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ELISA Validation for anti-PA Antibody Titer Measurements  

Kim, Yu-Gene (ADD)
Publication Information
Journal of the Korea Institute of Military Science and Technology / v.13, no.3, 2010 , pp. 478-485 More about this Journal
Abstract
The vaccine is biological pretreatment that improves immunity to a particular disease. We can get immunity from producing antibody with injection antigen which has ability to defense against the disease. The ELISA is the most widely used method to measure antibody titer. We have developed and performed validation of ELISA according to the guideline of KFDA and ICH. In this paper, we have verified ELISA method is an excellent method to measure the titer of anti-PA antibody. We have constructed recombinant protective antigen among anthrax toxins and used as antigen of ELISA. In this validation, we have evaluated precision (repeatability, interlaboratory precision), specificity, linearity(range) and LOD, which are validation articles suggested by guideline. Inter-person precision was replaced with inter-laboratory precision. From the results, we have confirmed high precision in all experiments with CV under 20%.
Keywords
Validation; ELISA(Enzyme-Linked Immunosorbent Assay); PA (ProtecTion Antigene); Kfda(Korea Food And Drug Administration); Ich(International Conference of Harmonization); LOD(Limit of Detection); CV(Coefficient of Variation);
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