Diakun K R, Martin D C, Mininni T, Skuse J, Ziembiec N, Quataert S
Wyeth-Lederle Vaccines and Pediatrics, West Henrietta, New York 14586, USA.
Immunol Invest. 1998 Jul-Sep;27(4-5):203-20. doi: 10.3109/08820139809070895.
An enzyme immunoassay is described which quantitates antibodies to Neisseria meningitidis serogroup A capsular polysaccharide in human sera. Modifications of a previously developed two-day assay by Carlone et al. were made to permit analysis in one day and to be compatible with automation. The allowable variations in assay conditions and the areas in which stringent control must be maintained for consistent assay performance are described. Antigen-coating parameters, the kinetics of primary and secondary antibody incubation steps, the buffer compositions, including detergents, serum requirements, and the need for blocking steps were examined. Our modified one-day assay showed excellent agreement with the standardized method of Carlone, with a correlation coefficient between the two methods of 0.989. This assay is adaptable within a permissible range of parameters thus facilitating the implementation of the standardized assay. This will maximize the consistency of results from serum analysis for conjugate vaccine trials related to serotype A Neisseria meningitidis.
本文描述了一种酶免疫测定法，用于定量检测人血清中针对A群脑膜炎奈瑟菌荚膜多糖的抗体。对Carlone等人先前开发的为期两天的测定法进行了改进，使其能够在一天内完成分析，并与自动化兼容。文中描述了测定条件的允许变化范围以及为确保一致的测定性能必须严格控制的方面。研究了抗原包被参数、一抗和二抗孵育步骤的动力学、缓冲液组成（包括去污剂）、血清要求以及封闭步骤的必要性。我们改进的一天测定法与Carlone的标准化方法具有极好的一致性，两种方法之间的相关系数为0.989。该测定法在允许的参数范围内具有适应性，从而便于实施标准化测定。这将使与A群脑膜炎奈瑟菌结合疫苗试验相关的血清分析结果的一致性最大化。
