PROTOCOL TO THE EUROPEAN AGREEMENT
on the Exchange of Blood-grouping Reagents
GENERAL PROVISIONS
1.
Specificity
2.
Potency
3.
International Standards and International Units
4.
Stability and expiry date
5.
Preservation
6.
Coloration
7.
Dispensing and volume
8.
Records and samples
9.
Classification of reagents
10.
Labels, leaflets and certificates
SPECIFIC PROVISIONS
A. BLOOD-GROUPING SERA OF HUMAN ORIGIN
(a) SERA OF HUMAN ORIGIN FOR AB0 GROUPING
(i)
Anti-A blood-grouping serum (human)
Potency
Titration
Determination of avidity
(ii)
Anti-B blood-grouping serum (human)
Potency
Titration
Determination of avidity
(iii)
Anti-A + Anti-B (group 0) blood-grouping serum (human)
Potency
Titration
Determination of avidity
(b) SERA OF HUMAN ORIGIN FOR Rh GROUPING
(i)
Anti-D (anti-Rh
o
) blood-grouping serum (human)
Potency
Titration
Determination of avidity
(ii)
Anti-C (anti Rh′) blood-grouping serum (human)
Potency
Titration
Determination of avidity
(iii)
Anti-E (anti-rh″) blood-grouping serum (human)
Potency
Titration
Determination of avidity
B. REAGENTS OF NON-HUMAN ORIGIN
(a) SERA OF ANIMAL ORIGIN
(i)
Anti-A blood-grouping serum (animal)
Potency
Titration
Determination of avidity
(ii)
Anti-B blood-grouping serum (animal)
Potency
Titration
Determination of avidity
(iii)
Anti-human-globulin serum (animal)
(4)
Specificity
Potency
Titration
(b) BLOOD-GROUPING REAGENTS OF VEGETABLE ORIGIN
(i)
Anti-A blood-grouping reagent (vegetable)
Potency
Titration
Determination of avidity
(ii)
Anti-B blood-grouping reagent (vegetable)
Potency
Titration
Determination of avidity
|
Serum S |
Reagent U |
Serum S |
Reagent U |
A1 corpuscles |
1: 512 |
1: 128 |
256 |
64 |
A2B corpuscles |
1: 32 |
1: 16 |
256 |
128 |
|
titres (observed) |
titres (observed) |
Units (by definition) |
Units (by comparison) |
EXEMPLES D'ÉTIQUETTE
EXAMPLES OF LABEL
CONSEIL DE L'EUROPE
COUNCIL OF EUROPE
ACCORD EUROPÉEN RELATIF A L'ÉCHANGE DES RÉACTIFS POUR LA DETERMINATION DES GROUPES SANGUINS
EUROPEAN AGREEMENT ON THE EXCHANGE OF BLOOD-GROUPING REAGENTS
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