Effect of viral nucleic acid testing on contamination frequency of manufacturing plasma pools

Transfusion
C Micha NüblingRainer Seitz

Abstract

In Europe, all plasma pools used for manufacturing of plasma derivatives must be tested negative for hepatitis C virus (HCV) RNA by nucleic acid amplification techniques (NAT) with a defined minimal sensitivity. For a subset of pools, quantitative B19V DNA NAT is also mandatory. NAT for further viral targets was introduced by most of the manufacturers on a voluntary basis. The contamination frequency of plasma pools with HCV RNA, human immunodeficiency virus (HIV)-1 RNA, and hepatitis B virus (HBV) DNA was investigated with representative pools before and after introduction of NAT. A total of 873 pools from 1996 and 331 pools from 2006 were analyzed for the detection of HCV RNA, HIV RNA, and HBV DNA with an automated multiplex NAT system. The pools were obtained from different manufacturers and the source material was of European and US origin. HCV RNA, HIV-1 RNA, and HBV DNA were detectable in plasma pools from 1996 with the following frequencies: 17.8 percent (HCV RNA), 0.8 percent (HIV-1 RNA), and 0.5 percent (HBV DNA). Viral genome concentrations were up to 3 x 10(4) IU HCV RNA per mL and 7 x 10(3) IU HIV RNA per mL, whereas HBV DNA was below the quantitation limit of the quantitative NAT assay. Among the pools from 2006, o...Continue Reading

References

Jun 27, 1996·The New England Journal of Medicine·G B SchreiberJ J Korelitz
Feb 25, 2000·Biologicals : Journal of the International Association of Biological Standardization·C M NüblingJ Löwer
Oct 19, 2002·Transfusion·C Micha NüblingJohannes Löwer

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Citations

Jun 27, 2013·Transfusion Medicine and Hemotherapy : Offizielles Organ Der Deutschen Gesellschaft Fur̈ Transfusionsmedizin Und Immunham̈atologie·Thomas MeyerAxel Pruss
Aug 18, 2009·Biologicals : Journal of the International Association of Biological Standardization·Scott LuteKurt Brorson
Apr 24, 2010·Transplant Infectious Disease : an Official Journal of the Transplantation Society·A PrussW H Gerlich
Jul 9, 2010·Biotechnology and Applied Biochemistry·Pierre-Alain BurnoufThierry Burnouf

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