title: Development of four sandwich ELISAs for quantitation of capsular polysaccharides from Neisseria meningitidis serogroups A, C, W and Y in multivalent vaccines.
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.
authors.affiliation: Research and Development Vice Presidency, Finlay Institute, A.P. 16017, La Habana Cod. 11600, Cuba. Electronic address: fatima8526@gmail.com.
authors.forename: Fátima
authors.initials: F
authors.lastname: Reyes
authors.affiliation: Research and Development Vice Presidency, Finlay Institute, A.P. 16017, La Habana Cod. 11600, Cuba.
authors.forename: Oscar
authors.initials: O
authors.lastname: Otero
authors.affiliation: Research and Development Vice Presidency, Finlay Institute, A.P. 16017, La Habana Cod. 11600, Cuba.
authors.forename: Maribel
authors.initials: M
authors.lastname: Cuello
authors.affiliation: Research and Development Vice Presidency, Finlay Institute, A.P. 16017, La Habana Cod. 11600, Cuba.
authors.forename: Nevis
authors.initials: N
authors.lastname: Amin
authors.affiliation: Research and Development Vice Presidency, Finlay Institute, A.P. 16017, La Habana Cod. 11600, Cuba.
authors.forename: Luis
authors.initials: L
authors.lastname: García
authors.affiliation: Research and Development Vice Presidency, Finlay Institute, A.P. 16017, La Habana Cod. 11600, Cuba.
authors.forename: Daniel
authors.initials: D
authors.lastname: Cardoso
authors.affiliation: Research and Development Vice Presidency, Finlay Institute, A.P. 16017, La Habana Cod. 11600, Cuba.
authors.forename: Frank
authors.initials: F
authors.lastname: Camacho
mesh_terms: D000907:Antibodies, Bacterial / Q000378:metabolism; D016667:Bacterial Capsules / Q000276:immunology; D003955:Diagnostic Tests, Routine; D004797:Enzyme-Linked Immunosorbent Assay; D005240:Feasibility Studies; D006801:Humans; D007074:Immunoglobulin G / Q000378:metabolism; D008589:Meningococcal Infections / Q000276:immunology* / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000145:classification / Q000276:immunology*; D009345:Neisseria meningitidis / Q000276:immunology*; D011135:Polysaccharides, Bacterial; D011786:Quality Control; D015203:Reproducibility of Results
chemical_list: D000907:Antibodies, Bacterial; D007074:Immunoglobulin G; D022401:Meningococcal Vaccines; D011135:Polysaccharides, Bacterial
keywords: Capsular polysaccharide; ELISA; Meningococcal vaccines; Quantitation