Fol. Biol. 2016, 62, 241-249
Optimization and Validation of ELISA for Pre-Clinical Trials of Influenza Vaccine
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.
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Funding
This research was supported by a grant from the Ministry of Science and Technological Development of Republic of Serbia (grant number 172049), and financial resources of the Institute of Virology, Vaccines and Sera “Torlak”, Belgrade, Serbia.
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Copyright
This is an open-access article distributed under the terms of the Creative Commons Attribution License.
