FUS-200全自动尿沉渣分析仪的性能评价

曹笠,张广波,许关斌

中国医疗设备 ›› 2017, Vol. 32 ›› Issue (10) : 86-88.

PDF(1466 KB)
PDF(1466 KB)
中国医疗设备 ›› 2017, Vol. 32 ›› Issue (10) : 86-88. DOI: 10.3969/j.issn.1674-1633.2017.10.023
医学工程技术

FUS-200全自动尿沉渣分析仪的性能评价

  • 曹笠,张广波,许关斌
作者信息 +

Performance Evaluation of FUS-200 Automatic Urine Sediment Analyzer

  • CAO Li, ZHANG Guangbo, XU Guanbin
Author information +
文章历史 +

摘要

目的 对FUS-200全自动尿沉渣分析仪质量性能进行评价,证实其性能满足临床要求,并达到ISO 15189标准要求。方 法 按照有关文件规定,对FUS-200全自动尿沉渣分析仪的部分项目进行检测,如精密度、线性范围、携带污染率、稳定性 能、阴性符合率、与人工显微镜检查可比性等各项指标。结果 FUS-200全自动尿沉渣分析仪的各项指标均在文件规定允许 范围内,满足临床需求。结论 必须定期对实验室仪器进行性能验证,确保检测结果的准确性。

Abstract

Objective In this study, the quality performance of the FUS-200 automated urine sediment analyzer was evaluated, and its performance was proved to meet the clinical requirements and the ISO 15189 standard. Methods We evaluated the performance of FUS-200 automated urine sediment analyzer by precision, linearity, carryover contamination rate, stability, the negative coincidence rate and other indicators according to published standard. Results The results of precision, linearity, carryover contamination rate were all in the allowable range. Conclusion Performance verification of laboratory instruments must be performed regularly to ensure the accuracy of the test results.

关键词

全自动尿沉渣分析仪 / 线性范围 / 性能评价 / 精密度 / 稳定性

Key words

automated urine sediment analyzer / linearity range / performance evaluation / precision / stability

引用本文

导出引用
曹笠, 张广波, 许关斌. FUS-200全自动尿沉渣分析仪的性能评价[J]. 中国医疗设备, 2017, 32(10): 86-88 https://doi.org/10.3969/j.issn.1674-1633.2017.10.023
CAO Li, ZHANG Guangbo, XU Guanbin. Performance Evaluation of FUS-200 Automatic Urine Sediment Analyzer[J]. China Medical Devices, 2017, 32(10): 86-88 https://doi.org/10.3969/j.issn.1674-1633.2017.10.023
中图分类号: R446.12   

参考文献

[1] 医学实验室认可培训教材[M].北京:中国合格评定国家认可 委员会,2011.[2] Tholen DW,Kroll M,Astles JR,et al.Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guidline[M].Wayne:CLSI,2003.

PDF(1466 KB)

585

Accesses

0

Citation

Detail

段落导航
相关文章

/