A high-sensitivity quantitative ELISA detection system for the large HBV surface (LHBS) protein was developed. It includes monoclonal antibodies for LHBSchemiluminescent sandwich ELISA method. Clinical tests of the ELISA prodcuts have been performed in CHB cases. The LHBS detection methodsproducts have been filed for US provisional patentwill be submitted for the IVD approval.

1. In-house development of a series of high-sensitive-specific monoclonal antibodies for LHBS. 2. Establishment of the chemiluminescence quantitative HBV LHBS detection kit. 3. Clinical tests to examine clinical significancesapplicabilities of the HBV LHBS quantification kit,to evaluate LHBS as a novel biomarker in hepatitisHCC.

Early detection of the patient’s responses to anti-viral therapies can greatly benefit the decisionmodification of treatment plans. The LHBS chemiluminescence quantification ELISA kit products developed can be marketed in Taiwanother HBV epidemic countries such as Chinasome South East Asian countries. The products stand a good potential for high market value.