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Development and validation of a quantitative competitive ELISA for potency testing of equine anti rabies sera with other potential use

机译：用于马抗狂犬病血清效力测试的定量竞争ELISA的开发和验证

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In case of a bite by a rabies infected animal, the World Health Organisation recommends a prophylactic treatment including the administration of Human Rabies Immunoglobulins (HRIGs) or highly purified F(ab')2 fragments produced from Equine Rabies Immunoglobulin (F(ab')(2) - ERIGs). According to international regulation, quality control of F(ab')(2) - ERIGs lots requires potency testing by the in vivo Mouse Neutralisation Test (MNT) prior marketing. However, the strategy of the 3Rs (Reduce, Refine, Replace) for animal testing required by the European Directive encourages the replacement of the in vivo potency test by an in vitro assay. In this context, a competitive ELISA method (c-ELISA) has been developed by the Agence Nationale de Securite du Medicament et des Produits de Sante where F(ab')(2) - ERIGs are in competition with a monoclonal antibody recognizing the trimeric native form of the rabies glycoprotein. After a full validation study, the c-ELISA has been applied to commercial batches of F(ab')(2) - ERIGs. A correlation study with the MNT demonstrated a similarity between the two methods (r = 0.751). Moreover, the c-ELISA method which does not need any species specific reagent has been applied to HRIGs potency testing as an alternative method to Rapid Fluorescent Focus Inhibition Test (RFFIT), thus avoiding the handling of live rabies virus in BSL3 containment. In conclusion, the c-ELISA has shown its potential to replace MNT and possibly RFFIT for the quantification of rabies immunoglobulin. After optimisation it may be used for the quantification of rabies immunoglobulin in any animal species, notably for rabies immunogenicity assay in mice. (C) 2016 Elsevier Ltd. All rights reserved.
机译：如果被狂犬病感染的动物咬伤，世界卫生组织建议采取预防措施，包括给予人类狂犬病免疫球蛋白（HRIG）或从马狂犬病免疫球蛋白（F（ab'）生产的高度纯化的F（ab'）2片段（2）-ERIG）。根据国际法规，对F（ab'）（2）-ERIGs批次的质量控制需要事先通过体内小鼠中和测试（MNT）进行效能测试。但是，欧洲指令要求的3R（减少，优化，替换）动物测试策略鼓励通过体外测定法代替体内效价测试。在这种情况下，法国国立安全生产和发展局开发了一种竞争性ELISA方法（c-ELISA），其中F（ab'）（2）-ERIG与识别三聚体的单克隆抗体竞争狂犬病糖蛋白的天然形式。经过全面的验证研究，c-ELISA已应用于商业批次的F（ab'）（2）-ERIGs。与MNT的相关性研究表明两种方法之间具有相似性（r = 0.751）。此外，作为快速荧光聚焦抑制试验（RFFIT）的替代方法，不需要任何物种特异性试剂的c-ELISA方法已应用于HRIG效能测试，从而避免了在BSL3容器中处理活狂犬病病毒。总之，c-ELISA已显示出替代MNT以及可能替代RFFIT定量狂犬病免疫球蛋白的潜力。优化后，可用于定量任何动物物种中的狂犬病免疫球蛋白，特别是用于小鼠中的狂犬病免疫原性测定。 （C）2016 Elsevier Ltd.保留所有权利。

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