检验用ABO型和RhD型红细胞试剂的质量评估

Quality evaluation of RBC reagents in detection of ABO and RhD blood group

目的建立ABO和RhD型检验用红细胞试剂的检测方法和评价指标,并对其进行质量评估。方法利用红细胞保存液的pH、直（间）接抗人球蛋白试验、红细胞抗原特异性试验、红细胞抗原强度试验及亲和力试验5项检测方法及评价指标,对44株红细胞试剂进行质量评估。结果 44株红细胞试剂pH均在6.24~6.95之间,直（间）接抗人球蛋白试验结果均为阴性,其抗原特异性、抗原强度及亲和力性能均符合指标要求。结论 5项检测方法和评价指标可用于ABO和RhD型检验用红细胞试剂的质量评估,为建立统一的检测方法和评价指标提供依据。

Objective To develop the unified standards and methods for quality assessing of RBC（ Red blood cells） reagents in detection of ABO and Rh D blood group. Methods Five indexes were applied in evaluation 44 lines of RBC reagents,including p H for preservation solution of RBC,direct or indirect anti-human immunoglobulin test,specificity,strength,affinity for RBC antigens. Results The p H for preservation solution of RBC were in 6.24 —6.95,the direct or indirect anti-human immunoglobulin tests were all negative,and specificity,strength,affinity for 44 lines of RBC antigens were in conformity with the standards. Conclusion The developed 5 tests and evaluation indexes could be applied in quality evaluation of RBC reagents in detection of ABO and Rh D blood group,on which a scientific basis was provided in development of the unified detection method and evaluation standard in related aspect.