Application of Bovine Viral Diarrhoea Virus as an Internal Control in Nucleic Acid Amplification Tests for Hepatitis C Virus RNA in Plasma-Derived Products

  • Yoo Si Hyung (Biologics Headquarters, Korea Food and Drug Administration) ;
  • Hong Seung Hee (Biologics Headquarters, Korea Food and Drug Administration) ;
  • Jung Sa Rah (Biologics Headquarters, Korea Food and Drug Administration) ;
  • Park Su Jin (Biologics Headquarters, Korea Food and Drug Administration) ;
  • Lee Nam Kyung (Biologics Headquarters, Korea Food and Drug Administration) ;
  • Kim Soon Nam (Biologics Headquarters, Korea Food and Drug Administration) ;
  • Kang Sang Mo (Department of Microbial Engineering, KonKuk University) ;
  • Min Hong Ki (Biologics Headquarters, Korea Food and Drug Administration) ;
  • Park Sue Nie (Biologics Headquarters, Korea Food and Drug Administration) ;
  • Hong Seung Hwa (Biologics Headquarters, Korea Food and Drug Administration)
  • Published : 2006.02.01

Abstract

Plasma-derived products are produced from plasma via fractionation and chromatography techniques, but can also be produced by other methods. In the performance of nucleic acid amplification tests (NAT) with plasma-derived products, it is necessary to include an internal control for the monitoring of all procedures. In order to avoid false negative results, we confirmed the usefulness of the bovine viral diarrhoea virus (BVDV) for use as an internal control in the detection of hepatitis C virus (HCV) RNA in plasma-derived products. These products, which were spiked with BVDV, were extracted and then NAT was performed. Specificity and sensitivity were determined via the adjustment of primer concentrations and annealing temperatures. BVDV detection allows for validation in the extraction, reverse transcription, and amplification techniques used for HCV detection in plasma-derived products.

Keywords

References

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