DETECTION AND CHARACTERIZATION OF HEPATITIS-C VIRUS-RNA IN IMMUNE GLOBULINS

Background: Hepatitis C virus (HCV) RNA was measured in immune globuli ns and its chemical and physical properties were characterized. Study Design and Methods: The study examined 69 immune globulin lots from 7 manufacturers, including 44 intravenous and 25 intramuscular immune gl obulin preparations. In addition, 8 experimental intravenous immune gl obulin preparations were investigated. Detection and quantitation of H CV RNA were achieved by reverse transcription and nested polymerase ch ain reaction at limiting dilution. A multi-antigen anti-HCV enzyme imm unoassay was also used to test these immune globulins. Results: The hi ghest level of HCV RNA was found in an experimental immune globulin lo t derived from a plasma pool made up of 186 anti-c100-3-reactive units . HCV RNA was detected only in 1 of 7 manufacturers' experimental intr avenous immune globulin preparations derived from a pool made up of 28 87 anti-c100-3-negative units. It was also detected in commercial intr avenous immune globulin lots prepared by the same manufacturer from so urce plasma, but not from recovered plasma. More than half of the comm ercial intramuscular immune globulin lots, including specific immune g lobulin products, were HCV RNA positive. All immune globulin products examined were reactive for anti-HCV. Certain similarities were found f or HCV RNA present in an immune globulin product and plasma. Ethanol a t 20 or 25 percent had no effect upon the buoyant density of HCV RNA. Conclusion: Many immune globulin preparations contained HCV RNA, with levels depending upon both the type of starting plasma and the manufac turing process. Exposure to ethanol did not appear to affect the physi cal characteristics of HCV RNA.