ISSN: 0974-276X
Idania Gonzalez Perez
Center of Molecular Immunology, Cuba
Posters & Accepted Abstracts: J Proteomics Bioinform
Background: CIMAvax-EGF�® is a Cuban therapeutic vaccine approved for treatment of advanced non-small cell lung c�¡ncer (NSCLC). By inducing antibodies vs. epidermal growth factor (EGF), it prevents binding of endogenous EGF to its receptor, thereby reducing tumor size and/or its progression. Phase II and III clinical trials carried out in Cuban patients revealed the pre-treatment predictive value of serum EGF concentrations ([sEGF]) for CIMAvax-EGF�® efficacy. Therefore, it makes sense to identify the subset of patients which will be really benefitted with the use of the vaccine, through its stratification by [sEGF] (personalized medicine). The aim of this work was to develop and validate the UMELISA EGF�® kit, the future companion diagnostic kit of CIMAvax-EGF�® vaccine. Methods: The ultra micro analytical system technology (Immunoassay Center, Cuba) was used. The system includes the plate washer and instrumentation for automatic reading, quantification, validation and interpretation of results. Results: A simple sandwich-type ultramicroELISA assay UMELISA EGF�®, based on the advantages of high affinity reaction between streptavidin and biotin, was developed for the measurement of [sEGF]. The best performance was achieved with: plates coated with mAb CBEGF-1 at 6 �¼g/mL, biotinylated mAb CBEGF-2 at 0.5 �¼g/mL, incubation time for sandwich formation of 18-20 hours at 37 �°C and sample volumes of 30 uL. Conclusions: The UMELISA EGF�® kit exhibited similar characteristics to other commercially available assays, in terms of precision, accuracy and dynamic range. Regression analysis showed a good correlation with the commercially available Human EGF Immunoassay Quantikine�® ELISA kit (n=130, Pearson r=0.92, p<0.01) (R&D Systems, USA).
Idania González Pérez has completed her BSc in Physics from the Faculty of Physics, Moscow State University, Russia (1985-1990) and Master of Science in Physics and Mathematics from Faculty of Physics, Moscow State University, Russia. She is now involved in a PhD program at the University School of Medicine in Havana. She is a Senior Researcher at the Center for Molecular Immunology in Havana, Systems Biology Department, Biomarkers Group. She has published more than 15 papers in reputed journals and has been serving as a Reviewer in Medical Science Monitor, Journal of Hospital and Clinical Pharmacy and International Blood Research & Reviews.