[Antitetanus vaccination campaign in Alsace. Statistical study of the results].
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Biomedical subjects
Publications and source records attributed to J Malgras.
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A collaborative assay was conducted by 9 laboratories on 31 samples of human albumin which were in clinical use. It was the object of the study to establish test systems which would differentiate between albumins of venous or placental origin. The properties examined for this purpose were: appearance, total protein, haem, polymers, alkaline phosphatase and blood group substances. Additional tests such as for beta-thromboglobulin and citrate were included; pyrogenicity, however, was excluded because this was under study for all plasma proteins at that time. Results obtained were in satisfactory agreement both between laboratories and between samples. They, therefore, enabled the verification of a number of correlations in the test systems. The evaluation did not allow, however, the differentiation of the samples in relation to their origin. The results were, therefore, regarded as a tool to define the upper limits of acceptance for human albumins corresponding to the quality prescribed by the European Pharmacopoeia.
Glucose and Ethanol are determined in final Human Serum Albumin solutions, obtained by two different processes: freeze-drying (FD) and ultrafiltration (UF). The elimination rate for glucose is higher than that for ethanol in case of ultrafiltration. The concentration of both "contaminants" seems to be much lower by UF than by FD. From these data arises the question of a limit-value for fractionating agents, in the final product. In the case of FD process, as the reagents remain in the product final, they all must be strongly controlled. As a large part of small molecules can be eliminated by UF process, it permits to seek new reagents for protein separation.
Therapeutic fractions were obtained by fractionating human plasma containing HBs antigen, by the Cohn ethanol technique modified by Nitschmann. Plasmas with various HBs antigen titers were selected. The antigen was sought in each fraction by the techniques of counterelectrophoresis and radioimmunological detection in liquid phase. With the exception of very pure albumins, all fractions were found to contain the HBs antigen, though in variable proportions. A technique for the purification of albumin, applicable on an industrial scale, is proposed. It makes it possible to obtain an albumin fraction in which the HBs antigen cannot be detected by the most sensitive techniques, even starting with a plasma which is very rich in HBs antigen (titer 1/64 by counterelectrophoresis).