HIGHLY SENSITIVE IMMUNOASSAY FOR RAPID QUANTIFICATION OF MENINGOCOCCAL CAPSULAR POLYSACCHARIDE ANTIGENS

摘要

The present disclosure relates to the field of immunoassays for Gram negative bacteria, in particular N. meningitidis. The disclosure provides a simple and affordable immunoassay to quantitate polysaccharides in meningococcal vaccines for the evaluation of antigen content and lot-to-lot manufacturing consistency. The inventors have found a Sandwich ELISA that can be applicable for the quantitation and identification of N. meningitidis serogroup X polysaccharide in a multivalent meningococcal polysaccharide-protein conjugate vaccine as well as in a multivalent meningococcal plain polysaccharide vaccine. Said assay employs a polyclonal antibody as capture antibody and a novel monoclonal antibody against serogroup X polysaccharide as detection antibody. Further the assay is rapid, robust and reproducible.

主权项

1. A method for the detection and/or quantification of N. meningitidis serogroup X capsular polysaccharide in a sample which method comprises:
providing a solid support coated with polyclonal antibody; providing a sample; applying the sample to the polyclonal antibody coated solid support; removing unbound sample; providing monoclonal antibody; applying the monoclonal antibody to the solid support; removing unbound monoclonal antibody; applying labeled secondary antibody; and detecting the label; wherein the said capture polyclonal antibody and detection monoclonal antibody recognize two distinct non-overlapping epitopes of N. meningitidis Serogroup X capsular polysaccharide.