Validation of the rapid fluorescent focus inhibition test (RFFIT) for rabies virus neutralizing antibodies in clinical samples


Show simple item record Kostense, Stefan Moore, Susan M. Companjen, Arjen Bakker, Alexander B. H. Marissen, Wilfred E. von Eyben, Rie Weverling, Gerrit Jan Hanlon, Cathleen A. Goudsmit, Jaap 2012-08-17T20:46:50Z 2012-08-17T20:46:50Z 2012-08-17
dc.description.abstract Monoclonal antibodies are successful biologics in treating a variety of diseases, including the prevention or treatment of viral infections. CL184 is a 1:1 combination of two human monoclonal IgG1 antibodies (CR57 and CR4098) against rabies virus, produced in the PER.C6 human cell line. The two antibodies are developed as replacements of human rabies immune globulin (HRIG) and equine rabies immune globulin (ERIG) in postexposure prophylaxis (PEP). The rapid fluorescent focus inhibition test (RFFIT) is a cell-based virus neutralization assay which is usually performed to determine the biological potency of a vaccine and to measure the levels of protection against rabies in humans and animals. In order to confirm the suitability of this assay as a pharmacodynamic assay, we conducted a validation using both HRIG- and CL184-spiked serum samples and sera from vaccinated donors. The validation results met all analytical acceptance criteria and showed that HRIG and CL184 serum concentrations can be compared. Stability experiments showed that serum samples were stable in various suboptimal conditions but that rabies virus should be handled swiftly once thawed. We concluded that the assay is suitable for the measurement of polyclonal and monoclonal rabies neutralizing antibodies in clinical serum samples. en_US
dc.relation.uri en_US
dc.subject RFFIT en_US
dc.subject RVNA en_US
dc.subject Rabies virus en_US
dc.subject Monoclonal antibodies en_US
dc.subject HRIG en_US
dc.subject Validation en_US
dc.title Validation of the rapid fluorescent focus inhibition test (RFFIT) for rabies virus neutralizing antibodies in clinical samples en_US
dc.type Article (author version) en_US 2012 en_US
dc.citation.doi doi:10.1128/AAC.06179-11 en_US
dc.citation.epage 3530 en_US
dc.citation.issue 7 en_US
dc.citation.jtitle Antimicrobial Agents and Chemotherapy en_US
dc.citation.spage 3524 en_US
dc.citation.volume 56 en_US
dc.contributor.authoreid smoore en_US
dc.contributor.authoreid chanlon en_US

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