The Pertussis Serological Potency Test collaborative study to evaluate replacement of the mouse protection test
The Pertussis Serological Potency Test collaborative study to evaluate replacement of the mouse protection test
复制标题
DOI：
10.1006/biol.2000.0247
复制
发表时间：
2000-06-01
期刊：
影响因子：
1.7
通讯作者：
Hendriksen, C
中科院分区：
文献类型：
--
作者：
van der Ark, A;van Straaten-van de Kappelle, I;Hendriksen, C
百日咳血清学效价试验（PSPT）-基于对百日咳杆菌体液免疫应答的体外评估-被开发为小鼠保护试验（MPT）的替代方法。在五个实验室进行了一项小规模的合作研究，以评估PSPT的相关性和可靠性。这项研究分为三个不同的阶段，每个阶段都有自己的目标。出于培训目的，纳入了抗体检测试验（18323-全细胞ELISA（WCE））的中试阶段研究。发现实验室之间的吸光度和抗体浓度存在显着差异。在I期研究中，评估了18323-WCE的批内、批间和实验室间精密度。尽管在整个I期研究中，并不总是确定小于20%的精密度，并且随机发现抗体浓度存在显著差异，但实验室之间的抗体浓度排序一致，应保证在PSPT中对全细胞疫苗（WCV）进行可靠的效价估计。第二阶段是PSPT和MPT的比较研究，以评估PSPT的实施，证明相关性，并比较两种测试的重现性和可靠性。PSPT中每个疫苗剂量的平均抗体浓度和MPT中小鼠的存活率在实验室内和实验室之间存在显著差异。尽管如此。在两种试验模型中估计的待测疫苗的效力没有显著差异（P>0.05）。PSPT和MPT在实验室内和实验室间的均匀性卡方检验中相关良好。效价相似（总体比值=0.877），但PSPT的重现性更好，并且由于95%置信区间较小，降低了重新检测的机会。我们已经证明，PSPT是一个有效的模型来估计效力的百日咳WCV的从不同的制造商。此外，18323-WCE易于进行，试验内精密度和抗体等级保证了PSPT中百日咳WCV的可靠效价检测。(C)2000年，国际生物制品协会。
The Pertussis Serological Potency Test (PSPT)-based on in vitro assessment of the humoral immune response against Bordetella pertussis-was developed as an alternative for the Mouse Protection Test (MPT). A small-scale collaborative study was carried out in five laboratories to evaluate the relevance and reliability of the PSPT. The study has been divided into three separate phases, each with its own objective. A pilot-phase study of the antibody detection assay, the 18323-whole cell ELISA (WCE), was included for training purposes. Significant differences in absorbance and antibody concentrations between the laboratories were found. In the Phase I study, the intra-assay, inter-assay and inter-laboratory precisions of the 18323-WCE were assessed. Although a precision of less than 20% was not always established and significant differences in antibody concentrations were found at random throughout the Phase I study, the ranking of the antibody concentrations corresponded well between the laboratories and should warrant a reliable potency estimation of whole cell vaccines (WCV's) in the PSPT. Phase II was a comparative study of the PSPT and the MPT to evaluate the implementation of the PSPT, to demonstrate correlation and to compare the reproducibility and reliability of both tests. The mean antibody concentrations per vaccine dose in the PSPT and the survival of mice in the MPT differed significantly within and between the laboratories. Nevertheless. the potencies of the vaccines under test estimated in both test models did not differ significantly (P>0.05). The PSPT and MPT correlated well in chi(2)-lest of homogeneity within and between the laboratories. The potencies were similar (overall ratio=0.877), but the PSPT is more reproducible and reduces the chance of re-testing due to the smaller 95% confidence intervals. We have demonstrated that the PSPT is a valid model to estimate the potencies of pertussis WCV's from different manufacturers. Moreover, the 18323-WCE is easy to carry out and the intra-assay precision and antibody ranking warrants a reliable potency testing of pertussis WCV's in the PSPT. (C) 2000 The International Association for Biologicals.