Standardization: a progress report.
The introduction of nucleic acid amplification technology (NAT) assays for the detection of viral contamination of blood and blood products requires the availability of well-characterized reference reagents. Working reagents for hepatitis C virus RNA, hepatitis B virus DNA, HIV-1 RNA and human parvovirus B19 DNA have been established at NIBSC and at many other laboratories (both official medicinal control laboratories and commercial laboratories). However, as these reagents have been characterised independently, it is difficult to compare results from assays using different working reagents. Recently, a WHO International Standard was established for HCV RNA NAT assays. This standard has been calibrated in International Units (IU) and provides a common standard against which all working reagents can be calibrated. Collaborative studies to characterise two further candidate International Standards for HBV DNA and HIV-1 RNA NAT assays have been completed.
Saldanha
J
J
Division of Virology, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Herts, EN6 3QG, U.K.
D001771:Blood Banks / Q000592:standards; D001782:Blood Donors; D001803:Blood Transfusion; D004279:DNA, Viral / Q000097:blood* / Q000235:genetics*; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification; D016174:Hepacivirus / Q000302:isolation & purification; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D007202:Indicators and Reagents; D021141:Nucleic Acid Amplification Techniques; D016732:Parvovirus B19, Human / Q000235:genetics / Q000302:isolation & purification; D011786:Quality Control; D012367:RNA, Viral / Q000097:blood* / Q000235:genetics*; D012015:Reference Standards; D014944:World Health Organization
D004279:DNA, Viral; D007202:Indicators and Reagents; D012367:RNA, Viral