Potency Sample Clauses

Potency. A Tissue-typing reagents to be used in cytotoxic techniques on lymphocytes The titre of such a reagent is determined by making successive twofold dilutions of the serum under study in inactivated AB serum or in another appropriate medium from a donor who is negative for the antigen(s) corresponding to the antibody (antibodies) in the reagent and who should also not have been immunised against tissue antigens by transfusion, pregnancy or other means. Each dilution is then tested with lymphocytes known to contain the corresponding antigen(s) in the reagent, using the technique recommended by the producer. The titre is the reciprocal of the figure representing the highest serum dilution in which a significantly positive reaction occurs, the dilution being calculated without the inclusion of the volume of the corpuscular suspension or any other additive in the total volume. B Tissue-typing reagents for use in a complement fixation technique on platelets The titre of such a reagent is determined by making successive twofold dilutions of the serum under study in a solution containing inactivated AB serum in Veronal (R) buffer with a volume fraction of 0.01. Each serum is then tested with platelets known to contain the antigen homologous to the antibodies in the reagent, using the technique recommended by the producer. The titre is the reciprocal of the figure representing the highest serum dilution in which a significantly positive reaction occurs, the dilution being calculated without the inclusion of the volume of the corpuscular suspension or any other additive in the total volume. Further provisions, for tissue-typing reagents to be used in cytotoxic techniques on lymphocytes as well as for reagents to be used in a complement fixation technique on platelets:
Sample 1
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Potency. Titre is measured by making successive two-fold dilutions of the reagent under study in an appropriate medium. To each dilution is added an equal volume of a suspension of red corpuscles. The titre is the reciprocal of the figure representing the highest serum dilution in which a reaction occurs, the dilution being calculated without the inclusion of the volume of the corpuscular suspension in the total volume. In the case of anti-A, anti-B and other reagents intended for use on slides, avidity is expressed by means of the time required for agglutination on a slide.
Sample 1

Related to Potency

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