一项关于定量检测人抗肺炎链球菌多糖抗体的酶联免疫吸附测定的多实验室评估。
A multi-laboratory evaluation of an enzyme-linked immunoassay quantitating human antibodies to Streptococcus pneumoniae polysaccharides.
作者信息
Quataert S, Martin D, Anderson P, Giebink G S, Henrichsen J, Leinonen M, Granoff D M, Russell H, Siber G, Faden H, Barnes D, Madore D V
机构信息
Wyeth-Lederle Vaccines, Rochester, New York, USA.
出版信息
Immunol Invest. 2001 Aug;30(3):191-207. doi: 10.1081/imm-100105064.
An enzyme-linked immunoassay (EIA) is described and evaluated which quantitates human antibodies to serotype specific S. pneumoniae polysaccharide (PnPs) in human sera. Based on the observations previously described by Koskela (1), native PnPs are used as coating antigens and sera are absorbed with a soluble pneumococcal absorbant material containing C-polysaccharide (CPs) to ensure measurement of serotype specific anti-PnPs antibodies. The robustness of this method was evaluated by ten laboratories using the same reagents, protocol, and five human serum samples. Reproducible antibody values were obtained for IgM, IgG, and IgA antibodies to five different PnPs serotypes, 3, 6B, 14, 19F, and 23F. The overall mean percent coefficients of variation in this interlaboratory study for all five selotype specific anti-PnPs determinations with the five coded sera were 30% for IgG, 3/% for IgM, and 36% for IgA. This assay can be standardized for quantitation of serotype specific anti-PnPs antibodies, allowing comparison of antibody values in vaccine trials evaluating pneumococcal vaccines.
本文描述并评估了一种酶联免疫吸附测定法（EIA），该方法用于定量检测人血清中针对肺炎链球菌特定血清型多糖（PnPs）的人抗体。基于科斯凯拉（1）之前描述的观察结果，使用天然PnPs作为包被抗原，并用含有C多糖（CPs）的可溶性肺炎球菌吸附材料吸收血清，以确保检测特定血清型的抗PnPs抗体。十个实验室使用相同的试剂、方案和五份人血清样本对该方法的稳健性进行了评估。针对五种不同的PnPs血清型3、6B、14、19F和23F，获得了针对IgM、IgG和IgA抗体的可重复抗体值。在这项实验室间研究中，使用五种编码血清对所有五种血清型特异性抗PnPs测定的总体平均变异系数百分比，IgG为30%，IgM为33%，IgA为36%。该检测方法可标准化用于定量血清型特异性抗PnPs抗体，从而能够在评估肺炎球菌疫苗的疫苗试验中比较抗体值。
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