A NAT for reliable HCV RNA detection from plasma and plasma-derived medicinal products

  • Yoo, Si-Hyung (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administration) ;
  • Jung, Sa-Rah (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administratio) ;
  • Park, Su-Jin (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administratio) ;
  • Kim, Sun-Nam (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administratio) ;
  • Hong, Choong-Man (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administratio) ;
  • Lee, Ki-Hong (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administratio) ;
  • Oh, Ho-Jung (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administratio) ;
  • Kang, Hye-Na (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administratio) ;
  • Shin, In-Soo (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administration) ;
  • Choi, Seoung-Eun (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administration) ;
  • Hong, Sung-Ran (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administration) ;
  • Lee, Seok-Ho (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administration) ;
  • Hong, Seung-Hwa (Blood Products Division, Biologics Evaluation Department, Korea Food and Drug Administration)
  • 발행 : 2002.10.01

초록

HCV is transmitted via various plasma-derived medicinal products. The transmission of HCV could. however, be prevented by screening plasma pools with NAT and validating HCV viral clearance during the manufacturing of plasma derivatives, Although various screening methods including commercial kits are available. it is yet to develop an analytical method to detect HCV in both plasma and plasma derivatives. The objective of this study was to develop a reliable in house method for reliable for the HCV RNA detection from plasma and plasma derivatives. (omitted)

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