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Stability of purified tuberculin in high dilution.

K Magnus, J Guld, Hans Th. Waaler, M Magnusson

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Abstract

The authors have investigated the effect of storage on the potency of 5 TU dilutions (5 TU per 0.1 ml) of the purified tuberculin RT 19-21 (Statens Seruminstitut, Copenhagen).Dilutions stored at 2-4 degrees C, 20 degrees C and 37 degrees C for different periods up to 18 months were compared by intradermal testing. About 900 BCG-vaccinated schoolchildren were given duplicate tests and in addition 500 tests were made in BCG-vaccinated guinea-pigs.The results showed unexpected variability. It appeared that this variability was due to unsystematic variations in potency both between dilutions prepared at different times and between ampoules of the same dilution.Because of this variability only limited conclusions could be drawn. At 2-4 degrees C the effect of storage seemed to be very slight, the potency of the dilutions being reduced by less than 25% after 18 months. At the higher temperatures, the decrease in activity was more rapid. Nevertheless, the dilutions could be stored at room temperature (20 degrees C) for some months without any practically significant loss of potency.

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What this paper is about

The authors have investigated the effect of storage on the potency of 5 TU dilutions (5 TU per 0.1 ml) of the purified tuberculin RT 19-21 (Statens Seruminstitut, Copenhagen).Dilutions stored at 2-4 degrees C, 20 degrees C and 37 degrees C for different periods up to 18 months were compared by intradermal testing. About 900 BCG-vaccinated schoolchildren were given duplicate tests and in addition 500 tests were made in BCG-vaccinated guinea-pigs.The results showed unexpected variability. It appeared that this variability was due to unsystematic variations in potency both between dilutions prepared at different times and between ampoules of the same dilution.Because of this variability only limited conclusions could be drawn. At 2-4 degrees C the effect of storage seemed to be very slight, the potency of the dilutions being reduced by less than 25% after 18 months. At the higher temperatures, the decrease in activity was more rapid. Nevertheless, the dilutions could be stored at room temperature (20 degrees C) for some months without any practically significant loss of potency.

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Available abstract

The authors have investigated the effect of storage on the potency of 5 TU dilutions (5 TU per 0.1 ml) of the purified tuberculin RT 19-21 (Statens Seruminstitut, Copenhagen).Dilutions stored at 2-4 degrees C, 20 degrees C and 37 degrees C for different periods up to 18 months were compared by intradermal testing. About 900 BCG-vaccinated schoolchildren were given duplicate tests and in addition 500 tests were made in BCG-vaccinated guinea-pigs.The results showed unexpected variability. It appeared that this variability was due to unsystematic variations in potency both between dilutions prepared at different times and between ampoules of the same dilution.Because of this variability only limited conclusions could be drawn. At 2-4 degrees C the effect of storage seemed to be very slight, the potency of the dilutions being reduced by less than 25% after 18 months. At the higher temperatures, the decrease in activity was more rapid. Nevertheless, the dilutions could be stored at room temperature (20 degrees C) for some months without any practically significant loss of potency.

Key concepts: Serial dilution, Potency, Dilution, Tuberculin, Medicine, Chromatography, Chemistry, Tuberculosis

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