Serology and NAT studies
Satisfactory performance implies that:
- core-negative samples are found to be non-reactive;
- core-positive samples are found to be reactive;
- the ratios obtained are concordant/coherent for samples serially diluted from the same source material;
- the ratio interpretations are correct.
Immuno-haematology studies
Satisfactory performance implies that:
- whole blood samples are correctly identified as core-positive for their respective ABO groups and for each of the Rhesus, Kell, Duffy, Kidd and MNS phenotypes;
- plasma samples containing irregular antibodies and classified as core-positive are found to be positive. If specificity testing is performed, the correct antibody specificities have to be determined and must correspond to the specificity found in pre-testing.
It should be noted that it is the performance of the laboratory that is evaluated, not the performance of the assays used by the participants.