Immunohaematology calibrator/control IVDs

Intended purpose

For use in ABO, RhD blood grouping: Antibody screening and identification, ABO analytical sensitivity, Anti-D antibody standard, replicate testing, competency testing, pre-acceptance testing and routine process.

Functional description

Designed to control, standardise and validate all routine immunohaematology tests. These products are to be tested in parallel with routine patient samples to control and ensure the process is capable of determining the correct ABO RhD Blood Group and detecting and identifying clinically relevant, unexpected antibodies. The integrity of the testing process is proven by the test results matching those of the published results on the accompanying 'Results Sheet'.