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    Establishment of the first International Standard for human anti-typhoid capsular Vi polysaccharide IgG

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    Author
    Rijpkema, S.
    Hockley, J.
    Logan, A.
    Date
    2018
    Journal
    Biologicals
    Publisher
    Academic Press
    Type
    Article
    
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    See at
    https://dx.doi.org/10.1016/j.biologicals.2018.09.001
    Abstract
    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 2018
    Keyword
    ELISA
    IgG
    International standard
    Polysaccharide
    Typhoid
    Vi
    Identifier 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/10713/9672
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.biologicals.2018.09.001
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