title: Validation of quantitative ELISAS for measuring anti-Yersinia pestis F1 and V antibody concentrations in nonhuman primate sera.
abstract: 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.affiliation: United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, Maryland 21702, USA.
authors.forename: C Y
authors.initials: CY
authors.lastname: Lindsey
authors.forename: B S
authors.initials: BS
authors.lastname: Powell
authors.forename: C R
authors.initials: CR
authors.lastname: Bolt
authors.forename: J E
authors.initials: JE
authors.lastname: Brown
authors.forename: J J
authors.initials: JJ
authors.lastname: Adamovicz
mesh_terms: D000818:Animals; D000907:Antibodies, Bacterial / Q000097:blood* / Q000276:immunology*; D000942:Antigens, Bacterial / Q000276:immunology*; D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards*; D005260:Female; D008251:Macaca / Q000097:blood / Q000276:immunology* / Q000382:microbiology*; D008297:Male; D052899:Pore Forming Cytotoxic Proteins / Q000276:immunology*
chemical_list: D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; C043908:LcrV protein, Yersinia; D052899:Pore Forming Cytotoxic Proteins