<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Laura Hassall</style></author><author><style face="normal" font="default" size="100%">Daniel A Yara</style></author><author><style face="normal" font="default" size="100%">Rebecca Riches-Duit</style></author><author><style face="normal" font="default" size="100%">Peter Rigsby</style></author><author><style face="normal" font="default" size="100%">Alexandre Dobly</style></author><author><style face="normal" font="default" size="100%">Maxime Vermeulen</style></author><author><style face="normal" font="default" size="100%">Antoine Francotte</style></author><author><style face="normal" font="default" size="100%">Paul Stickings</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Development of a monoclonal antibody sandwich ELISA for the determination of antigen content and quality in diphtheria vaccines.</style></title><secondary-title><style face="normal" font="default" size="100%">ALTEX</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Antibodies, Monoclonal</style></keyword><keyword><style  face="normal" font="default" size="100%">Diphtheria</style></keyword><keyword><style  face="normal" font="default" size="100%">Diphtheria Toxoid</style></keyword><keyword><style  face="normal" font="default" size="100%">Enzyme-Linked Immunosorbent Assay</style></keyword><keyword><style  face="normal" font="default" size="100%">Humans</style></keyword><keyword><style  face="normal" font="default" size="100%">Tetanus Toxoid</style></keyword><keyword><style  face="normal" font="default" size="100%">vaccines</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2024</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2024 Jan 09</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">41</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;At present, quality control of diphtheria vaccines by both manufacturers and national control laboratories relies heavily on in vivo assays to confirm potency. As part of the VAC2VAC project we have developed a monoclonal antibody (mAb) enzyme-linked immunosorbent assay (ELISA) to measure the relative amount and quality of diphtheria toxoid (DTxd) in diphtheria-tetanus based vaccines and believe this test has the potential to play a key role in a control strategy no longer including an in vivo potency test. The mAb ELISA is highly specific, has good dilutional linearity, and is suitable for detecting DTxd in a range of different human vaccine products. We demonstrate the ability of the assay to discriminate between batches of different content and quality using vaccine batches that were prepared to contain differing amounts of DTxd or were altered by exposure to heat or oxidative stress. We also demonstrate successful transfer of the method to other laboratories and show that different diphtheria antigen materials may be able to serve as a reference antigen for local standardization of the method. The assay is ideally suited for incorporation into a consistency approach for routine diphtheria vaccine quality control testing and may be suitable to serve as the stability indicating test in replacement of the current in vivo potency test.&lt;/p&gt;
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