Establishment of the first International Standard for human anti-typhoid capsular Vi polysaccharide IgG
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2018Journal
BiologicalsPublisher
Academic PressType
Article
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Vi capsular polysaccharide (Vi) conjugate vaccines, which can prevent typhoid in infants and young children, are being developed. Comparative immunogenicity studies are facilitated by an International Standard (IS) for human anti-Vi IgG. 16/138, a pool of sera from volunteers which received either Vi conjugate vaccine or plain Vi vaccine, was assessed as an IS alongside U.S. reference reagent Vi-IgG R1, 2011 . Samples were tested in a commercial ELISA (n = 7), a standardised ELISA based on biotinylated Vi (n = 7) and in-house ELISAs (n = 7). Valid estimates were obtained for the potency of all samples in the commercial ELISA, and the commutability of 16/138 and Vi-IgG R1, 2011 was evident for the commercial ELISA and in-house ELISAs based on a coating of Vi and protein. The WHO Expert Committee on Biological Standardization established 16/138 as the first IS for anti-Vi IgG with 100 IU per ampoule and assigned 163 IU per vial of Vi-IgG R1, 2011 . Copyright 2018Identifier to cite or link to this item
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85056314133&doi=10.1016%2fj.biologicals.2018.09.001&partnerID=40&md5=8f6cfeabb7aa447109c778733f6ccfc1; http://hdl.handle.net/10713/9672ae974a485f413a2113503eed53cd6c53
10.1016/j.biologicals.2018.09.001
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