Detection and Quantitation of HCV-RNA in Immune Globulins Produced by Cohn-Oncley Fractionation of Human Plasma

The epidemiology of virus transmission by plasma derivatives: clinical studies verifying the lack of transmission of hepatitis B and C viruses and HIV type 1

“…Although many lots of IGIM made before 1994 were found in later studies to have had detectable HCV RNA, 33,34 HCV has never been transmitted by IGIM. It has been shown that plasma pools made from donations screened by second‐generation multi‐antigen assays for anti‐HCV had no detectable HCV RNA by PCR, whereas 90 percent of plasma pools made before the introduction of any anti‐HCV screening did have HCV RNA 35 .…”

Editorial

“…Analysiert man die in der Vergangenheit beobachteten Fälle von Virusübertragungen (Chudy et al, 1995), so wird deutlich, daû es verschiedentlich HCV-Übertragungen mit intravenös angewendeten Immunglobulinen gegeben hat. Die letzten Fälle traten 1993/1994 auf (Yu et al, 1994(Yu et al, , 1995…”

Safety and availability of immunoglobulin replacement therapy in relation to potentially transmissable agents

“…Subsequent studies showed that several lots of immunoglobulin had high levels of HCV-RNA by polymerase chain reaction (PCR). 28 It was surprising that more than half the commercial intramuscular immunoglobulin preparations were also HCV-RNA positive, despite the absence of HCV transmission by this type of immunoglobulin. PCR methods detect viral nucleic acid during the viraemic stage and could be used to overcome the 'window' periods in HCV and HIV.…”

“…31 However, the role of partitioning of viruses cannot be taken in isolation; when antibodies to HCV were removed following the introduction of screening, the amount of recoverable HCV-RNA in the various Cohn fractions changed dramatically as a result of the virus no longer being complexed with antibody. 28 …”