Validation of Automated Dilution and Transfer Methods for Rapid Assessment of Functional Immune Responses to Meningococcal Vaccines
Validation of Automated Dilution and Transfer Methods for Rapid Assessment of Functional Immune Responses to Meningococcal Vaccines作者机构：Vaccines Basic Research Merck Sharp and Dohme Corp. West Point USA Vaccines Basic Research Merck Sharp and Dohme Corp. West Point USA.
出 版 物：《World Journal of Vaccines》 (疫苗（英文）)
年 卷 期：2013年第3卷第3期
页 面：98-101页
学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学]
主 题：Serum Bactericidal Assay SBA Neisseria meningitides Automation Repeatability
摘 要：A high-throughput Serum Bactericidal Assay (SBA) was developed to monitor the functional antibody responses to capsular polysaccharide antigens from multiple serotypes of Neisseria meningitidis. This assay measures the ability of an antibody, aided by complement, to mediate killing of bacteria. Functional assays of this type are increasingly used in the quality control arena as potency release tests. Consequently, there has been an enhanced requirement for reproducibility in the performance of this type of assay. Assay validation is, therefore, important to facilitate understanding of the significance of values obtained, and to enable appropriate and informed use of the assay. This study involved the evaluation of the high-throughput serum bactericidal assay including the effects of different dilution and transfer techniques on assay performance. The results presented here demonstrate the repeatability, and the precision and ruggedness of the assay.
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