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临床输血与检验

临床输血与检验 ›› 2018, Vol. 20 ›› Issue (4): 402-406.DOI: 10.3969/j.issn.1671-2587.2018.04.021

• 临床检验 • 上一篇    下一篇

自制红细胞沉降率检测参考物质的评价与初步应用*

谷晓争,周文宾,李臣宾,宋真真,彭明婷   

  1. 100730 北京协和医学院研究生院,北京医院,国家老年医学中心,卫生部临床检验中心,北京市临床检验工程技术研究中心（谷晓争,宋真真,彭明婷）；
    北京医院,国家老年医学中心,卫生部临床检验中心,北京市临床检验工程技术研究中心（周文宾,李臣宾）
  • 收稿日期:2018-06-05 出版日期:2018-08-20 发布日期:2018-08-14
  • 作者简介:谷晓争（1988–）,女,河北邯郸人,在读硕士研究生,主要从事临床血液检验项目的标准化研究,（E-mail）xueye@nccl.org.cn；周文宾（1985–）,男,江苏连云港人,助理研究员,主要从事血液体液检验项目的标准化研究,（E-mail）xueye@nccl.org.cn。
  • 基金资助:
    *本课题受国家科技基础性工作专项基金（No.2013FY113800）资助

A Preliminary Assessment of the Self-Made Reference Materials for Detection of Erythrocyte Sedimentation Rate

GU Xiao-zheng,ZHOU Wen-bin,LI Chen-bin,et al.   

  1. Graduate School of Peking Union Medical College,National Center for Clinical Laboratories,Beijing Engineering Technology Research Center of Clinical Laboratory,Beijing Hospital,National Center of Gerontology,Beijing 100730
  • Received:2018-06-05 Online:2018-08-20 Published:2018-08-14

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摘要： 目的 对自制红细胞沉降率检测参考物质进行评价，并试用于室内质量控制。方法 以新鲜动物血为原料，对红细胞进行洗涤和固定，与模拟血浆混合配制成6个批号（ESR01~ESR06）不同沉降率水平的参考物质。参照ISO Guide 35和CNAS-GL03的要求，对自制参考物质和2个批号进口质控物（QC01~QC02）进行均匀性和稳定性评价，并选择3个批号的自制参考物质应用于不同检测系统的室内质量控制，整个过程同时检测进口质控物并进行比较。结果 均匀性评价结果显示，各批号自制参考物质和进口质控物均匀性良好，瓶间差异无统计学意义（P>0.05），沉降率相近的自制物质和进口质控物瓶间均匀性不确定度分别是0.2~1.0 mm/h和0.8~1.5 mm/h。参考物质检测后分别置于室温和冷藏条件，4周内多次重复检测的结果均无趋势性变化（P>0.05），在室温放置时，沉降率随时间变化偏差均在评价标准允许范围内，但在冷藏条件放置时，ESR02、ESR03，ESR04和QC02批号物质沉降率变化的相对偏差分布范围均超出评价标准。自制物质在冷藏条件长期保存，在观察期25周内，自制参考物质和进口质控物检测结果无趋势性变化（P>0.05），沉降率相近的自制和进口质控物长期稳定性不确定度分别是0.1~3.0 mm/h和1.0~2.9 mm/h，沉降率随时间变化的偏差均在评价标准允许范围内。室内质量控制应用结果显示，自制参考物质与沉降率相近的进口质控物检测结果的CV接近。结论 自制血沉参考物质均匀性、稳定性良好，室内质量控制试应用效果良好。

关键词: 红细胞沉降率, 参考物质, 室内质量控制

Abstract: Objective To evaluate the laboratory-made reference materials for detection of erythrocyte sedimentation rate （ESR） in internal quality control （IQC）. Methods Red blood cells separated from fresh animal blood were washed and fixed. Six batches of the reference materials with different ESR values （Lot：ESR01-ESR06） were prepared by mixing with laboratory-made simulated plasma. The homogeneity and stability of the reference materials and the commercial reference materials （Lot：QC01-QC02） were compared following ISO Guide 35 and CNAS-GL03. And three levels of the reference materials with similar ESR value of commercial reference materials were selected for internal quality control in different measuring systems. Results Homogeneity evaluation showed that both reference materials were homogeneous and no difference among bottles was noted （P>0.05）. The bottle-to-bottle homogeneity uncertainty of laboratory-made and commercial reference materials，which were of similar ESR values （e.g. ESR01 Vs QC01，ESR04 Vs QC02），was 0.2 mm/h-1.0 mm/h and 0.8 mm/h-1.5 mm/h，respectively. The results of short-term stability showed no trend change after repeated testing within 4 weeks （P> 0.05） when stored at room temperature or refrigerated condition. However，when stored at refrigerator，the reference reagents （ESR02，ESR03，ESR04 and QC02） gave rise to the fluctuation beyond the evaluation criteria. No trend change （P>0.05） of stability after long-term （25 weeks） storage at refrigerated condition was noted for laboratory-made reference materials. The long-term stability uncertainty of laboratory-made and commercial reference materials （e.g. ESR01 Vs QC01，ESR04 Vs QC02），which were of similar ESR value，was 0.1 mm/h-3.0 mm/h and 1.0 mm/h-2.9 mm/h，respectively. The difference of the ESR value over time was in the range of evaluation criteria. Additionally，the CV of laboratory-made reference materials was found to be close to that of the commercial reference with the similar ESR value in internal quality control. Conclusion The laboratory-made reference materials are of high homogeneity and stability and can be used in internal quality control of clinical laboratory diagnosis.

Key words: Erythrocyte sedimentation rate, Reference reagents, Internal quality control

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