The Antibody to HBsAg ELISA Test System 3 is a qualitative third-generation enzyme-linked immunosorbent assay for the detection of hepatitis B surface antigen (HBsAg) in human serum or plasma. It is indicated as a screening test and an aid in diagnosis of potential hepatitis B infection.
     The risk of hepatitis B virus transmission by blood transfusion is at present higher than that of hepatitis C or HIV transmission. This assay provides improved sensitivity and specificity, as well as several enhancements for customers. The sensitivity is 0.10 ng/mL, with a specificity of 99.97%, based on clinical trial data. 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.
     This company has also received FDA approval for its Antibody to HBsAg ELISA Test System 3 confirmatory test, a third-generation assay used to confirm the presence of hepatitis B surface antigen in specimens found repeatedly reactive in its Antibody to HBsAg ELISA Test System 3. It utilizes a neutralization procedure in conjunction with the standard methodology of the Antibody to HBsAg ELISA Test System 3.
     These approvals strengthen the assay portfolio run on the Summit System, a fully automated system that performs all FDA-required screening tests and comprehensively documents the process.
Ortho-Clinical Diagnostics
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Keywords: infectious disease, hepatitis, blood banking