目的 比较新型研发的PBC筛查试剂盒与单个MIT3,以及2个抗核抗体(ANA)gp210和sp100 ELISA检测试剂盒在中国人群中PBC诊断的性能.方法 使用PBC screen ELISA筛查试剂盒和单独针对MIT3、gp210和sp100抗原的ELISA试剂盒,对95例确诊PBC患者、125例非PBC患者(自身免疫性肝炎/原发性硬化性胆管炎18例,病毒性肝炎32例,其他肝脏疾病21例),以及健康人54例的血清样本进行检测.结果 PBC Screen ELISA法检测敏感性为76.8%,特异性为95.2%.特异性与结合单独ELISA法检测MIT3、gp210和sp100抗体的特异性96.0%相当.在32例用间接免疫荧光(indirect immunofluorescence,IIF)检测为阴性的PBC患者中,有15(46.9%)例PBC Screen ELISA检测结果为阳性.结论 PBC Screen ELISA是理想的一线PBC筛查试剂,尤其对于IIF筛查为阴性的PBC患者展现出优良的评估性能.%Objective To Detect antibodies against mitochondrial and nuclear antigens for diagnosis of primary biliary cirrhosis (PBC) and to compare the performance of the PBC Screen to the combined performance obtained with individual IgG ELISAs to MIT3,gp210,and sp100 in the patients with PBC. Methods The PBC Screen and individual antibodies to MIT3,anti-gp210,and anti-sp100 were measured in sera of 220 individuals. Final diagnosis of PBC had been made in 95 of the participants and the rest included individuals with autoimmune hepatitis (AIH)/ primary sclerosing cholangitis (18 cases),viral hepatitis(32 cases),or other liver diseases (21 cases),and healthy controls(54 persons). Results The PBC Screen at the cutoff of 25 units had an overall sensitivity of 76.8%,specificity of 95.2%, similar to the specificity of 96.0% obtained by the combined results of individual MIT3,sp100,and gp210 IgG ELISAs. Of the 32 PBC patients without AMA detected by indirect immunofluorescence(IIF),15(46.9%) were positive for PBC-specific autoantibodies. Conclusions The PBC Screen is an ideal first-line test for the diagnosis of PBC,especially for those who showed negative IIF.
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