流式细胞术检测P选择素的方法学性能评价

The evaluation of the methodology for the determination of P selectin with flow cytometry

目的对流式细胞术（FCM）检测P选择素进行方法学性能评价。方法参考美国临床和实验室标准化协会（CLSI）系列文件,结合工作实际,设计验证方案,对BD Aria流式细胞仪检测系统测定血浆P选择素的精密度、准确度、分析灵敏度、分析测量范围和生物可参考区间五大分析性能进行验证和评价,并将实验结果与厂家（美国BD公司）提供的分析性能或公认的质量指标进行比较。结果 P选择素含量在39.06和10 000 ng/L时,批内变异系数分别为4.23%和9.00%,批间变异系数分别为4.63%和11.00%,准确度相对偏倚分别为2.71%和5.28%;检测灵敏度为7.88 ng/L,分析测量范围为7.88-103 928.00 ng/L,生物参考区间验证为4 512.20-10 250.00 ng/L。结论 BD Aria流式细胞仪检测系统检测血浆P选择素的分析性能符合厂家提供的性能指标和公认的质量指标。

Objective To evaluate the performance of flow cytometry（FCM） methodology to test P-selectin.Methods Referring to a series of documents by the U.S.Institute of Clinical and Laboratory Standards（CLSI）,as well as practical experience,we designed the plan to test and analyze the BD Aria FCM on precision,accuracy,analytical sensitivity,analytical measurement range and biological reference interval,and then compared the experiment results with the parameters provided by the manufacturer（U.S.BD company） or publicly acknowledged quality standards.Results When the content of P-selectin level was between 39.06 ng / L and 10 000 ng / L,the intraassay coefficient of variation was between 4.23% and 9.00%,while the interassay coefficient of variation was between 4.63% and 11.00%.The relative bias of accuracy of the two was 2.71% and 5.28% respectively.The test sensitivity was 7.88 ng / L.The domain of the analysis and measurement was 7.88-103 928.00 ng/L,while the validation of biological reference interval was 4 512.20-10 250.00 ng/L.Conclusion The performance of BD Aria FCM analysis system to test plasma P-selectin is in accordance with the parameters provided by the manufacturer as well as publicly acknowledged quality parameters.