Application of bovine viral diarrhoea virus as an internal control in nucleic acid amplification tests for hepatitis C virus RNA in plasma-derived products.
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.
Biologics Headquarters, Korea Food and Drug Administration, 231 Jinheungno Eunpyeong-Gu, Seoul 122-704, Republic of Korea.
Si Hyung
SH
Yoo
Seung Hee
SH
Hong
Sa Rah
SR
Jung
Su Jin
SJ
Park
Nam Kyung
NK
Lee
Soon Nam
SN
Kim
Sang Mo
SM
Kang
Hong Ki
HK
Min
Sue Nie
SN
Park
Seung Hwa
SH
Hong
D000818:Animals; D001908:Diarrhea Viruses, Bovine Viral / Q000235:genetics / Q000302:isolation & purification*; D016174:Hepacivirus / Q000302:isolation & purification; D006526:Hepatitis C / Q000175:diagnosis / Q000821:virology*; D006801:Humans; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D010949:Plasma / Q000737:chemistry* / Q000821:virology*; D012367:RNA, Viral / Q000097:blood*; D012015:Reference Standards; D012680:Sensitivity and Specificity
D012367:RNA, Viral