狂犬病疫苗单一径向免疫扩散效价试验(SRD)的改进

Inge Vogel , Michael Kundi , Franz Gerstl
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引用次数: 5

摘要

1983年,世卫组织的一项合作研究表明,单一径向免疫扩散试验为测定灭活狂犬病疫苗的糖蛋白含量提供了可靠的系统。我们对合作研究中使用的方法进行了改进,采用圆形塑料板,孔呈圆形排列。效力估计是通过多重斜率比方法进行的,而不是通过单一斜率估计程序调整共同截距。对降水面积计算的准确性和可靠性进行了统计评价。我们证实,对于效价估计的目的,面积计算在大多数情况下是足够精确的。通过分析圆形板和玻璃板的变化来源,并通过测试这些方法的可变性,我们发现圆形板和玻璃板一样好。圆板的优点主要在于易于操作:琼脂糖溶液倒入板中,而不需要单独的模具;装有这些板的整体湿室是现成的;沉淀带的测量很容易,用观察器放大四倍,所需的抗糖蛋白较少。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A modification of the single radial immunodiffusion potency test (SRD) for rabies vaccines

In 1983 a WHO collaborative study showed that the single radial immunodiffusion test provided a reliable system for the assay of the glycoprotein content of inactivated rabies vaccines. We have modified the method used in the collaborative study by using round plastic plates with wells arranged in a circle. Potency estimates were made by the multiple slope ratio method and not by single slope estimation procedures adjusted for a common intercept.

We carried out a statistical evaluation of the accuracy and reliability of the precipitation area calculation. We confirmed that for the purpose of the potency estimation the area calculations were sufficiently precise in most instances.

By analysing the sources of variation for round and for glass plates and by testing the variability of these methods we found that the round plates were as good as the glass plates. The advantage of the round plates was mainly in the ease of their handling: the agarose solution was poured in the plates without the need for a separate mould; an integral moist chamber with these plates was readily available; the precipitation zones were measured easily using a viewer which gave fourfold enlargements and the method required less antiglycoprotein.

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