Blood grouping reagents for the detection of the A and/or B antigen on human red cells
Pelikloon anti-A, anti-B, and anti-A,B (IgM) monoclonal blood grouping reagents (clone numbers are mentioned on the corresponding certificate of analysis/release document) are prepared from culture supernatants from stable hybridoma cell lines as first described by Köhler and Milstein (Nature 1975). These monoclonal reagents contain murine IgM antibodies and have been specially selected and developed to provide a reliable alternative to polyclonal reagents. These reagents meet the requirements of the concerned standards and guidelines. Performance characteristics are mentioned in the release documents, which are supplied with the product upon request. The principle of the test is the agglutination technique, which is based on antigen/antibody reaction. The reagents can be used in either spin tube or microplate method. These reagents are also suitable for use in automated test systems and should be standardised and validated by the user. The inclusion of positive and negative controls with each series of blood group determinations is strongly recommended. As well as determining the ABO blood group of the red cells, the serum of the patient should be tested for the presence of the corresponding anti-A and/or anti-B alloantibodies, using A1 and B reagent red cells (see relevant package insert).