Carlone G M, Frasch C E, Siber G R, Quataert S, Gheesling L L, Turner S H, Plikaytis B D, Helsel L O, DeWitt W E, Bibb W F
Menigitis and Special Pathogens Branch, Centers for Disease Control, Atlanta, Georgia 30333.
J Clin Microbiol. 1992 Jan;30(1):154-9. doi: 10.1128/jcm.30.1.154-159.1992.
There is no standard immunoassay for evaluating immune responses to meningococcal vaccines. We developed an enzyme-linked immunosorbent assay to measure total levels of antibody to Neisseria meningitidis group A capsular polysaccharide. Five laboratories measured the antibody levels in six paired pre- and postvaccination serum samples by using the enzyme-linked immunosorbent assay. Methylated human serum albumin was used to bind native group A polysaccharide to microtiter plate surfaces. The between-laboratory coefficients of variation for pre- and postvaccination sera had ranges of 31 to 91 and 17 to 31, respectively. The mean laboratory coefficients of variation for pre- and postvaccination sera, respectively, were 17 and 11 (Molecular Biology Laboratory, Centers for Disease Control), 12 and 15 (Immunodiagnostic Methods Laboratory, Centers for Disease Control), 22 and 19 (Dana-Farber Cancer Institute), 38 and 38 (Bacterial Polysaccharide Laboratory, U.S. Food and Drug Administration), and 11 and 10 (Praxis Biologics, Inc.). Standardization of this enzyme-linked immunosorbent assay should allow interlaboratory comparison of meningococcal vaccine immunogenicity, thus providing a laboratory-based assessment tool for evaluating meningococcal vaccines.
目前尚无用于评估对脑膜炎球菌疫苗免疫反应的标准免疫测定方法。我们开发了一种酶联免疫吸附测定法来测量抗A群脑膜炎奈瑟菌荚膜多糖抗体的总水平。五个实验室使用该酶联免疫吸附测定法测量了六对疫苗接种前后血清样本中的抗体水平。使用甲基化人血清白蛋白将天然A群多糖结合到微量滴定板表面。接种疫苗前和接种疫苗后血清的实验室间变异系数范围分别为31%至91%和17%至31%。接种疫苗前和接种疫苗后血清的实验室平均变异系数分别为：17%和11%（疾病控制中心分子生物学实验室）、12%和15%（疾病控制中心免疫诊断方法实验室）、22%和19%（达纳-法伯癌症研究所）、38%和38%（美国食品药品监督管理局细菌多糖实验室）以及11%和10%（普瑞克斯生物制品公司）。这种酶联免疫吸附测定法的标准化应能实现实验室间对脑膜炎球菌疫苗免疫原性的比较，从而为评估脑膜炎球菌疫苗提供一种基于实验室的评估工具。
