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dc.contributor.authorRigsby, P.
dc.contributor.authorBeamish, E.
dc.contributor.authorPasetti, M.F.
dc.date.accessioned2020-07-07T19:59:46Z
dc.date.available2020-07-07T19:59:46Z
dc.date.issued2020
dc.identifier.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85086833992&doi=10.1016%2fj.biologicals.2020.05.002&partnerID=40&md5=da22f7e0f14322915a00ed90a04fdab2
dc.identifier.urihttp://hdl.handle.net/10713/13244
dc.description.abstractTyphoid vaccines based on protein-conjugated capsular Vi polysaccharide (TCVs) prevent typhoid in infants and young children. Analysis of the serum anti-Vi IgG response following immunisation against typhoid confirms the immunogenicity of TCVs and forms an important part of the pathway to licensing. Comparative studies could expedite the licencing process, and the availability of a standardised ELISA method alongside the 1st International Standard (IS) 16/138 for anti-typhoid capsular Vi polysaccharide IgG (human) will facilitate this process. To this end, a non-commercial ELISA based on a coat of Vi and poly-L-lysine (Vi-PLL ELISA) was evaluated by 10 laboratories. Eight serum samples, including IS 16/138, were tested in the standardised Vi-PLL ELISA (n = 10), a commercial Vi ELISA (n = 3) and a biotinylated Vi ELISA (n = 1). Valid estimates of potencies relative to IS 16/138 were obtained for all samples in the Vi-PLL ELISA and the commercial ELISA, with good repeatability and reproducibility evident from the study results and concordant estimates obtained by the two ELISA methods. The study demonstrates that the Vi-PLL ELISA can be used in clinical trial studies to determine the immunogenicity of TCVs. Copyright 2020 The Author(s)en_US
dc.description.sponsorshipBill and Melinda Gates Foundation, BMGF OPP 1145952en_US
dc.description.urihttps://doi.org/10.1016/j.biologicals.2020.05.002en_US
dc.language.isoen_USen_US
dc.publisherAcademic Pressen_US
dc.relation.ispartofBiologicals
dc.subjectELISAen_US
dc.subjectIgGen_US
dc.subjectPoly-L-lysineen_US
dc.subjectPolysaccharideen_US
dc.subjectTyphoiden_US
dc.subjectVien_US
dc.titleEvaluation of a standardised Vi poly-L-lysine ELISA for serology of Vi capsular polysaccharide antibodiesen_US
dc.typeArticleen_US
dc.identifier.doi10.1016/j.biologicals.2020.05.002


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