Development of the International Consortium for Blood Safety (ICBS) HCV panels.
To evaluate the sensitivity and specificity of assays used to screen blood for antibody to hepatitis C virus (HCV) infection, the International Consortium for Blood Safety (ICBS) established fully characterized CBS panels. lCBS collected and characterized 1007 anti-HCV-positive plasma units from geographically diverse origins by ELISA, RIBA, RT-PCR, and sequence-based genotyping, 539 of which met the definition of a true positive. Of these, 200 confirmed positive plasma units, representing the 6 major HCV genotypes, were selected to assemble the true-positive constituents of the panel. The negative panel comprises 181 plasma units collected from the USA. The panels have proved valuable for determining the performance of anti-HCV assays thus permitting national authorities, especially in resource-limited countries, to make informed decisions on selection of affordable and reliable assays.
Diaz
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Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Liu
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P
Kuhnert
W L
WL
Healy
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M
Prince
A M
AM
El-Nageh
M M
MM
D001782:Blood Donors; D001803:Blood Transfusion / Q000592:standards; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods* / Q000592:standards; D005838:Genotype; D014943:Global Health; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology*; D006801:Humans; D007390:International Agencies; D008403:Mass Screening / Q000379:methods* / Q000592:standards; D017720:Molecular Epidemiology; D009710:Nucleotide Mapping; D010802:Phylogeny; D012367:RNA, Viral; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods* / Q000592:standards; D017751:Safety Management / Q000458:organization & administration; D012680:Sensitivity and Specificity; D065227:Transfusion Reaction
D012367:RNA, Viral