不同分析原理的凝血仪检测PT和INR值的研究

摘要

目的 分析两种不同原理的凝血仪检测PT和INR值的差异.方法 以Sysmex1500凝血仪为比对方法,Stago compact凝血仪为实验方法,检测50例体检健康者和患者新鲜血浆的PT和INR值,判断两个检测系统间测定结果的可比性.结果 两种不同原理的凝血仪PT值在11～16 s范围内,PT值的相对偏倚(SE%)分别为6.2%和7.3%,INR值在1.5处的相对偏倚为4.3%,＜1/2允许误差;但在医学决定水平20 s处PT值的相对偏倚(SE%)为7.8%,INR值在3.0处的相对偏倚为14.4%,＞1/2允许误差,偏倚不能接受.结论 实验室应定期对凝血仪的分析性能进行评估并建立不同原理凝血仪的参考值范围,最好对来自临床不同科室的样本固定仪器检测,以免两仪器间的结果不同而误导临床诊断治疗.%Objective To analyze the discrepancies of PT and INR values detected by two blood coagulation analyzers based on different theories. Methods To detect 50 cases of the fresh plasma PT and INR values of physical healthy donors and patients with Sysmex 1500 be as control method and Stago be as test method,then compared the results obtained by these two detection systems. Results PT value detected by the two blood coagulation instruments was in the range of 11～16sec. The relative bias (SE%) of PT respectively was 6.2% and 7. 3%, respectively. The relative bias (SE%) of INR values was 4. 3% at five point and less than 1/2 allowed error;but the relative bias (SE%) of PT value was 7. 8% in the medical decision level of 20 sec. Then relative bias of INR value was 14. 4% at 3. 0 point. This value was greater than 1/2 allowed error, so the bias cannot be accepted. Conclusion The laboratory should assess the analytical performance of blood coagulation instruments regularly and establish the reference value range of blood coagulation instrument based on different theories, preferably detect clinical samples from different departments using the constant apparatus to avoid misleading clinical diagnosis and treatment because of the different results obtained by the two instruments.