A NEW POTENCY TEST METHOD OF OLD TUBERCULIN
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概要
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The potency of old tuberculin has been assayed in Japan by the skin reactions of both human subjects and sensitized guinea pigs. However, test results on human subjects variy to a considerable extent due to the various degrees of tuberculin sensitivity, on one hand, and to the accerelated reaction influenced by the repeated tuberculin injection in the same site, on the other. In this connection, studies were carried out to settle a new rational assay method employing "Sequential test" on the guinea pigs, which are easily sensitized in a constant level and accordingly, the results obtained are mathematically analysable.<BR>For the "Sequential test", it is indispensable to obtain guinea pigs always sensitized in the similar degree. In addition, the animals are required to enable us to differentiate slight differences in reaction sizes elicited by various concentrations of tuberculin as sensitively as possible. To satisfy these requirements it was proposed to use the guinea pigs which are able to fill up the following conditions: (1) the reaction size produced by the injectien of a 1: 2, 000 dilution of tuberculin is between 14 and 19mm, and (2) the difference of reaction sizes produced by 1: 2, 000 and 1: 6, 000 dilutions of tuberculin is more than 4mm.<BR>Using sixty sensitized animals selected by the conditions described above a standardization for assay method of tuberculin potency was attempted. On both sides of back of the animals, two different dilutions, 1: 1, 000 and 1: 4, 000, of tuberculin were injected symmetrically, 24 hours after injections reaction sizes were measured, and the differences of the reaction sizes due to two different dilutions and the mean square (U<SUP>2</SUP>) were calculated. These values calculated were converged respectively and were allowed to be analyzed statistically. The qualification of the tuberculin which is considered applicable for practical use was determined as follows: (1) the difference of reaction sizes between the standard dilution and the sample to be examined must be within 1mm, (2) the probabilities of producer's risk and consumer's risk must be 0.10 and 0.05 respectively, and (3) the value of standard deviation must be calculated from the value of U<SUP>2</SUP> by using chi-square (<I>X</I><SUP>2</SUP>) distribution. Both the acceptance number and the rejection number were determined, and assay diagram and table were made.<BR>It was proved by the model experiments that this diagram is very useful as the new potency test of tuberculin with a high accuracy and practicability.
- 一般社団法人 日本結核病学会の論文
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- A NEW POTENCY TEST METHOD OF OLD TUBERCULIN