wetzoeker

1 — Specificity Europese Overeenkomst inzake de uitwisseling van reagentia voor weefseltypering

Specificity

A. Tissue-typing reagents to be used in cytotoxic techniques on lymphocytes

These reagents must, when used according to the technique recommended by the producer, react with all lymphocytes known to contain the antigen(s) corresponding to the specificity(ies) mentioned on the label. They must not react with any cell known not to contain this antigen (these antigens). If a sole reagent does not satisfy these conditions, a combination of four sera of the same specificity must be used together. In this case, at least three sera must react with each lymphocyte sample containing the corresponding antigen and, inversely, not more than one should react with cells not containing this antigen.

When these reagents are used according to the technique recommended by the producer there must be no evidence of any interfering serological phenomena such as:

a. prozone effects,

b. anticomplementarity.

B. Tissue-typing reagents for use in a complement fixation technique on platelets

These reagents must, when used according to the technique recommended by the producer, give complement fixation with all platelets known to contain the antigen(s) corresponding to the specificity(ies) mentioned on the label. They must not give complement fixation with any platelets known not to contain this antigen (these antigens). If a sole reagent does not satisfy these conditions, a combination of four reagents of the same specificity must be used together. In this case, at least three sera must react with each platelet sample containing the corresponding antigen and, inversely, not more than one should react with cells not containing this antigen.

When these reagents are used according to the technique recommended by the producer there must be no evidence of any interfering serological phenomena such as:

a. prozone effects,

b. anticomplementarity.

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