and characterization of hepatitis C virus RNA in immune globulins.
Yu MY, Mason BL, Tankersley DL
Transfusion 1994 Jul 34:7 596-602
Hepatitis C virus (HCV) RNA was measured in immune globulins 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 globulin preparations. In addition, 8 experimental
intravenous immune globulin preparations were investigated. Detection and
quantitation of HCV RNA were achieved by reverse transcription and nested
polymerase chain reaction at limiting dilution. A multi-antigen anti-HCV enzyme
immunoassay was also used to test these immune globulins.
RESULTS: The highest
level of HCV RNA was found in an experimental immune globulin lot 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 intravenous immune globulin preparations
derived from a pool made up of 2887 anti-c100-3-negative units. It was also
detected in commercial intravenous immune globulin lots prepared by the same
manufacturer from source plasma, but not from recovered plasma.
More than half
of the commercial intramuscular immune globulin lots, including specific immune
globulin products, were HCV RNA positive. All immune globulin products examined
were reactive for anti-HCV. Certain similarities were found for HCV RNA present
in an immune globulin product and plasma. Ethanol at 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 manufacturing process. Exposure to ethanol did not
appear to affect the physical characteristics of HCV RNA.
Laboratory of Plasma Derivatives, Food and Drug Administration, Bethesda,