A novel double-mAb sandwich ELISA utilizing broad-spectrum neutralizing antibodies as an in vitro alternative to the rabies vaccine NIH potency assay

Background

Rabies remains a devastating zoonotic disease, with prevention measures relying heavily on post-exposure prophylaxis (PEP). Evaluating rabies vaccine potency traditionally relies on the in vivo National Institutes of Health (NIH) mouse challenge assay, which is limited by long testing cycles, low reproducibility, and high animal consumption. Developing broad-spectrum monoclonal antibodies (mAbs) and alternative in vitro assays is essential to advance rabies prevention and improve vaccine quality control.