Sensitivity of the test for antibody to hepatitis B surface antigen--United States.
Beginning in March 1986, some test kits for antibody to hepatitis B surface antigen (anti-HBs) were modified to increase sensitivity, and new anti-HBs tests were introduced with increased sensitivity for detecting anti-HBs. To assess the impact of this increased sensitivity on the interpretation of hepatitis B postvaccination testing results, the Food and Drug Administration (FDA) conducted a study of currently distributed anti-HBs test kits to determine the lower limits of their sensitivity relative to the World Health Organization (WHO) Anti-HBs Reference Preparation. In addition, CDC conducted a study among a group of vaccinated public safety workers to determine the positive predictive values of the current anti-HBs tests when used to evaluate immunity after hepatitis B vaccination. This report provides background to and summarizes the results of these two studies.
D006510:Hepatitis B Antibodies / Q000097:blood*; D006514:Hepatitis B Surface Antigens / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques; D011863:Radioimmunoassay; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D014481:United States
D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D011933:Reagent Kits, Diagnostic