Abstract:Abstract: Objective:To prepare laboratory internal quality control material for screening irregular antibody and evaluate its applications. Methods:The commercialized monoclonal IgG of anti-D was served as the strong positive quality control material, the diluted IgG solution of anti-D as the weakly positive quality control material, and the plasma from AB blood type donor with negative irregular antibody as negative quality control materials. The strong positive and negative quality control materials were determined repeatedly for 20 times to ascertain the target value. The highest dilution of erythrocyte agglutination intensity 2+ was regarded as the optimal dilution degrees of weak positive quality control material by double dilution of the monoclonal anti-D IgG and the determination was repeated for 20 times. The quality control materials and untested samples were simultaneously determined everyday during 6 months. Results:The target value of strong positive quality control materials was 4 +. The target value of weakly positive quality control materials was 2+ with optimal dilution of 1∶500 and range of quality control from 1+ to 3+. During the 6 months, the weakly positive quality control material was out of the range of quality control for four times, whereas both the strong positive and negative quality controls materials were in the range of control. Conclusion:The quality control materials prepared in laboratory were available for determination of irregular antibody and its function could meet the requirements of the test items.