National Institute for Biological Standards and Control, Potters Bar, Hertfordshire EN63QG, UK.
J Immunol Methods. 2011 Sep 30;372(1-2):137-45. doi: 10.1016/j.jim.2011.07.005. Epub 2011 Jul 18.
As part of the new EUVAC.NET contract with ECDC (Pertussis Work Area 4), a collaborative study was organised in July-December 2010. Two well-defined reference preparations with high and low IgG antibodies to pertussis toxin (PT), were sent to participants. The purposes of this study were to assess current laboratory performance of serological assays for pertussis; to compare in-house reference preparations that are currently used by participants for the serological assay; and to identify needs for standardisation of the serological assay. Reference Laboratories in Europe currently performing serological assays for the diagnosis of pertussis by measuring antibody to PT, were invited to participate in the study. A total of 17 laboratories/countries participated in this study. Results were reported from a total of 9 participants who used in-house ELISA assays and 10 participants who used commercial kits. All participants using in-house ELISA with purified PT coating plates distinguished the 2 preparations and gave results that were comparable to the expected values. A total of 6 commercial kits included in the study showed different results. The kits coated with mixture antigens did not appear to be able to give results that were correlated to the WHO reference preparations.
作为欧盟疫苗和免疫全球网络（EUVAC.NET）与欧洲疾病预防控制中心（ECDC）的新合同（百日咳工作领域 4）的一部分，2010 年 7 月至 12 月组织了一项合作研究。向参与者发送了两种具有高和低百日咳毒素（PT）抗体的明确参考制剂。该研究的目的是评估当前用于检测百日咳的血清学检测的实验室性能；比较目前参与者用于血清学检测的内部参考制剂；并确定血清学检测标准化的需求。目前通过测量针对 PT 的抗体来进行用于诊断百日咳的血清学检测的欧洲参考实验室应邀参加了这项研究。共有 17 个实验室/国家参加了这项研究。共有 9 名使用内部 ELISA 检测的参与者和 10 名使用商业试剂盒的参与者报告了结果。所有使用纯化的 PT 包被板的内部 ELISA 的参与者均区分了这两种制剂，并给出了与预期值相当的结果。该研究中包括的总共 6 种商业试剂盒显示出不同的结果。用混合抗原包被的试剂盒似乎无法给出与世界卫生组织参考制剂相关的结果。
