Holder P K, Maslanka S E, Pais L B, Dykes J, Plikaytis B D, Carlone G M
Childhood and Vaccine-Preventable Diseases Immunology Section, Centers for Disease Control and Prevention, Atlanta, Georgia 30333.
Clin Diagn Lab Immunol. 1995 Mar;2(2):132-7. doi: 10.1128/cdli.2.2.132-137.1995.
A new standard meningococcal reference serum designated CDC1992 was prepared to replace meningococcal reference sera ECG and PB-2, which are not available in sufficient quantities for continued use as primary reference sera. CDC1992 was prepared from 14 healthy adult volunteers who underwent plasmapheresis 4 to 12 weeks postvaccination with a single dose of a Neisseria meningitidis quadrivalent polysaccharide vaccine. Total and/or class-specific meningococcal serogroup A and C anticapsular antibody concentrations (in micrograms per milliliter) were assigned to CDC1992 by using homologous and heterologous enzyme-linked immunosorbent assay (ELISA) formats. The reference serum ECG was used as a reference standard to assign total anticapsular antibody concentrations to CDC1992 by a homologous ELISA format. A heterologous ELISA format, with the Haemophilus influenzae type b standard reference serum FDA 1983, was used to assign total and class-specific antibody concentrations to CDC1992. Alkaline phosphatase-labeled mouse anti-human monoclonal antibody conjugates were used as secondary antibodies in both ELISA formats. The total, immunoglobulin G (IgG), IgA, and IgM antibody concentrations, assigned to CDC1992 for serogroup A were 135.8, 91.8, 20.1, and 23.9 micrograms/ml, respectively, and those for serogroup C were 32.0, 24.1, 5.9, and 2.0 micrograms/ml, respectively. Meningococcal serogroup A and C antibody concentrations were in good agreement when homologous and heterologous ELISA format results were compared. Total and class-specific serogroup A and C antibody concentrations were determined in six adult quality control serum samples from the Centers for Disease Control and Prevention by using the homologous ELISA and our assigned antibody concentrations for CDC1992. Antibody concentrations in reference sera ECG and PB-2 were measured in order to provide a historical link to previous studies. The general acceptance of CDC1992 as the standard reference serum and the assigned antibody concentrations will allow investigators to compare antibody levels in serum to those in a single reference preparation.
一种新的标准脑膜炎球菌参考血清CDC1992已制备完成，以取代脑膜炎球菌参考血清ECG和PB - 2，因为这两种血清的数量不足以继续作为主要参考血清使用。CDC1992是从14名健康成年志愿者中制备的，这些志愿者在接种单剂量四价脑膜炎奈瑟菌多糖疫苗后4至12周接受了血浆置换。通过使用同源和异源酶联免疫吸附测定（ELISA）方法，将总的和/或特定类别的A群和C群脑膜炎球菌抗荚膜抗体浓度（以微克每毫升计）指定给CDC1992。参考血清ECG被用作参考标准，通过同源ELISA方法将总的抗荚膜抗体浓度指定给CDC1992。使用b型流感嗜血杆菌标准参考血清FDA 1983的异源ELISA方法，将总的和特定类别的抗体浓度指定给CDC1992。碱性磷酸酶标记的小鼠抗人单克隆抗体缀合物在两种ELISA方法中均用作二抗。指定给A群的CDC1992的总抗体、免疫球蛋白G（IgG）、IgA和IgM抗体浓度分别为135.8、91.8、20.1和23.9微克/毫升，C群的分别为32.0、24.1、5.9和2.0微克/毫升。当比较同源和异源ELISA方法的结果时，A群和C群脑膜炎球菌抗体浓度具有良好的一致性。使用同源ELISA和我们为CDC1992指定的抗体浓度，在来自疾病控制和预防中心的六个成人质量控制血清样本中测定了A群和C群总的和特定类别的抗体浓度，并测量了参考血清ECG和PB - 2中的抗体浓度，以便与先前的研究建立历史联系。CDC1992作为标准参考血清及其指定的抗体浓度被广泛接受，将使研究人员能够将血清中的抗体水平与单一参考制剂中的抗体水平进行比较。
