Anti-Hepatitis B Surface Antigen Assay

An anti-hepatitis B surface antigen assay on a random-access system has received premarket approval by the U.S. Food and Drug Administration (FDA).

Called Vitros Anti-HBs assay, the test is for the qualitative in vitro determination of total antibody to hepatitis B surface antigen in human serum using the Vitros Eci immunodiagnostic system. This system is fully automated and uses enhanced chemiluminescence technology to provide high sensitivity, precision, and dynamic range.

Assay results may be used as an aid to determine susceptibility to the hepatitis B virus (HBV) infection for patients prior to or following HBV vaccination. A positive result is consistent with levels of anti-HBs greater than or equal to 10 mIU/ml. Assay results can aid doctors in advising patients if sufficient antibodies are present for protective immunity to HBV. This information is particularly important for high-risk individuals, says the developer, Ortho-Clinical Diagnostics, Inc. (Raritan, NJ, USA).

"A recent study conducted among health care workers who were vaccinated against hepatitis B showed no serologic evidence of immunity four to five years post vaccination,” said Dr. David Ciavarella, executive director, medical affairs, Ortho-Clinical Diagnostics.




Related Links:
Ortho-Clinical