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[ABO血型鉴定用必备试剂红细胞的质量控制]

[Quality control of indispensable reagent RBC for ABO typing].

作者信息

Liu Shu-Hong, Xu Hua, Wu Hai-Tao, Zhao Yong-Qi, Fan Ming

机构信息

Institute of Basic Medical Sciences, Academy of Military Medical Sciences, Beijing 100850, China.

出版信息

Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2007 Dec;15(6):1289-92.

PMID:18088486
Abstract

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.

摘要

已知血型的试剂红细胞是ABO血型血清学鉴定中检测抗体不可或缺的试剂。为提高检测准确性,解决试剂红细胞制备的标准化及质量控制问题,进行了试剂红细胞特异性和亲和力检测、振荡试验、流式细胞术及原子力显微镜检测。在筛选并建立质量控制试剂的基础上,建立了质量检验和质量控制方法。结果表明,分三批评估制备的试剂红细胞保证了质量和性能,并最大限度地降低了不同批次产品间的差异。总之,解决了试剂红细胞制备的质量控制问题,也提高了血型检测的准确性。

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