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Development of an enzyme immune assay for detecting M2 autoantibodies specific for primary biliary cirrhosis


   OBJECTIVE: To develope a new enzyme immune assay (ELISA) for detection of M2 antibody specificfor primary biliary cirrhosis (PBC) by using a triple hybrid clone as antigen, which coexpresses the threeimmunodominant lipoyl domains of PDC-E2, BCOADC-E2 and OGDC-E2 from human sources.METHODS: After expressing autoantigens of PBC in prokaryote by constructing recombinant expressiveplasmid successfully, the fusion protein was purified by affinity chromatography. The sera of 17 PBCpatients were examined. As controls, the sera of 167 non-PBC patients and the sera of 1225 normalcontrols aged under 28 were examined.RESULTS: None of the sera from the non-PBC patients or the normal controls was positive for anti-M2shown by the new ELISA. However, the positivity rate for anti-M2 in the PBC patients was 100%(17/17), as shown by the new ELISA.CONCLUSION: The detection system with a good sensitivity and specificity may be used as a powerfulmethod for the diagnosis of PBC.……