血栓弹力图性能规范研究

Research on performance specification of thrombelastogram

目的探究如何通过血栓弹力图能力验证活动数据获得基于浓度值变化或恒定的适宜评价标准,帮助临床实验室持续、有效地提高血栓弹力图项目的检测水平。方法收集2018—2021年上海市临床检验中心血栓弹力图能力验证活动各实验室上报数据,统计凝血反应时间、凝血形成时间、角度和血栓最大振幅4个指标的上报数据与靶值之间关联的U-scores函数关系,确定各指标基于浓度值变化或恒定的评价标准。结果凝血反应时间、角度和血栓最大振幅项目U-scores与目标浓度(C)可采用恒定值作为评价标准;凝血形成时间U-scores基于C而变化,宜采用基于浓度值变化的评价标准。结论制定的血栓弹力图检测项目各项指标的性能规范适用于能力验证活动评价标准和室内质量控制允许不精密度要求,能更客观地评价上海地区临床实验室血栓弹力图检测质量。

Objective To investigate how to obtain the appropriate evaluation standard based on the change or constant concentration value as performance standard through thrombelastogram proficiency verification data,and to improve continuously and effectively the determination level of thrombelastogram.Methods The data reported by laboratories participating in the 2018-2020 proficiency verification of Shanghai Center for Clinical Laboratory for thrombelastogram were collected.The relation of U-scores between the reported data of coagulation reaction time,coagulation formation time,angle and maximum amplitude of thrombus and the target value was evaluated,and the evaluation standard of each index based on the change or constant concentration value was obtained.Results The constant concentration values of coagulation reaction time,angle and maximum amplitude of thrombus could be used as evaluation criteria.Coagulation formation time can adopt the evaluation standard based on the change of concentration value.Conclusions The performance specifications of each index of thrombelastogram obtained in this study can be applied to the evaluation standards of proficiency verification and the requirements of allowable imprecision of internal quality control,which can evaluate the determination level of thrombelastogram in Shanghai objectively.