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Development of four sandwich ELISAs for quantitation of capsular polysaccharides fromNeisseria meningitidisserogroups A, C, W and Y in multivalent vaccines

Authors
Journal
Journal of Immunological Methods
0022-1759
Publisher
Elsevier
Volume
407
Identifiers
DOI: 10.1016/j.jim.2014.03.020
Keywords
  • Quantitation
  • Elisa
  • Capsular Polysaccharide
  • Meningococcal Vaccines
Disciplines
  • Biology
  • Chemistry
  • Medicine

Abstract

Abstract Neisseria meningitidis is a Gram negative bacterium that has been classified in 13 serogroups according to the biochemical composition of the capsular polysaccharide (CP). However, invasive infections are most frequently caused by six of these serogroups: A, B, C, W, X and Y (MenA, MenB, MenC, MenW, MenX, MenY). Individual CP quantitation in multivalent meningococcal CP-based vaccines is required for quality control testing of these products. In this regard, four sandwich enzyme-linked immunosorbent assays (ELISAs) were developed for the quantitation of CP. The quantitation and detection limits of the four ELISAs were below 1ng/mL. The assays showed good reproducibility and repeatability as calculated for each point of the standard curve (CV<15%). In addition, five multivalent meningococcal CP-based vaccines were evaluated and the proposed ELISAs showed that these vaccines were found into the accepted range (±30%) of CP content. These assays are suitable for screening multiple plain or conjugated meningococcal CP-based vaccines and could be useful for monitoring lot-to-lot consistency and stability analysis.

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