期刊文献+

迈瑞BC-5800全自动血液分析仪性能评价 被引量:2

下载PDF
导出
摘要 目的对迈瑞BC-5800全自动血液分析仪进行性能评价。方法按照国际血液学标准化委员会(ICSH)和美国临床实验室标准化委员会(NCCLS)制定的评价方案为标准进行评价试验。结果 BC-5800检测全血细胞计数(CBC)线性良好,相关系数(r)均为0.999,携带污染率非常低,CBC各参数的精密度高,其与Beckman Coulter公司HMX血液分析仪测定结果比较,相关性极好,差异无统计学意义。与手工法分类白细胞结果比较,中性粒细胞、淋巴细胞、嗜酸性粒细胞的相关系数(γ)达到0.93以上,而单核细胞和嗜碱性粒细胞也达0.826和0.676。结论迈瑞BC-5800血液细胞分析仪各方面性能良好,测定准确可靠,对大批量的全血标本能够进行快速而有效的筛检。
出处 《国际检验医学杂志》 CAS 2011年第18期2120-2121,共2页 International Journal of Laboratory Medicine
  • 相关文献

参考文献7

二级参考文献16

  • 1常玉荣,石峻,殷华,何晓娟.血细胞形态学观察对血液系统疾病诊断的意义[J].检验医学,2007,22(1):78-80. 被引量:14
  • 2U.S. Department of Health and Human Services. 42 CFR Part 493: medicare, medicaid and CLIA programs;Laboratory requirements relating to quality systems and certain personnel qualifications; Final rule[ J ]. Federal Register, 2003,68:3640-3714.
  • 3Jan SK. Evaluation of assay systems [ J ]. Clin Lab News,2001,27 : 10-14.
  • 4Laessig RH, Ehrmeyer SS, Leinweber JE. Intralaboratory performance requirements necessary to pass proficiency testing: CAP-1990 vs CLIA-1967 ( March 14,1990) formats compared [ J ]. Clin Chem, 1992,38 :895-903.
  • 5U.S. Department of Health and Human Services.Medical devices;Current good manufacturing practice(CGMP) final rule :quality system regulation. 21 CFRParts 808,812 and 820 [ J ]. Federal Register, 1996,61 : 52602-52662.
  • 6National Committee for Clinical Laboratory Standards.Evaluation of precision performance of clinical chemistry devices, approved guideline [ S ]. Wayne, PA:EPSoA. NCCLS. 1999.
  • 7U.S. Department of Health and Human Services.Medicare,medicaid and CLIA programs; Regulationsimplementing the clinical laboratory improvement amendments of 1998 (CLIA). Final rule [ J ]. Fed Regist, 1992,57:7002-7186.
  • 8VITROS system verification [ S ]. Ortho-Clinical Diagnotics, USA ,2004.
  • 9National Committee for Clinical Laboratory Standards.User demonstration of performance for precision and accuracy [ S ]. Wayne, PA : EP15-P. NCCLS. 1998.
  • 10National Committee for Clinical Laboratory Standards.Method comparison and bias estimation using patientsamples, approved guideline [ S ].2nd ed. Wayne, PA :EP9-A2. NCCLS. 2002.

共引文献138

同被引文献9

引证文献2

二级引证文献2

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部