ABO反定型试剂红细胞的质量控制

Quality Control of Indispensable Reagent RBC for ABO Typing

已知血型的试剂红细胞是ABO血型的血清学鉴定中检测抗体必不可少的试剂。为了提高ABO血型检定结果的准确性,解决自制试剂红细胞无标准和无质控的问题,本研究组建立了ABO反定型试剂红细胞的质控方法,进行了试剂红细胞的特异性和亲和性检测、振荡检测、流式细胞术和原子显微镜观察。通过筛选建立了质控参考品,并在此基础上确定质量检定标准及质控方法,同时对制备的3批次试剂红细胞进行了评价。研究结果表明:制备的反定型试剂红细胞既能保证质量和性能的稳定,又能最大限度地降低批次间的差异。结论:制备的ABO反定型试剂红细胞解决了自制红细胞的质控问题,并能提高血型检定结果的准确性。

The reagent RBC of known blood group is indispensable reagent for detecting antibody in serological identification of ABO blood group. To elevate the accuracy of detection and solve problems for standardization and quality control of prepared reagent RBC, the detection of specificity and affinity of reagent RBC, shaking test, flow cytometry and atomic force microscopy were performed. On the basis of screening and establishing the reagent for quality control, methods for quality inspection and quality control were established, The results indicated that the prepared reagent RBC evaluated in three batches ensured the quality and performance, and decreased the variance between different batches of the products to the utmost. In conclusion, the quality control problems of prepared reagent RBC had been solved and the accuracy of detection for blood types also elevated.