PREVALENCE OF HEPATITIS-B SURFACE-ANTIGEN IN COMMERCIALLY PREPARED PLASMA PRODUCTS

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  • 1 January 1976
    • journal article
    • research article
    • Vol. 88  (1) , 102-113
Abstract
Commercially available lots of plasma derivatives prepared between 1957-1975 were tested for hepatitis B surface antigen (HBsAg) by radioimmunoassay. In all, 69% of lots of plasma protein fraction, 40% of factor IX concentrate, 20% of normal serum albumin, 13% of antihemophilic factor, 3% of fibrinogen and 0.7% of immune serum globulin lots tested were HBsAg-positive. There was great variation in the prevalence of HBsAg-positive lots of each product among manufacturers, reflecting differences in methods of processing plasma, and differences in donor populations. Those manufacturers relying upon volunteer donor plasma or placental source material demonstrated lower rates of HBsAg-positive lots of final products than those relying upon commercial donor plasma. There was a marked decrease in the prevalence of positive lots during the period 1971-1973, coincident with the onset of routine plasma donor screening for HBsAg. Current requirements for plasma screening do not result in totally HBsAg-free plasma products. Use of more sensitive and more reliable tests for HBsAg will probably reduce contamination of plasma pools with HBsAg to undetectable levels. Despite HBsAg-status, the high-risk plasma products (fibrinogen, antihemophilic factor, factor IX concentrate) can transmit hepatitis and should be used only with the strictest indications.