Abstract：
Two candidate International Standards for meningococcal capsular group W and Y (MenW and MenY, respectively) polysaccharides were assessed for their suitability as quantitative standards in various physicochemical assays. The study was designed to evaluate the intended purpose of these standards, namely, to standardize the quantification of the respective polysaccharide content in meningococcal polysaccharide and conjugate vaccines and their intermediate components. Twelve laboratories from eleven different countries participated in the collaborative study of candidate preparations for International Standards for MenW and MenY polysaccharide (coded 16/152 and 16/206, respectively). Unitage was assigned using the Resorcinol assay. Our proposals, on the basis of data from the Resorcinol assay were: 1) candidate standard for MenW polysaccharide (16/152) to be assigned a content of 1.015 ± 0.071 mg MenW polysaccharide per ampoule (expanded uncertainty with coverage factor k = 2.13, corresponding to a 95 % level of confidence) and 2) candidate standard for MenY polysaccharide (16/206) be assigned a content of 0.958 ± 0.076 mg MenY polysaccharide per ampoule (expanded uncertainty with coverage factor k = 2.26, corresponding to a 95 % level of confidence). The amount of polysaccharide per ampoule remained consistent under all stability conditions over a 36-month period.
摘要：
脑膜炎球菌荚膜组W和Y的两个候选国际标准（MenW和MenY，分别）评估了多糖在各种物理化学测定中作为定量标准的适用性。该研究旨在评估这些标准的预期目的，即,标准化脑膜炎球菌多糖和结合疫苗及其中间成分中各自多糖含量的定量。来自11个不同国家的12个实验室参与了MenW和MenY多糖国际标准候选制剂的合作研究（分别编码为16/152和16/206）。使用间苯二酚测定法分配单位。我们的建议,根据间苯二酚测定的数据有:1)MenW多糖候选标准品(16/152)的含量为1.015±0.071mgMenW多糖/安瓿(扩展不确定度,覆盖因子k=2.13,对应95%置信水平);2)MenY多糖候选标准品(16/206)的含量为0.958±0.076mgMenY多糖/安瓿(扩展不确定度=2.6%)。每个安瓿的多糖量在36个月的时间内在所有稳定性条件下保持一致。
