Assay for Hepatitis B Surface Antigen

A new assay for hepatitis B virus (HBV) surface antigen, HBsAg, is designed to be used with the Vitros Eci Immunodiagnostic system. The assay may also be used to screen for hepatitis B infection in pregnant women to identify neonates who are at high risk of acquiring HBV during the perinatal period.

The new assay utilizes serum or plasma, with results available in as little as 37 minutes. According to the standards established for the National Immunization Program by the U.S. Centers for Disease Control (Atlanta, GA, USA), administration of hepatitis B immune globulin and hepatitis B vaccine to the newborn should occur within 12 hours of birth if the mother tests positive for HbsAg. If the HbsAg status of the mother is unknown, the infant should receive HBV vaccine within 12 hours of birth. Thus, the ability to rapidly provide HbsAg tests results to be used in evaluating the mother's HBV status will help doctors care properly for newborns.

The test is the product of Ortho-Clinical Diagnostics (Raritan, NJ, USA) and has been cleared by the U.S. Food and Drug Administration (FDA). "Time to results is dramatically reduced with the Vitros HbsAg assay, and this test eliminates the need for batch testing, which provides significant efficiencies for the clinical laboratory,” noted Michael DeLucia, product director of infectious diseases, Ortho-Clinical Diagnostics.




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