on the value EliA-M2. For each of these groups were calculated the average values of the main indices of cholestasis. A perfect agreement was shown between the EliA-M2 and the multiplexed line-blot method for AMA detection. All sera of patients with PBC were positive with both tests, with a 100 % sensitivity. Forty-seven of the 48 sera of the control group were negative for both tests with a 100 % next specificity, and only 70 % for the AMA-IIF. We had also observed in the other three groups of patients that the average of the values of γ–glutamyl transpeptidase and alkaline phosphatase increases with the increase of the value EliA-M2. The difference between the mean values of the most significant parameter which the alkaline phosphatase of the three groups is significant, with a statistically significant difference between the first and the third group (p value 0.023). Both the qualitative method Profile Euroline and the quantitative EliA-M2 have a high diagnostic accuracy for PBC, with a specificity higher than the immunofluorescence method. These preliminary data might suggest the possibility of using the dosage EliA-M2 not only in the diagnosis phase but also in the monitoring of disease activity.


Primary biliary cirrhosis Anti-mitochondrial antibodies Antinuclear PBC-correlated antibodies Indirect immunofluorescence microscopy Solid phase methods Prognosis 



All the immunoassay kits used in this study were kindly supported by the manufacturers, namely Euroimmun, (Lübeck, Germany) and Phadia, Thermo Fisher Scientific (Uppsala, Sweden). The authors would like to thank Dr. Denis Cauchi Inglot for his essential support using the English language.

Compliance with ethical standards

Conflicts of interest

Antonio Maria Alfano, Alessandra Romito, Cristiana Marchese, Marco Battistini, Giliola Crotti, Arturo Ferrini, Cristina Mancinetti, Tilde Manetta, Giulio Mengozzi, Paola Merlach, Marco Migliardi and Maria Teresa Tambuzzo declare that they have no conflict of interest.


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Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  • Antonio Maria Alfano
    • 1
  • Alessandra Romito
    • 2
  • Cristiana Marchese
    • 3
  • Marco Battistini
    • 1
  • Giliola Crotti
    • 1
  • Arturo Ferrini
    • 1
  • Cristina Mancinetti
    • 1
  • Tilde Manetta
    • 4
  • Giulio Mengozzi
    • 4
  • Paola Merlach
    • 1
  • Marco Migliardi
    • 3
  • Maria Teresa Tambuzzo
    • 1
  1. 1.Clinical PathologyHospital ASL TO4CirièItaly
  2. 2.Analysis LaboratoryHospital Maria Vittoria ASL TO2TurinItaly
  3. 3.Analysis LaboratoryA.O. Ordine MaurizianoTurinItaly
  4. 4.Biochimical LaboratoryA.O.U. Città Della Salute E Della ScienzaTurinItaly

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