The safety of blood transfusion in the European Community relies in part on the quality of the reagents used for ABO and Rh(D) typing and compatibility testing. Mistyping of donors or patients caused by defective substandard reagents can lead to clinically significant transfusion reactions, and in some cases, fatality. There are no European reference materials available for the control of the quality of the reagents in use.
The aim of this project is to prepare, with the collaboration of representatives from blood transfusion laboratories and reagent manufacturers operating within Europe, anti-A, anti-B and anti-D certified reference materials. The certification will be conducted according to agreed specifications and will include the evaluation, validation and stability study of the proposed materials. Similar work may then be envisaged for three additional standards (anti-IgG, papain and control weak anti-D and red cell panels for anti-D evaluation).
Candidate pilot freeze-dried materials for anti-A, anti-B and anti-D are being tested and compared to existing FDA and WHO standards by the participants. The results are expected to be reported by mid 1992. Certification to be completed in 1993.
Funding SchemeCSC - Cost-sharing contracts
EN6 3QG Potters Bar