• 中国科学论文统计源期刊
  • 中国科技核心期刊
  • 美国化学文摘(CA)来源期刊
  • 日本科学技术振兴机构数据库(JST)
临床输血与检验

临床输血与检验 ›› 2017, Vol. 19 ›› Issue (3): 252-257.DOI: 10.3969/j.issn.1671-2587.2017.03.013

• 临床检验 • 上一篇    下一篇

肝素抗凝治疗监测相关项目的性能验证*

胡欢荣, 李臣宾, 周文宾, 刘秀丽, 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（胡欢荣,刘秀丽,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（李臣宾,周文宾）
  • 收稿日期:2017-02-01 出版日期:2017-06-20 发布日期:2017-06-23
  • 通讯作者: 彭明婷,女,研究员,主要从事临床血液与体液检验标准化及质量控制研究,（E-mail）mtpeng@nccl.org.cn。
  • 作者简介:胡欢荣（1990-）,女,江西上饶人,在读硕士研究生,（E-mail）41232956@qq.com。
  • 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

Verification of Assays for Heparin Therapy Monitoring

HU Huan-rong, LI Chen-bin, ZHOU Wen-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:2017-02-01 Online:2017-06-20 Published:2017-06-23

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摘要： 目的 对低分子量肝素（low molecular weight heparin,LMWH）抗-Ⅹa活性、抗凝血酶（antithrombin,AT）活性和活化部分凝血活酶时间（activated partial thromboplastin time,APTT）检测系统的性能进行验证。方法 参考美国临床和实验室标准协会（CLSI）发布的多项指南、多项卫生行业标准和试剂厂家的要求,对LMWH抗-Ⅹa活性检测的批内精密度、日间精密度、线性、准确度和检出限,AT活性检测的批内精密度、日间精密度、线性和准确度,以及APTT检测的批内精密度、日间精密度和可比性进行验证。结果 LMWH抗-Ⅹa活性检测的批内精密度分别为0.03抗-Ⅹa IU/ml和0.05抗-Ⅹa IU/ml,日间精密度分别为0.04 抗-Ⅹa IU/ml和0.05 抗-Ⅹa IU/ml,线性范围为0~1.83 抗-Ⅹa IU/ml,准确度百分偏差分别为4.3%和2.2%,检出限验证结果为0.05抗-Ⅹa IU/ml,均符合厂家要求。AT活性检测的批内精密度分别为2.0%和3.5%,日间精密度分别为2.7%和5.3%,线性范围为0~139%,准确度百分偏差分别为0.9%、-1.4%和-2.7%,均符合厂家要求。APTT活性检测的批内精密度分别为0.5%和0.4%,日间精密度分别为3.4%和4.4%,可比性验证结果符合行业标准的要求。结论 3个项目的性能能够满足厂家和行业标准的要求,性能验证方法和指标的研究有助于临床实验室实施质量改进。

关键词: 肝素, 实验室监测, 抗-Ⅹa活性, 抗凝血酶, 性能验证

Abstract: Objective To verify the measurement performance of low molecular weight heparin（LMWH） anti-Ⅹa activity assay,antithrombin（AT）activity assay and activated partial thromboplastin time （APTT） test. Methods According to the Clinical and Laboratory Standards Institute （CLSI） guidelines,the professional standards and manufacturer's instructions,the performance characteristics of LMWH anti-Ⅹa activity assay,AT activity assay and APTT test were verified as follows： within-run precision,between-day precision,linearity,accuracy or comparability and the limit of detection （LoD,only for LMWH anti-Ⅹa activity assay）. Results The within-run precision,between-day precision,linear range,bias for accuracy and LoD of LMWH anti-Ⅹa activity assay were 0.03 anti-Ⅹa IU/ml and 0.05 anti-Ⅹa IU/ml,0.04 anti-Ⅹa IU/ml and 0.05 anti-Ⅹa IU/ml,0-1.83 anti-Ⅹ a IU/ml,4.3% and 2.2%,0.05 anti-Ⅹa IU/ml,respectively,all of which were acceptable following manufacturer’s instructions. The within-run precision,between-day precision,linear range and bias for accuracy of AT activity assay were 2.0% and 3.5%,2.7% and 5.3%,0%-139%,0.9%,-1.4% and -2.7%,respectively,all of which were acceptable following manufacturer's instructions. The within-run precision,between-day precision and bias for comparability of APTT test were 0.5% and 0.4%,3.4% and 4.4%,within ±15.0%,respectively,all of which were acceptable according to professional standards and manufacturer's instructions. Conclusion The verified data of the LMWH anti-Ⅹa activity,AT activity and APTT detection systems were acceptable according to the professional standards and manufacturer's instructions. It is very important to set up the Methods and specifications of verification for clinical laboratories to implement quality improvement.

Key words: Heparin, Laboratory monitoring, Anti-Ⅹa activity, Antithrombin, Performance verification

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