[Characterization and validation of a human anti-C monoclonal antibody].

Peripheral lymphocytes were obtained from an immunized woman against C and Ce antigens. Punction was realized 14 days after childbirth. After hetero-hybridization, a unique cell line continued secreting a monoclonal IgM antibody. Serological characterization of this antibody was determined by direct agglutination tests against 150 native and enzyme treated red blood cells including some rare phenotypes. This antibody was specific of C determinant of the Rh system. It showed strong reactions by saline and enzymatic technics, against C positive cells from Ce positive and Ce negative patients. The validation was performed by a manual direct agglutination test in saline (tube) and by an automated-hemagglutination test (in microplate) against 2,500 patients samples. No discrepancy was observed. This monoclonal IgM anti-C could be used as a potent reagent and since one year, about 30,000 patients and pregnant women have been phenotyped in our laboratory successfully.