A Comparative Evaluation of the Performances of Anti-MIT3, Anti-gp210, and Anti-sp100 Antibodies for the Diagnosis of Primary Biliary Cirrhosis

Yun-A Jo; Mi Young Kim; Han-Sung Kim; Young Kyung Lee; Hee Jung Kang; Jong Hyeok Kim

doi:10.3343/lmo.2014.4.2.91

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Jo, Kim, Kim, Lee, Kang, and Kim: A Comparative Evaluation of the Performances of Anti-MIT3, Anti-gp210, and Anti-sp100 Antibodies for the Diagnosis of Primary Biliary Cirrhosis

Original Article

Diagnostic Immunology

Laboratory Medicine Online 2014; 4(2): 91-97.

Published online: 1 April 2014

DOI: https://doi.org/10.3343/lmo.2014.4.2.91

A Comparative Evaluation of the Performances of Anti-MIT3, Anti-gp210, and Anti-sp100 Antibodies for the Diagnosis of Primary Biliary Cirrhosis

Yun-A Jo, M.D.¹, Mi Young Kim, M.D.¹, Han-Sung Kim, M.D.¹, Young Kyung Lee, M.D.¹, Hee Jung Kang, M.D.¹, Jong Hyeok Kim, M.D.²

¹Department of Laboratory Medicine, Hallym University College of Medicine, Anyang, Korea.

²Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hallym University College of Medicine, Anyang, Korea.

Corresponding author: Hee Jung Kang. Department of Laboratory Medicine, Hallym University College of Medicine, 22 Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang 431-796, Korea. Tel: +82-31-380-3929, Fax: +82-31-380-3934, kangheejung@hallym.or.kr

Received 14 January 2013 Revised 1 August 2013 Accepted 20 August 2013

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

Anti-mitochondrial antibody (AMA) is a serological hallmark of primary biliary cirrhosis (PBC). AMAs are detected by an immunofluorescence assay (IF), which is subject to errors. We evaluated the diagnostic performances of the AMA ELISA test (the anti-MIT3 antibody) and PBC-associated antinuclear antibody (ANA) tests (the anti-gp210 and anti-sp100 antibodies).

Methods

AMA, anti-gp210, and anti-sp100 were measured in the sera of 130 subjects including patients for whom the AMA test was requested with the clinical suspicion of PBC, patients with other autoimmune diseases, and those undergoing health check-ups. AMA was detected by both IF and ELISA (anti-MIT3 antibodies), and anti-gp210 and anti-sp100 were detected by ELISA. The diagnostic performances of the anti-MIT3, anti-gp210, and anti-sp100 were compared with that of the AMA IF test. Associations between the presence of anti-sp100 or anti-gp210 and the diagnosis and biochemical abnormalities of PBC were investigated.

Results

The area under the curve of anti-MIT3 for the diagnosis of PBC was 0.934 (95% confidence interval, 0.877-0.970), and the agreement between anti-MIT3 and AMA IF was 93.8% (κ, 0.82). The sensitivities of anti-MIT3 and AMA IF were both 100%, and the specificities were 83.1% and 81.4%, respectively, whereas the sensitivities of anti-gp210 and anti-sp100 were 41.7% and 16.7%, and their specificities were 94.9% and 97.5%, respectively. The presence of anti-gp210 was associated with the diagnosis of PBC (P=0.0001), but that of anti-sp100 was not.

Conclusions

The diagnostic performance of anti-MIT3 is comparable to that of AMA IF. Anti-gp210 seems to be complementary to AMA for the diagnosis of PBC.

Keywords: anti-MIT3, AMA, PBC, anti-gp210, anti-sp100

Figures and Tables

Fig. 1

Receiver operating characteristics curve for anti-MIT3 in the patients with PBC. The area under the curve of the anti-MIT3 is 0.934. The arrow indicates optimum cut-off value.

Table 1

Diagnostic performance of AMA IF and anti-MIT3 for the patients with primary biliary cirrhosis (PBC)

Abbreviations: IF indirect immunofluorescence; PPV, positive predictive value; NPV, negative predictive value.

Table 2

Comparison of the results of AMA IF and anti-MIT3 with the sera of each group

Group 1, sera requested for AMA IF; Group 2, sera positive for AMA IF; Group 3, sera strongly positive for antinuclear antibody; Group 4, sera of subjects for health check-up.

Table 3

Clinical characteristics of patients showing discordant results in AMA IF and anti-MIT3 ELISA

Cut-off level: anti-MIT3, 76 units; anti-sp100, 25 units; anti-gp210, 25 units, reference range: total bilirubin, 0.2-1.2 mg/dL; direct bilirubin, 0-0.4 mg/dL; AST, 8-38 IU/L; ALT, 5-43 IU/L; ALP, alkaline phosphatase 80-241 IU/L; GGT, gamma-glutamyl transpeptidase 11-75 U/L.

Abbreviation: NT, not tested.

Table 4

Diagnostic performance of anti-gp210 and anti-sp100 antibodies for the patients with primary biliary cirrhosis (PBC)

Table 5

Clinical characteristics of patients having anti-gp210 antibody

Abbreviation: NT, not tested; PBC, primary biliary cirrhosis.

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