增强型抗肺炎球菌抗体电化学发光检测法：验证和与世界卫生组织参考 ELISA 的桥接。
Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA.
机构信息
Merck & Co., Inc., Kenilworth, NJ 07033, USA.
Great Ormond Street Institute of Child Health (ICH), University College London, London, UK.
出版信息
Bioanalysis. 2020 Oct;12(19):1363-1375. doi: 10.4155/bio-2020-0023. Epub 2020 Sep 25.
To re-optimize the pneumococcal (Pn) electrochemiluminescence (ECL) assay and to validate and bridge the enhanced assay to the WHO ELISA, to support the Phase III clinical trial program for V114, a 15-valent Pn conjugate vaccine. The Pn ECL assay was re-optimized, validated and formally bridged to the WHO ELISA. The enhanced Pn ECL assay met all prespecified validation acceptance criteria and demonstrated concordance with the WHO ELISA. The corresponding threshold value remains at 0.35 μg/ml for all 15 serotypes. The enhanced Pn ECL assay has been validated for the measurement of antibodies to 15 Pn capsular polysaccharides and is concordant with the WHO ELISA, supporting its use in clinical trials.
为了重新优化肺炎球菌（Pn）电化学发光（ECL）检测方法，并验证和桥接改良后的检测方法与世界卫生组织（WHO）酶联免疫吸附测定法（ELISA），以支持 V114（一种 15 价肺炎球菌结合疫苗）的 III 期临床试验项目。对肺炎球菌 ECL 检测方法进行了重新优化、验证和正式桥接至世界卫生组织 ELISA。改良后的肺炎球菌 ECL 检测方法满足所有预设的验证接受标准，并与世界卫生组织 ELISA 具有一致性。对于所有 15 种血清型，相应的阈值仍保持在 0.35μg/ml。改良后的肺炎球菌 ECL 检测方法已被验证可用于测量 15 种肺炎球菌荚膜多糖的抗体，与世界卫生组织 ELISA 具有一致性，支持其在临床试验中的应用。
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