Integration and optimization of potency evaluation biomarkers to develop antibody detection ELISA for discriminating neutralization potency of antiserum against neurotoxic snakes

Taiwan CDC has been using in vivo murine assay over decades in accessing antiserum titers against snake venom among immunized horses. However, the necessity of using mice in preclinical testing for efficacy of snake antivenom has been critiqued recently. In following the rules of 3Rs to protect the welfare of model animals, we plan to develop an ELISA assay to monitor the neutralization potency of neurotoxic snake (N. atra and B. multicinctus) antiserum as an alternative protocol to reduce the suffering and damages of the rodents. In our previous study, we have discovered and verified the biomarkers for distinguishing the neutralization potency of antiserum against N. atra. Furthermore, we also identified potential biomarkers for discriminating the neutralization potency of antiserum against B. multicinctus. In this proposal, we plan to use several batches of horse antiserum with known neutralization potency to verify the best biomarker for distinguishing the neutralization potency of antiserum against B. multicinctus. Then, we will combine the two biomarkers, verified to be useful in differentiating the neutralization potency of equine antiserum against N. atra and B. multicinctus, respectively, to develop the antibody detection ELISA. This ELISA prototype will have the ability to discriminate the high-potency and low-potency of equine antiserum toward either N. atra or B. multicinctus in the manufacturing process of antivenom production.

Project ID:PG11101-0001
External Project ID:MOHW111-CDC-C-114-000107