ELISA for Hepatitis B Surface Antigen

A qualitative third-generation enzyme-linked immunosorbent assay (ELISA) detects hepatitis B surface antigen (HbsAg) in human serum or plasma and is indicated as an aid in the diagnosis of potential hepatitis B infection.

The new assay, called HbsAg ELISA System 3, provides improved sensitivity (0.10 ng/ml) and specificity (99.97%). The newest feature of the assay is Sample Omission Monitoring (SOM). SOM is a qualitative color change technology that provides assurance that sample has been added. The assay runs on the Ortho Summit System, a fully automated system that performs all FDA-required screening tests and documents the process. A confirmatory test confirms the presence of hepatitis B surface antigen in specimens found repeatedly reactive in the ELISA Test System 3. Both tests have been cleared by the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research.

"The risk of hepatitis B virus transmission by blood transfusion is at present higher than that of hepatitis C or HIV transmission,” said David Ciavarella, M.D., executive director, clinical and medical affairs, Ortho-Clinical Diagnostics (Raritan, NJ, USA), which developed the assays. "Ortho HbsAg System 3 assay represents a significant advance in our ability to detect infectious units prior to transfusion.”





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