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PCR detects HCV RNA in a plasma pool contaminated by a single preseroconversion donation of genotype 5a.

Thomas, Isabelle
Branckaert, T
Mathys, Esther
Vranckx, R
Laub, R
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Abstract

BACKGROUND AND OBJECTIVES: To determine the prevalence of HCV-RNA-positive plasma pools in Belgium, to validate our PCR method and to increase the safety of the released blood products.

MATERIALS AND METHODS: Plasma pools consisting each of about 5,000 donations from Belgian unpaid volunteer blood donors were analysed by PCR for the presence of HCV RNA. Two different extraction methods were compared and validated.

RESULTS: Two out of 367 plasma pools were found to be HCV RNA positive and were discarded. For one of these two pools, the look-back procedure identified an anti-HCV-negative contaminated donation. The HCV genotype of both the contaminated pool and the donation was 5a, a genotype rare in Europe. The viral load of the preseroconverted donation was 2.9 x 10(7) gEq/ml according to the bDNA method.

CONCLUSION: In the case of plasma derivatives, various important steps are already included to increase safety. Nucleic acid testing of manufacturing plasma pools ensures that viral load in the starting material is as low as possible.

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2000-07-01
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Peer reviewed scientific article
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Belgium, Blood Donors, Consumer Product Safety, Drug Contamination, Genotype, Hepacivirus, Hepatitis C, Humans, polymerase chain reaction, prevalence, Reagent Kits, Diagnostic, Reference Standards, RNA, Viral, Sensitivity and Specificity, Serologic Tests, Viral Load
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