Abstract:

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.

Key words: Thrombelastogram, Performance specification, Evaluation standard