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Clin Chim Acta. 2017 Jan;464:113-117. doi: 10.1016/j.cca.2016.11.021. Epub 2016 Nov 15.

Clinical relevance of combined anti-mitochondrial M2 detection assays for primary biliary cirrhosis.

Author information

1
Departments of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
2
Departments of Pathology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
3
Departments of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: ejoh@catholic.ac.kr.

Abstract

BACKGROUND:

Antimitochondrial antibody (AMA) is a specific serologic marker in primary biliary cirrhosis (PBC). The aim of this study was to evaluate the clinical relevance of combined AMA assays.

METHODS:

Sera were obtained from 79 patients with PBC and 108 patients with other liver disease. They were tested by indirect immunofluorescence (IIF) using rat kidney/stomach tissue and HEp2 cells as substrate, 4 AMA-M2 assays, anti-sp100, and anti-gp210 assays.

RESULTS:

Using IIF-AMA with cut-off titer of 1:40, the sensitivity and specificity for PBC were 88.6% and 87.0%, respectively. A cut-off titer of 1:80 improved the specificity to 93.5%. The 4 commercial assay kits using AMA-M2 autoantibodies showed sensitivity of 55.7-79.7% and specificity of 91.7-95.4% with moderate to good agreement. AMA-M2 assays using both native and recombinant E2 antigens had higher sensitivity. ANAs on HEp2 cells, anti-sp100, and anti-gp210 were detected in 67.1%, 13.9-15.2%, and 22.8-27.8% of PBC patients, respectively. Additional AMA-M2 specific assays in IIF-AMA negative and low titer positive (1:40) sera increased the sensitivity and specificity to 88.6% and 90.7%, respectively.

CONCLUSIONS:

Serological diagnosis for PBC using IIF with high titer cut-off and additional AMA-M2 specific tests by ELISA or LIA in IIF-negative sera should be used.

KEYWORDS:

Anti-mitochondrial antibody M2 subtype; Anti-mitochondrial autoantibodies; Combined test; Diagnosis; Primary biliary cirrhosis

PMID:
27864100
DOI:
10.1016/j.cca.2016.11.021
[Indexed for MEDLINE]

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