目的 建立检测人血清抗-延胡索酸水合酶(FH)的间接ELISA法,并评价其在自身免疫性肝炎(AIH)临床诊断中的价值.方法 采用FH蛋白建立血清抗-FH的间接ELISA法,并对反应条件进行优化.应用建立的ELISA法检测88例AIH、56例PBC、50例慢性乙型肝炎(CHB)、36例慢性丙型肝炎(CHC)和98例健康志愿者(HC)血清中的抗-FH.统计学方法采用χ^2检验和Kruskal-WallisH法.结果 建立了检测人血清抗-FH的间接ELISA法,并确定了反应条件.抗-FH的血清检测结果,在AIH患者中抗-FH的阳性率为40%,显著高于健康志愿者(3%,χ^2=38.44,P<0.01)、PBC组(7%,χ^2=18.45,P<0.01)、CHB组(2%,χ^2=23.59,P<0.01)和CHC组(6%,χ^2=14.29,P<0.01).抗-FH对AIH诊断的灵敏度为40%,特异度为94%.结论 采用ELISA法检测AIH血清中抗-FH可能提高AIH的诊断,该抗体可能是诊断AIH的新指标.
Objective To establish the enzyme-linked immunosorbent assay (ELISA) for detecting human serum fumarate hydratase (FH) antibody and evaluate its role in the diagnosis of autoantigen in autoimmune hepatitis (AIH).Methods The indirect ELISA was established using FH protein,and the reaction conditions were determined.Then,the anti-FH antibody were detected in the serum of 88 AIH patients,56 primary biliary cirrhosis (PBC) patients,50 chronic hepatitis B (HBV) patients,36 chronic hepatitis C (HCV) patients and 98 healthy controls(HC).The results were analyzed with chi-quare and Kruskal-Wallis H methods.Results The ELISA for detecting human anti-FH antibody was established successfully and the optimal reaction conditions were defined.The positive rate of anti-FH antibody in the AIH group (40%) was significantly higher than HC (3%,χ^2=38.44,P〈0.01),PBC group (7%,χ^2=18.45,P〈0.01),CHB group (2%,χ^2=23.59,P〈0.01) and CHC group (6%,χ^2=14.29,P〈0.01).Anti-FH antibody which was used to diagnose AIH revealed a sensitivity of 40% and specificity of 94%.Conclusion We have established the ELISA,which is used to detect human anti-FH antibody.It can be detected predominantly in AIH,and this implies that anti-FH antibody may be useful in improving the diagnosis of AIH.