title: Optimization and Validation of ELISA for Pre-Clinical Trials of Influenza Vaccine.
abstract: Testing of every new vaccine involves investigation of its immunogenicity, which is based on monitoring its ability to induce specific antibodies in animals. The fastest and most sensitive method used for this purpose is enzyme-linked immunosorbent assay (ELISA). However, commercial ELISA kits with whole influenza virus antigens are not available on the market, and it is therefore essential to establish an adequate assay for testing influenza virusspecific antibodies. We developed ELISA with whole influenza virus strains for the season 2011/2012 as antigens and validated it by checking its specificity, accuracy, linearity, range, precision, and sensitivity. The results show that we developed high-quality ELISA that can be used to test immunogenicity of newly produced seasonal or pandemic vaccines in mice. The pre-existence of validated ELISA enables shortening the time from the process of vaccine production to its use in patients, which is particularly important in the case of a pandemic.
authors.affiliation: Institute of Virology, Vaccines and Sera "Torlak", Belgrade, Serbia.
authors.forename: K
authors.initials: K
authors.lastname: Mitic
authors.affiliation: Institute of Virology, Vaccines and Sera "Torlak", Belgrade, Serbia.
authors.forename: L
authors.initials: L
authors.lastname: Muhandes
authors.affiliation: Institute of Virology, Vaccines and Sera "Torlak", Belgrade, Serbia.
authors.forename: R
authors.initials: R
authors.lastname: Minic
authors.affiliation: Institute of Virology, Vaccines and Sera "Torlak", Belgrade, Serbia.
authors.forename: V
authors.initials: V
authors.lastname: Petrusic
authors.affiliation: Institute of Virology, Vaccines and Sera "Torlak", Belgrade, Serbia.
authors.forename: I
authors.initials: I
authors.lastname: Zivkovic
mesh_terms: D000818:Animals; D000914:Antibodies, Viral / Q000276:immunology; D000956:Antigens, Viral / Q000276:immunology; D002986:Clinical Trials as Topic; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000276:immunology; D007252:Influenza Vaccines / Q000276:immunology*; D057230:Limit of Detection; D016014:Linear Models; D051379:Mice; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014771:Virion / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D000956:Antigens, Viral; D007074:Immunoglobulin G; D007252:Influenza Vaccines