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.
Yoo
Si Hyung
SH
Biologics Headquarters, Korea Food and Drug Administration, 231 Jinheungno Eunpyeong-Gu, Seoul 122-704, Republic of Korea.
Hong
Seung Hee
SH
Jung
Sa Rah
SR
Park
Su Jin
SJ
Lee
Nam Kyung
NK
Kim
Soon Nam
SN
Kang
Sang Mo
SM
Min
Hong Ki
HK
Park
Sue Nie
SN
Hong
Seung Hwa
SH
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