临床凝血检验项目测量不确定度的评定

Evaluation of measurement uncertainty for coagulation tests in clinical laboratory

目的评定凝血检验部分项目测量不确定度。方法利用SYSMEXCA7000及SIEMENS配套试剂分析PT、APTT、Fbg、TT,计算偏倚,分析检测中测量不确定度分量,计算扩展测量不确定度。结果报告了各检测项目的测量不确定度,PT、APTT、Fbg、TT的扩展不确定度分别为1.54s、1.72s、0.24g/L、0.84s。结论凝血检验项目不确定度表示测量值的分散区间,而不是单一的数据点,在评估不确定度时,引入生物学变异,对临床有更大的参考价值。

Objective To evaluate the measurement uncertainty of coagulation tests, such as PT, APTT, Fbg and TT. Methods SYSMEX CA7000 and the matched SIEMENS reagents were employed to analyze PT, APTT, Fbg, TT. The bias was calculated, and the measurement uncertainty was determined. Results The expanded measurement uncertainty for PT, APTT, Fbg, TT was 1.54 s, 1.72 s, 0.24 g/L, 0.84 s, respectively. Conclusion Measurement uncertainty shows the dispersion of the values. Under this notion, all the values should be a range other than at a single point. The introduction of biological variation has great significance in the evaluation of measurement uncertainty in clinical practice.