Affiliations: *National Institute of Health, Department of Medical Sciences
**Faculty of Public Health, Mahidol University
Source: Thai Journal of Health Research 2000; 14(1): 19-26
Language: Thai with English abstract
One-step ELISA assay using monoclonal antibody for screening of Hepatitis B surface antigen (HBsAg) was developed in our laboratory and compared with commercial ELISA test kit. Monoclonal antibody raised against the common “a” determinant of HBsAg was established by fusion of myeloma cell line (P3-X63-Ag 8.653) with spleen cells of BALB/c mice immunized with plasma derived hepatitis B virus vaccine (adr subtype) and used as probe to develop the one-step ELISA assay. Four hundred forty seven human sera (245 HBsAg-positive and 202 HBsAg-negative), previously tested for the presence of HBsAg by Abbott diagnostics ELISA test kit, were used as the comparison samples between our one step ELISA and commercial ELISA test kit (Sanofi Pasteur). The results showed that 233 samples were positive by one-step ELISA and 245 samples were positive by commercial ELISA kit. The sensitivity specificity and accuracy of our test were 95.1%, 100% and 97.3%, respectively. While the positive and negative predictive values were 100% and 94.4%, respectively. Since the principle of our assay is based on monoclonal antibodies in a one-step assay, it gives advantages of time utilizing and simplicity over assays using heterologous antisera. This principle would also be applicable to a variety of antigen assay for which appropriate monoclonal antibodies are available.