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机构地区:[1]首都医科大学附属北京佑安医院临床检验中心,北京100069
出 处:《中国卫生检验杂志》2015年第22期3871-3874,共4页Chinese Journal of Health Laboratory Technology
摘 要:目的使用国产试剂检测外周血中的CD45+和CD4+细胞,并与进口试剂比对,进行效果分析及评价。方法收集北京地区200例不同免疫水平患者的全血标本,分别使用贝克曼库尔特生产的进口试剂和同生时代研发的国产试剂,对200例标本应用同一台流式细胞仪进行外周血细胞表面抗原CD45+和CD4+的平行检测,并分析两者检测结果的相关性和一致性。结果 2种试剂检测CD4+细胞、淋巴细胞、粒细胞结果的相关系数均较高,分别为0.995 0、0.997 0、0.997 0,并显示高度的一致性;3组细胞检测的预期偏倚可信区间小于规定的允许误差范围。结论国产试剂与进口试剂相比具有等效性,已达到进口试剂的检测效果。Objective To analyze and evaluate the efficiency of CD45+ and CD4+ cells in blood with domestic and compared with foreign reagents. Methods The 200 blood samples were collected from patients with different immune levels in Beijing. The samples were detected for CD45+ and CD4 + cells of peripheral blood cell surface antigen with reagents from Beckman Coul- ter and Syngeneticera which was a domestic brand with one same flow cytometer, and then the test results were analyzed to com- pare the relevance and consistency. Results The test results of the CD4 + cells, lymphocyte and granulocyte with two different reagents had higher coefficient correlation (0.995 0, 0.997 0, 0.997 0) with high consistency; the anticipated bias of the con- fidence interval was lower than the permissible error. Conclusion Compared with foreign reagents, the domestic reagents can reach the parallel test results.
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