2014年上海地区红、白细胞计数结果一致性的初步调查

Primary investigation on the consistency of red blood cell and white blood cell counts in Shanghai,2014

目的了解上海地区各级各类医疗机构临床实验室红细胞（RBC）计数和白细胞（WBC）计数结果的一致性，为制定适宜的正确度验证计划提供指导。方法将2个批号弱固定处理新鲜全血样本按要求发放至全市710家临床实验室，并要求在3d内完成检测，每批号样本重复检测5次，在收到所有上传结果后进行统计分析。结果使用12个品牌57个型号血液分析仪（包括WBC三分类和五分类仪器）的693家临床实验室叫报了RBC、WBC结果；所有仪器2个批号RBC计数结果总变异系数（CV）分别为2．06％和1．99％，WBC计数结果总CV分别为4．72％和4．84％；不同仪器组2个批号RBC计数结果的CV为0．76％～3．18％，WBC计数结果的CV为1．73％～6．32％，其均值均在各自总均值的95％可信区问内。结论卜海地区临床实验室RBC、WBC结果具有较好一致性；弱固定处理新鲜全血样本可替代新鲜全血用于正确度验证计划。

Objective To study the consistency of red blood cell （RBC） and white blood cell （WBC） counts in Shanghai, and to provide the reference for the appropriate accuracy verification project. Methods A total of 2 batches of weak-fixation-treatment whole blood samples were delivered to 710 clinical laboratories in Shanghai. Every laboratory was required to finish the determination within 3 d, with 5 duplicated determination results tor each batch. All the determination data were uploaded via internet for statistical analysis within scheduled time. Results A total of 693 clinical laboratories, with hematology analyzers （three- and five-classification instruments） spanning 12 brands and 57 models, reported their data of RBC and WBC counts. The coefficient of variation （CV） for RBC of 2 batch samples were 2.06% and 1.99% , respectively. The CV for WBC of 2 batch samples were 4.72% and 4.84% , respectively. The CV of different analyzers for RBC and WBC of 2 batch samples were 0. 76% -3.18% and 1.73%-6.32% , respectively, anti the means were within 95% confidence interval. Conclusions The counting results of RBC and WBC in the clinical laboratories in Shanghai have consistency, and fi＇esh weak-fixation-treatment whole blood sample is acceptable for substituting fresh whole blood in the application of the accuracy verification project for RBC and WBC counts.