title: The impact of hepatitis C antibody screening of source plasma donors on hepatitis C virus RNA in factor VIII concentrates.
abstract: We have used the polymerase chain reaction technique for the detection of hepatitis C RNA in nine different plasma-derived factor VllI concentrates and in two factor IX concentrates. Four concentrates were investigated both prior to and after the introduction of donor screening for hepatitis C antibodies. A negative reaction was consistently found in the ultra-pure factor VIII concentrates Octonativ-M (Pharmacia) and Hemofil M (Baxter), both prepared by affinity purification with factor VI1I:C monoclonal antibodies and virus inacti- vated hy solvent/detergent procedures, as well as in both the low-purity factor IX concentrates. I f produced from unscreened plasma, the other factor VIII concentrates manifested positive reactions irrespective of preparation procedure and type of virus inactivation or the temperature at which it was performed. We conclude that the preparation procedure of clotting factor concentrates, rather than type of virus inactivation, determines the degree of contamination by hepatitis C virus RNA, and that screening of source plasma seems effective in removing hepatitis C RNA from the final product as determined with a sensitive PCR method. I t is important to stress that the presence of viral RNA does not necessarily imply clinical infectivity.
authors.affiliation: Departments of Coagulation Disorders and Medical Microbiology, University of Lund, University Hospital, Malmö, and Swedish Institute for Infectious Disease Control, Stockholm, Sweden.
authors.forename: E
authors.initials: E
authors.lastname: Berntorp
authors.affiliation: Departments of Coagulation Disorders and Medical Microbiology, University of Lund, University Hospital, Malmö, and Swedish Institute for Infectious Disease Control, Stockholm, Sweden.
authors.forename: S
authors.initials: S
authors.lastname: Lethagen
authors.affiliation: Departments of Coagulation Disorders and Medical Microbiology, University of Lund, University Hospital, Malmö, and Swedish Institute for Infectious Disease Control, Stockholm, Sweden.
authors.forename: E
authors.initials: E
authors.lastname: Nordenfelt
authors.affiliation: Departments of Coagulation Disorders and Medical Microbiology, University of Lund, University Hospital, Malmö, and Swedish Institute for Infectious Disease Control, Stockholm, Sweden.
authors.forename: A S
authors.initials: AS
authors.lastname: Månsson
authors.affiliation: Departments of Coagulation Disorders and Medical Microbiology, University of Lund, University Hospital, Malmö, and Swedish Institute for Infectious Disease Control, Stockholm, Sweden.
authors.forename: S
authors.initials: S
authors.lastname: Månsson
authors.affiliation: Departments of Coagulation Disorders and Medical Microbiology, University of Lund, University Hospital, Malmö, and Swedish Institute for Infectious Disease Control, Stockholm, Sweden.
authors.forename: A
authors.initials: A
authors.lastname: Widell
keywords: Keywords:; factor IX; factor VIII; hepatitis C PCR; polymerase chain reaction.