Hepatitis B Virus and Hepatitis B Surface Antigen in Human Albumin Products

Abstract

A collection of 1985 lots of normal serum albumin (NSA) and 1361 lots of plasma protein fraction (PPF) prepared between 1958-1974 were tested for the presence of hepatitis B surface antigen (HBsAg). Radioimmunoassay revealed 21% of NSA lots and 71% PPF lots to be HBsAg-positive. There was considerable variation in frequency of HBsAg-positive lots among the 17 manufacturers of NSA and the 6 manufacturers of PPF. Generally those lots prepared from volunteer donor plasma and placental material demonstrated lower rates of HBsAg-positivity than those prepared from commercial donor plasma. A striking decrease in the prevalence of HBsAg-positive lots of NSA and PPF occurred during 1971-1973, coincident with the onset of routine screening of all plasma for HBsAg. Although NSA and PPF can be HBsAg-positive, they probably do not transmit type B hepatitis. Serologic tests for HBsAg and antibody to HBsAg revealed that albumin products prepared from infectious, icterogenic plasma were infectious prior to pasteurization, but that they no longer transmitted type B hepatitis after heat treatment at 60.degree. C for 10 h.