| 摘要: |
| ［摘要］ 目的 采用美国临床和实验室标准化协会（CLSI）EP9-A3文件，探讨两种血细胞分析仪检测结果的可接受性。方法 参考CLSI EP9-A3文件，以Sysmex XE-2100血细胞分析仪为参比系统，在Sysmex XE-2100血细胞分析仪和迈瑞BC-5800血细胞分析仪均处于正常状态下，分别检测40份新鲜抗凝全血，对白细胞（WBC）、红细胞（RBC）、血红蛋白（Hb）、血小板（PLT）、平均红细胞体积（MCV）检测结果，通过ESD法进行离群值检验，评估偏移。选用最佳回归模型拟合回归方程，计算各项目的95%置信区间（CI）和医学决定水平处的偏移。以1/2 CLIA′88允许误差为标准判断偏移是否可接受。结果 两种血细胞分析仪检测结果中WBC、MCV不具有可比性，RBC、Hb、PLT项目结果具有可比性。结论 CLSI EP9-A3能够用于评价不同血细胞分析仪检测系统的可比性，同一实验室不同血细胞分析仪检测系统应定期执行比对试验，并应该根据比对结果做出相应处理，以便为临床提供准确可靠的血细胞分析检测数据。 |
| 关键词: 血细胞分析仪 EP9-A3文件 比对试验 |
| DOI：10.3969/j.issn.1674-3806.2019.07.12 |
| 分类号:R 446 |
| 基金项目:广西医药卫生计划课题（编号：Z20170338） |
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| Application of CLSI EP9-A3 in comparison of two blood cell analyzer detection systems |
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SU Hang-jiu, ZHOU Cheng-yan, YANG Wen-hui
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Department of Clinical Laboratory, the People′s Hospital of Guangxi Zhuang Autonomous Region, Nanning 530021, China
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| Abstract: |
| ［Abstract］ Objective To explore the acceptability of the test results between two kinds of blood cell analyzer using the Clinical and Labratory Standards Institute(CLSI) EP9-A3 files. Methods Refering to CLSI EP9-A3 files and Sysmex XE-2100 blood cell analyzer as reference system, we detected 40 fresh anticoagulated whole blood samples respectively, using Sysmex XE-2100 and Mindary BC-5800 blood cell analyzers in a normal condition. The detection results of white blood cell(WBC), red blood cell(RBC), hemoglobin(Hb), platelets(PLT) and mean corpuscular volume(MCV) were compared between the two system. The outliers inspection and offset were evaluated by ESD method. Choose the best regression model fitting regression equation to calculate the 95% confidence interval(CI) and medical decision level of each item. 1/2 CLIA′88 permitted error was taken as a standard to determine whether a deviation was acceptable. Results The test results of WBC and MCV could not be comparable between the two kinds of blood cell analyzer, but the test results of RBC, Hb and PLT can be comparable between the two kinds of blood cell analyzer. Conclusion CLSI EP9-A3 can be used to compare different kinds of blood cell analyzer, and different kinds of blood cell analyzer should be compared regularly in the same laboratory to provide reliable test results for clinical applications. |
| Key words: Blood cell analyzer EP9-A3 files Comparison test |
