Automatic ELISA system for the detection of anti-mitochondrial M2 antibody and its clinical significance

doi:10.3969/j.issn.1673-8640.2015.12.017

Abstract

Abstract:

Objective To detect anti-mitochondrial M2 antibody by automatic enzyme-linked immunosorbent assay(ELISA) system and to investigate its clinical significance.Methods A total of 267 serum samples[(112 samples from patients with primary biliary cirrhosis (PBC), 77 samples from patients infected with hepatitis B virus (HBV)and 78 samples from healthy controls] were detected for anti-mitochondrial M2 antibody by automatic ELISA system. The precision and the clinical significance of detecting anti-mitochondrial M2 antibody were evaluated. Results The precision was good .The within-run and inter-day coefficients of variation(CV) were <5%. The patients with PBC had positive rate 89.3% (100/112) for anti-mitochondrial M2 antibody, usually in high levels (>800RU/mL, 63%, 71/112). The positive rate of anti-mitochondrial M2 antibody was 5.2%(4/77)in patients with HBV infection, including 3 cases of 25-100 RU/mL and 1 case of >100 RU/mL, and it was 5.1%(4/78)in healthy subjects. Conclusions Automatic ELISA system for the detection of anti-mitochondrial M2 antibody guarantees the stability of results. It will provide valuable laboratory reference for the diagnosis of PBC and the differential diagnosis for other liver diseases.

Key words: Anti-mitochondrial M2 antibody, Primary biliary cirrhosis, Enzyme-linked immunosorbent assay

CLC Number:

R446.61

ZHANG Haiping, YAN Huiping, ZHANG Xin, ZHAO Dantong, MA Yinxue, SUN Limei, LI Zhuomin.. Automatic ELISA system for the detection of anti-mitochondrial M2 antibody and its clinical significance[J]. Laboratory Medicine, 2015, 30(12): 1234-1237.

Figures/Tables 4

样本浓度	批内不精密度				天间不精密度
样本浓度	$x ?$ (RU/m L)	s	CV(%)		$x ?$ (RU/mL)	s	CV(%)
低值	39.82	0.53	1.33	42.34	0.91	2.15
高值	423.14	7.15	1.69	459.27	13.69	2.98

样本浓度	批内不精密度				天间不精密度
样本浓度	$x ?$ (RU/m L)	s	CV(%)		$x ?$ (RU/mL)	s	CV(%)
低值	39.82	0.53	1.33	42.34	0.91	2.15
高值	423.14	7.15	1.69	459.27	13.69	2.98

组别	例数	抗线粒体M2抗体
组别	例数	阳性数	阳性率(%)
PBC组	112	100	89.3
HBV感染组	77	4	5.2
健康对照组	78	4	5.1
合计	267	108	-

References 9

[1]	BOGDANOS DP, GERSHWIN ME.What is new in primary biliary cirrhosis[J]. Dig Dis, 2012, 30(Suppl 1): 20-31.
[2]	HIRSCHFIELD GM, GERSHWIN ME.The immunobiology and pathophysiology of primary biliary cirrhosis[J]. Annu Rev Pathol, 2013, 8:303-330.
[3]	LIASKOU E,HIRSCHFIELD GM, GERSHWIN ME.Mechanisms of tissue injury in autoimmune liver diseases[J]. Semin Immunopathol, 2014, 36(5): 553-568.
[4]	LINDOR KD, GERSHWIN ME, POUPON R, et al.Primary biliary cirrhosis[J]. Hepatology, 2009, 50(1) : 291-308.
[5]	中华医学会肝病学分会、中华医学会感染病学分会. 慢性乙型肝炎防治指南(2010年版)[J].中华肝脏病杂志,2011,19(1):13-24 .
[6]	谭延国,闫惠平,高祖华. 原发性胆汁性肝硬化中B细胞免疫的研究进展[J]. 临床肝胆病杂志, 2014, 30(5):400-404.
[7]	WANG L, WANG FS, CHANG C, et al.Breach of tolerance: primary biliary cirrhosis[J]. Semin Liver Dis, 2014, 34(3):297-317.
[8]	LI Y,WANG W, TANG L, et al.Chemokine(C-X-C m.png) ligand 13 promotes intrahepatic chemokine (C-X-C m.png) receptor 5+ lymphocyte homing and aberrant B-cell immune responses in primary biliary cirrhosis[J]. Hepatology, 2015, 61(6):1998-2007.
[9]	YANG Z, LIANG Y, QIN B, et al.Clinical significance of conventional serum autoantibodies for various liver diseases in a Chinese population[J]. Clin Biochem, 2012, 45(3): 203-206.

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