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血管性血友病的外部同行评审质量保证检测:美国病理学家学会能力验证计划的近期经验

External peer review quality assurance testing in von Willebrand disease: the recent experience of the United States College of American Pathologists proficiency testing program.

作者信息

Hayes Timothy E, Brandt John T, Chandler Wayne L, Eby Charles S, Kottke-Marchant Kandice, Krishnan Jayashree, Lefkowitz Jerry B, Olson John D, Rund Chad R, Van Cott Elizabeth M, Cunningham Mark T

机构信息

Department of Pathology and Laboratory Medicine, Maine Medical Center, Portland, Maine 04102, USA.

出版信息

Semin Thromb Hemost. 2006 Jul;32(5):499-504. doi: 10.1055/s-2006-947864.

Abstract

The U.S. College of American Pathologists (CAP) has conducted a focused study of the proficiency testing for von Willebrand disease (vWD) analysis from 2003 to 2005. This report summarizes the findings regarding the accuracy and precision of the various assays at different analyte levels, as well as the influence of the reference material used to construct the assay standard curve. The results show that testing of von Willebrand factor (vWF):antigen (vWF:Ag) and ristocetin cofactor activity (vWF:RCo) is reasonably accurate, with all-method mean values falling within 3.2 and 5.6%, respectively, of the International Society on Thrombosis and Haemostasis Secondary Coagulation Standard (lot 2) assigned values. vWF:Ag measurements are reasonably precise (all-method coefficients of variation [CVs] = 10.7 to 15.1%), even at lower levels of vWF. The highest precision was observed for immunoturbidometric assays (CVs, 6.3 to 9.7%). vWF:RCo measurements are less precise (all-method CVs, 23.3 to 30.9%). The reference materials used in the standard curves for immunoturbidometric vWF:Ag assays appear to have accurately assigned vWF values for the majority of commercial suppliers.

摘要

美国病理学家学会(CAP)对2003年至2005年血管性血友病(vWD)分析的能力验证进行了专项研究。本报告总结了不同分析物水平下各种检测方法的准确性和精密度,以及用于构建检测标准曲线的参考物质的影响。结果表明,血管性血友病因子(vWF):抗原(vWF:Ag)和瑞斯托霉素辅因子活性(vWF:RCo)检测相当准确,所有方法的平均值分别在国际血栓与止血学会二级凝血标准(批次2)指定值的3.2%和5.6%以内。vWF:Ag测量相当精确(所有方法的变异系数[CVs]=10.7%至15.1%),即使在较低的vWF水平也是如此。免疫比浊法的精密度最高(CVs,6.3%至9.7%)。vWF:RCo测量的精密度较低(所有方法的CVs,23.3%至30.9%)。免疫比浊法vWF:Ag检测标准曲线中使用的参考物质似乎为大多数商业供应商准确分配了vWF值。

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