Update notice: text HIGHLIGHTED has changed following the issue of Change Notification 16 - 2009
13.10 Mandatory testing of blood donations
13.10.1 Blood groups shall be determined using reagents that comply with Chapter 12 of these guidelines.
13.10.2 All mandatory tests must be performed using an automated test system in the first instance (see Section 13.13). Any persistent failures may be resolved using manual methods (see Section 13.14).
13.10.3 ABO blood grouping
The ABO blood group must be determined on each blood donation
A donor whose ABO blood group is unknown to the test centre, e.g. a first-time donor, the ABO blood group must be determined by testing the plasma/serum with group A1, and B red cells. The red cells of the donation must be tested twice with anti-A and anti-B as a minimum. The ABO group can only be accepted if the results are in agreement
If the security of sampling analysis and data transfer is assured, it is sufficient to test the red cells from previously tested donors with anti-A and anti-B once. There is no requirement to test the plasma. The ABO blood group shall be accepted only if the results are in agreement with those of previous tests.
13.10.4 Quality control of ABO blood grouping
Quality control procedures recommended by reagent and equipment manufacturers should be followed
The following minimum test monitors are required for each batch of ABO blood grouping tests:
anti-A, anti-B, anti-A,B and anti-A + B, must give appropriate reactions with A1, A2, A2B, B and O cells
reagent red cell samples must give appropriate reactions with anti-A, anti-B, anti-A,B and/or anti-A+B.
13.10.5 D grouping
The D blood group must be determined on each donation of blood.
In the testing of donors being grouped for the first time, two anti-D blood grouping reagents should be used capable of detecting between them DIV, DV and DVI antigens. If two monoclonal anti-Ds are used, they should be from different clones.
Donors whose blood gives an unequivocal positive reaction with both anti-D reagents should be regarded as D positive.
Donors whose blood is unequivocally negative with both anti-D reagents should be regarded as D negative.
If the results with the anti-D reagents are discordant or equivocal, the tests should be repeated. Where the D group is in doubt it is safer to classify such donors as D positive.
For known (repeat) donors one anti-D reagent, or blended reagent, that detects weak D, DIV, DV and DVI can be used.
13.10.6 Quality control of D grouping
Quality control procedures recommended by reagent and equipment manufacturers should be followed.
The following minimum test monitors are required for each batch of D grouping tests:
Each series of D blood grouping tests must obtain appropriate reactions with R1r red cells as a positive and with r'r or rr red cells as a negative
Appropriate reactivity with test monitor red cell samples expressing weak D should also be assured during use, although not necessarily with each batch of tests.
13.10.7 Antibody screening
Blood and blood components with antibodies of probable clinical significance may be released, as shown in Table 13.1.
Routine antibody screen
All donations must be tested for the presence of red cell antibodies. This is achieved by testing the donor's serum or plasma using a validated technique capable of detecting, anti-D at 0.5 IU/mL or lower
Reagent red cells for routine antibody screening may be:
provided from a minimum of two individual donations (not pooled); or
as a pool of red cells in equal proportions from no more than two donations; or
red cells from a single donation
as a minimum the following antigens should be expressed: D; C; c; E; e; K.
each batch of tests must include a test monitor of ≤0.5 IU/mL anti-D
Donations found to be reactive in the routine antibody screen should be further tested by an indirect antiglobulin test to determine the fate of the products as specified in Table 13.1.
Antibody screen for blood for neonates
Blood for neonatal use must be screened and found negative for antibodies
by an indirect antiglobulin test, performed using a two cell panel expressing
the following antigens as a minimum: C;c;D;E;e;K;k;Fya;Fyb;Jka;Jkb;S;s and
Table 13.1 Minimum release criteria for blood products with antibodies of probable clinical significance
|Product||Antibody screen for blood for neonates||Donation plasma sample diluted 1 in 10||Donation plasma sample diluted 1 in 50|
|For neonatal use||Negative||Not applicable||Not applicable|
|Red cells in SAG-M||Not applicable||Not applicable||Negative|
|All other products||Not applicable||Negative||Not applicable|