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2 — Potency Europese Overeenkomst inzake de uitwisseling van reagentia voor weefseltypering

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:

Regeling
Europese Overeenkomst inzake de uitwisseling van reagentia voor weefseltypering
Soort
Verdrag
Geldend vanaf
28-03-1985
BWB-id
BWBV0004016
Versie
1985-03-28_0

In de hele regeling · Officiële tekst op wetten.overheid.nl