Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Biological Standards and Control (NIBSC), South Mimms, Potters Bar, Hertfordshire, EN6 3QG, UK.
Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Biological Standards and Control (NIBSC), South Mimms, Potters Bar, Hertfordshire, EN6 3QG, UK.
Biologicals. 2023 Nov;84:101701. doi: 10.1016/j.biologicals.2023.101701. Epub 2023 Aug 30.
Here we report the results of a study to establish a replacement WHO International Standard (IS) for tetanus toxoid for use in flocculation test. The standard was calibrated in flocculation units (Lf) against the 2nd IS using the Ramon flocculation method. At its 70th meeting in October 2019, WHO ECBS established the material (coded 16/302) as the 3rd WHO IS, with an assigned value of 970 Lf/ampoule from the results of seventeen laboratories across ten different countries. The study also provided an opportunity to assess the use of alternative methods for measuring Lf. Participants were asked to use an in-house Enzyme Linked Immunosorbent Assay (ELISA) developed at NIBSC, or other suitable in-house methods, to determine ELISA-specific Lf values (Lf-eq units are specific only for pre-calibration of antitoxin in the flocculation test) of 16/302 to compare to those of the flocculation test. Nine laboratories participated by performing the NIBSC ELISA, one laboratory performed flocculation by laser light-scattering following an in-house protocol, and three laboratories performed ELISA following in-house protocols. The results intimate that these alternative methods could be useful for monitoring consistency of production at different stages of vaccine manufacturing.
我们在此报告了一项研究结果，该研究旨在建立破伤风类毒素的替代世卫组织国际标准（IS），用于絮状试验。该标准使用 Ramon 絮状试验方法，通过与第 2 个 IS 进行校准，以絮状单位（Lf）表示。在 2019 年 10 月的第 70 次会议上，世卫组织 ECBS 将该材料（编码为 16/302）确定为第 3 个世卫组织 IS，其在十个不同国家的十七个实验室的结果中赋值为 970Lf/安瓿。该研究还提供了评估替代方法测量 Lf 的机会。参与者被要求使用 NIBSC 开发的内部酶联免疫吸附测定（ELISA）或其他合适的内部方法，以确定 16/302 的 ELISA 特异性 Lf 值（Lf-eq 单位仅特定于絮状试验中抗毒素的预校准），并与絮状试验的结果进行比较。九个实验室通过执行 NIBSC ELISA 参与了该研究，一个实验室按照内部方案通过激光散射进行絮状试验，三个实验室按照内部方案执行 ELISA。结果表明，这些替代方法可能有助于监测疫苗生产不同阶段的生产一致性。
