Validation of Adapted Neutralization Assays Developed to Discriminate Anti-Rabies Virus Activity of Two Different Anti-Rabies Virus Monoclonal Antibodies Administered as a Combination

Assessment of rabies virus (RABV) neutralizing antibodies in subjects vaccinated or injected with anti-RABV immunoglobulins is central determination protection. The rapid fluorescent focus inhibition test (RFFIT) used for assessment activity serum. current polyclonal preparations on the market pose difficulties production and vary quality. RABV monoclonal (MAbs) are being evaluated as replacements. Different MAbs may neutralize different isolates, thus two more directed against epitopes glycoprotein needed. It therefore important to ensure all isolates sera an MAb product consisting MAbs. RFFIT, utilizing CVS-11 challenge virus, cannot discriminate between activities We developed validated RFFIT methods enabling specific (CR57 CR4098) using mutant strains resistant either CR57 CR4098 neutralization. validation results demonstrate that both assays precise, accurate, linear, specific, stable within linear range 0.025 IU/mL 1.0 IU/mL. This method design can, therefore, be determine human serum samples.