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Laboratory testing of whole cell pertussis vaccine: a WHO proficiency study using the Kendrick test

机译：全细胞百日咳疫苗的实验室测试：使用Kendrick检验的WHO能力研究

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Whole cell pertussis vaccine (WCV), commonly in combination with vaccines for diphtheria and tetanus, has an important role in reducing morbidity and mortality among children in most parts of the world. Testing to assure the efficacy of such vaccines is essential. We have, therefore, carried out, under the Global Training Network (GTN) of the Department of Vaccines and Biologicals at the World Health Organization (WHO), a proficiency study involving 13 laboratories in 12 countries that routinely test WCV. Two vaccine samples were tested in this study and represented samples which were expected clearly either to pass (sample B, a full strength vaccine) or to fail (sample A, 1/8 strength of vaccine B). Data from this study showed good performance by the majority of participants. Most assays were statistically valid and were carried out to the level of precision achieved for these assays in previous studies. This study also indicated that, relative to the assay precision. the in-house reference (IHR) preparations are in general accurately calibrated. Statistically valid assays of the sub-potent vaccine, A, showed it to fail in all except one laboratory. Statistically valid assays of the potent vaccine. B, showed it to pass in al I laboratories. Nevertheless, the between laboratory variability of estimates for vaccine B, and for comparisons of the two vaccine samples suggested that there are some differences in results in different laboratories. The introduction of a common working standard may assist in reducing inter-laboratory variation. This study has shown clearly satisfactory performance by most laboratories. However, a serious problem was detected in one laboratory where the sub-potent vaccine A could have been passed and was not distinguished from the eight-fold more potent vaccine B. There were also indications of possible problems in several other laboratories. where IHR preparation may not be accurately calibrated or where vaccine samples A and B may not be completely distinguished. Although this study provides reassurance that most laboratories perform well, it demonstrates the essential role of ongoing proficiency studies in high-lighting problems.
机译：全细胞百日咳疫苗（WCV）通常与白喉和破伤风疫苗结合使用，在降低世界大部分地区儿童的发病率和死亡率方面具有重要作用。确保此类疫苗功效的测试至关重要。因此，我们在世界卫生组织（WHO）疫苗和生物系的全球培训网络（GTN）下进行了一项能力研究，涉及12个国家的13个实验室进行常规WCV测试。在这项研究中测试了两个疫苗样品，它们代表的样品显然可以通过（样品B，全强度疫苗）或不合格（样品A，疫苗B的1/8强度）。这项研究的数据显示，大多数参与者表现良好。大多数测定在统计上是有效的，并且进行到先前研究中这些测定所达到的精确度水平。这项研究还表明，相对于测定精度。内部参考（IHR）的准备工作通常会得到准确校准。亚有效疫苗A的统计有效分析表明，除一个实验室外，该疫苗在所有疫苗中均无效。有效疫苗的统计有效测定。 B，表明它已通过所有实验室。然而，疫苗B的估计值在实验室之间的变异性以及两种疫苗样品的比较之间的差异表明，不同实验室的结果存在一定差异。通用工作标准的引入可能有助于减少实验室之间的差异。这项研究表明，大多数实验室的性能显然令人满意。但是，在一个实验室中发现了一个严重的问题，该实验室本可以通过亚强力疫苗A的，并且无法与强力B疫苗的八倍进行区分。在其他几个实验室中也有可能存在问题的迹象。可能无法准确校准IHR准备或无法完全区分疫苗样品A和B的地方。尽管这项研究可以保证大多数实验室的性能良好，但是它证明了正在进行的熟练度研究在突出问题上的重要作用。

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