The Primary Exploration Of Biological Change Initiated By Gene Therapy And Clinical Trial On Syphilis Antibody Measurement By Latex Enhanced Turbidimetric Immunoassay

As we know, gene therapy may induce unpredictable biological risk. So, to control the safety of the gene therapy, it needs sme available monitor biomakers.To explore the safety biomarker of gene therapy, the study observed biological changes on the organism when received gene therapy. Made the gene therapy model by transfected rats with rAAV2-hGH-EGFP, and then screened routine biochemistry indexes. Serum of the patients using Gendicine were Collected to evaluate small serum proteins by the proteome empirical method.Injecting rAAV2-hGH-EGFP into the rat's leg muscle locally could increase the mass quality of the muscle, while biochemistry indexes and organic morphous no significant change, except the muscle. So, it could be draw that rAAV2-hGH-EGFP was safe and available for the transfection. Analyzed the serum before and after gene therapy by two-dimensional electrophoresis. There were more then 40 protein points showing significant change. From the results of the micromolecule proteins mass spectrum, could find some changes in serum proteins. Whether the safety monitor biomarkers for the gene therapy belong to these changes or not, it would need more samples to detect and further study.As the same time, observed the ability of Latex enhanced turbidimetric Immunoassay (LETIA) detecting TP antibodies. LETIA had the same ability on detecting TP antibodies as TPPA. Screened the population joining in health examination for TP antibodies, almost every negative value was far from cut-ff value. So, LETIA had great sensitivity and specificity.