Sysmex XE-2100全自动血液分析仪性能验证
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摘要
目的分析Sysmex XE-2100全自动血液分析仪的性能。方法选取110例门诊患者及健康体检者采集的新鲜静脉血,采集后4 h内完成检测。主要检验项目为白细胞计数(WBC)、红细胞计数(RBC)、血红蛋白(HGB)、红细胞平均体积(MCV)、红细胞比容(HCT)、平均血红蛋白量(MCH)、平均血红蛋白浓度(MCHC)、血小板计数(PLT)等指标,并从准确度、精密度、线性范围、临床可报告范围、本底计数、携带污染率等方面进行验证。结果通过验证发现,各指标均在标准范围内。结论 Sysmex XE-2100全自动血液分析仪具有较好的检验性能,且符合相关标准的要求,能够应用于临床检验。
Objective To analyze the performance of Sysmex XE-2100 automatic hematology analyzer. Methods Fresh venous blood was collected from 110 outpatients and healthy people, and the detection was completed within 4 hours. The main test items were WBC, RBC, HGB, MCV, HCT, MCH, MCHC and PLT. The accuracy, precision and line of the test items were also analyzed. Sex range, clinical reportable range, background count and contamination rate were verified. Results All indexes were within the standard range. Conclusion Sysmex XE-2100 automatic blood analyzer has good test performance, and meets the requirements of relevant standards, can be used in clinical testing.
Objective To analyze the performance of Sysmex XE-2100 automatic hematology analyzer. Methods Fresh venous blood was collected from 110 outpatients and healthy people, and the detection was completed within 4 hours. The main test items were WBC, RBC, HGB, MCV, HCT, MCH, MCHC and PLT. The accuracy, precision and line of the test items were also analyzed. Sex range, clinical reportable range, background count and contamination rate were verified. Results All indexes were within the standard range. Conclusion Sysmex XE-2100 automatic blood analyzer has good test performance, and meets the requirements of relevant standards, can be used in clinical testing.
引文
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[10]缪颖波,宋颖,许蕾,等.六西格玛质量管理在全自动血液分析仪质量控制规则选择中的应用[J].检验医学,2018,33(1):72-75.
[11]宗春辉,王玉兰,李刚,等.Sysmex XE-2100全自动血液分析仪的性能验证[J].医学检验与临床,2017,28(5):37-40.
[12]张抒怡,吴静.Sysmex XE-2100全自动血细胞分析仪无报警故障分析及处理[J].医疗装备,2014,27(12):105-106.
[13]胡友平.生化检验中仪器因素对检测结果的影响[J].当代医学,2014,21(14):142-143.
[14]金晓娟,陈琼,汪艳,等.迈瑞BC-6900全自动血液分析仪计数网织红细胞的性能评价[J].医学检验与临床,2016,27(1):72-73.
[15]张俊杰.探讨血常规检查的影响因素[J].中国保健营养,2016,26(6):383.
[2]周爱国,苏勇,陆奎英,等.迈瑞BC-5390全自动血液分析仪检测C反应蛋白的性能研究[J].医疗卫生装备,2016,37(12):104-107.
[3]尚红,王毓三,申子瑜.全国临床检验操作规程[M].4版.北京:人民卫生出版社,2015:1013-1026.
[4]中华人民共和国卫生部.WS/T406-2012临床血液学检验常规项目分析质量要求[S].北京:中华人民共和国卫生部,2012.
[5]National Committee for Clinical Laboratory Standards. ISBN 1-56238-498-8Evaluation of the linearity of quantitative measurement procedures:a statistical approach[S]. Wayne,PA,USA:NCCLS,2003.
[6]陈燕,曹敬丽,张伟,等.可报告范围测定方法探讨[J].标记免疫分析与临床,2015,22(7):694-697.
[7]张秀明,范勇利,温冬梅,等.临床化学自建检测系统分析性能确认的分析测量范围和临床可报告范围[J].中华检验医学杂志,2016,39(12):946-952.
[8]中华人民共和国卫生部.WS/T406 2012,临床血液学检验常规项目分析质量要求[S].北京:中国标准出版社,2012.
[9]杨洪乐,杨丽妙,汪冉,等.Beckman Colter Unicel DxH800血细胞分析系统性能验证评价[J].河北医科大学学报,2017,38(6):699-704.
[10]缪颖波,宋颖,许蕾,等.六西格玛质量管理在全自动血液分析仪质量控制规则选择中的应用[J].检验医学,2018,33(1):72-75.
[11]宗春辉,王玉兰,李刚,等.Sysmex XE-2100全自动血液分析仪的性能验证[J].医学检验与临床,2017,28(5):37-40.
[12]张抒怡,吴静.Sysmex XE-2100全自动血细胞分析仪无报警故障分析及处理[J].医疗装备,2014,27(12):105-106.
[13]胡友平.生化检验中仪器因素对检测结果的影响[J].当代医学,2014,21(14):142-143.
[14]金晓娟,陈琼,汪艳,等.迈瑞BC-6900全自动血液分析仪计数网织红细胞的性能评价[J].医学检验与临床,2016,27(1):72-73.
[15]张俊杰.探讨血常规检查的影响因素[J].中国保健营养,2016,26(6):383.