[1]李琳芸,肖秀林,王长征,等.Sysmex XN-1000血液分析仪性能验证[J].现代检验医学杂志,2015,30(03):126-128.[doi:10.3969/j.issn.1671-7414.2015.03.038]
　LI Lin-yun,XIAO Xiu-lin,WANG Chang-zheng,et al.Performance Verification of XN-1000 Hematology Analyzer[J].Journal of Modern Laboratory Medicine,2015,30(03):126-128.[doi:10.3969/j.issn.1671-7414.2015.03.038]
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Sysmex XN-1000血液分析仪性能验证()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第30卷
期数:
2015年03期
页码:
126-128
栏目:
研究简报·实验技术
出版日期:
2015-06-10

文章信息/Info

Title:
Performance Verification of XN-1000 Hematology Analyzer
文章编号:
1671-7414(2015)03-126-04
作者:
李琳芸; 肖秀林; 王长征; 张娟安
荆州市中心医院检验医学部,湖北荆州 434020
Author(s):
LI Lin-yun; XIAO Xiu-lin; WANG Chang-zheng; ZHANG Juan-an
Department of Laboratory Medicine,Jingzhou Central Hospital,Hubei Jingzhou 434020,China
关键词:
XN-1000血液分析仪;  性能验证
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2015.03.038
文献标志码:
A
摘要:
目的 对Sysmex XN-1000血液分析仪的主要性能指标进行实验室验证,核实其性能是否符合血液分析的质量要求。方法 参考WS/T 406-2012临床血液学检验常规项目分析质量要求,对XN-1000血液分析仪的本底计数、携带污染率、精密度、线性与可报告范围、正确度、不同吸样模式的可比性进行验证。结果 各检测项目的本底测试、携带污染率、批内精密度和日间精密度均满足仪器要求; 线性验证WBC,RBC,HGB和PLT均满足a值在1±0.05范围内、相关系数r≥0.975的要求; 仪器实测可报告范围均大于厂家申明的可报告范围,临床采用的可报告范围为厂家申明的可报告范围; 正确度验证标本检测均值与定值的偏倚满足正确度要求; 不同吸样模式各检测项目的相对差异亦满足可比性要求。结论 XN-1000血液分析仪的使用性能经验证符合分析质量要求。
Abstract:
Objective To verify the main index of Sysmex XN-1000 hematology analyzer and check whether performance of XN-1000 hematologyanalyzer meet the quality requirement.Methods The background value,carryover rate,precision,linearity,reportable range,accuracy andcomparability of different modes of sample absorbing of Sysmex XN-1000 hematology analyzer were verified and WS/T 406-2012 Analytical Quality Specificationsfor Routine Tests in Clinical Hematology was referred.Results The background counts,carryover rate,inter-batch precision and inter-day precision all met the requirement.Linearity verification of WBC,RBC,HGB and PLT all met the requirement of the value of a within 1±0.05 and the correlation r≥0.975.The reportable range surpassed the range stated by the manufacture,which was accepted as the clinic reportable range.The accuracy test showed the mean and bias all met the requirement.The difference between the valuesdetected by different absorbing modes all met the comparability requirement.Conclusion Performance of Sysmex XN-1000 hematology analyzer was verified to meet the requirement.

参考文献/References:

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备注/Memo

备注/Memo:
作者简介:李琳芸(1980-),女,医学硕士,主管技师,主要从事医学检验专业的临床、研究和教学工作,Tel:0716-8498247,E-mail:linyunli198013@163.com。
通讯作者:肖秀林(1971-),女,医学学士,副主任技师,主要从事血液学检验的临床、研究和教学工作,Tel:0716-8498247,E-mail:xiao9996@163.com。
更新日期/Last Update: 2015-06-10