What constitutes satisfactory performance?

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.