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VALIDATION OF QUANTITATIVE ELISAs FOR MEASURING ANTI-YERSINIA PESTIS F1 AND V ANTIBODY CONCENTRATIONS IN NONHUMAN PRIMATE SERA.
MedLine Citation:
PMID:  22181824     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
This study systematically validated two quantitative enzyme-linked immunosorbent assays (ELISAs) for determining Yersinia pestis anti-F1 or anti-V IgG concentration in cynomolgus macaque sera. The results demonstrated that these ELISAs are reliable, reproducible, and suitable for their intended use to measure both anti-F1 and anti-V IgG in monkey sera following vaccination with a heterologous recombinant fusion F1-V protein (rF1-V). Statistical analysis demonstrated assay precision, accuracy, specificity, linearity/dilutional linearity, and robustness for both assays. The quantitative ranges of standard curves were defined as 40-700 ng/mLfor both anti-F1 and anti-V IgG. Either serological assay could be used to determine potency of F1/V antigen-based vaccines in surrogate clinical studies or to define correlates of protective immunity against plague under the Food and Drug Administration's (FDA) two-animal rule.
Authors:
C Y Lindsey; B S Powell; C R Bolt; J E Brown; J J Adamovicz
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of immunoassay & immunochemistry     Volume:  33     ISSN:  1532-4230     ISO Abbreviation:  J Immunoassay Immunochem     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2011-12-20     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100963688     Medline TA:  J Immunoassay Immunochem     Country:  England    
Other Details:
Languages:  eng     Pagination:  91-113     Citation Subset:  IM    
Affiliation:
a United States Army Medical Research Institute of Infectious Diseases , Fort Detrick , Maryland , USA.
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