临床凝血检验的测量不确定度评估

目的：初步探索测量不确定度在临床凝血检验中的应用。方法分析不确定度分量的来源并采用 A、B 类评定方法，评定本实验室几个常规凝血项目（PT、APTT、FIB）的测量不确定度，合成标准不确定度（uC），计算扩展不确定度（U）。结果常规凝血项目的不确定度不尽相同，PT、APTT、FIB的A类不确定度分别为0．0250、0．0731、0．0280；B类不确定度分量uB1分别为0．0658，0．1478，0．1221；uB2均为0．0070；uB3均为0．0001；uB4均为0．0078；uB5均为0．0177。计算 uC（PT）、uC （APTT）、uC（FIB）分别为0．0733、0．1662、0．1269，U（PT）、U（APTT）、U（FIB）分别为0．1466、0．3324、0．2538。结论本研究采用A、B 类评定方法，对凝血检验中测量不确定度进行评估，作为临床凝血检验工作的不确定度研究的初步探索，以期为临床诊断、治疗、预后提供更为客观、可靠的依据。

Measurement uncertainty of clinical coagulation tests

Objective This study was aimed to investigate the application of measurement uncertainty in clinical coagulation tests. Methods The source of measurement uncertainty was analyzed, and the conventional coagulation indexes （PT, APTT, FIB） were estimated according to A and 13 type method. The relative standard uncertainties （uC） were combined, and expanded uncertain- ty （U） was calculated. Results The measurement uncertainty varied among these indexes,A type uncertainties from PT, APTT, FIB were 0. 025 0,0. 073 1,0. 028 0,respectively; B type uncertainties uB1 were 0. 065 8,0. 147 8,0. 122 1 for PT,APTT,FIB,re- spectively; and uB2 were all 0. 007 0;uB3 were all 0. 000 1;uB4 were all 0. 007 8;uB5 were all 0. 017 7. uC（PT） ,uC（APTT） ,uC （FIB） was calculated as 0. 073 3,0. 166 2,0. 126 9,respectively,and U（PT） ,U（APTT） ,U（FIB） were 0. 1466,0. 3324,0. 2538 re- spectively. Conclusion A and B type method was used in this study to evaluate measurement uncertainty in coagulation tests,it may provide preliminary exploration of measurement uncertainty in coagulation test, and provide more objective and reliable basis for clinical diagnosis, treatment and prognosis.