Niederdöckl J, Dempfle C-E, Schönherr H-R, Bartsch A, Miles G, Laggner A, Pathil A
Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.
Coagulation Center Mannheim, Mannheim, Germany.
Int J Lab Hematol. 2016 Aug;38(4):426-34. doi: 10.1111/ijlh.12519. Epub 2016 Jul 7.
There are several clinical settings and patient conditions especially in intensive care units, emergency departments, and operating theaters, where the coagulation status of a patient must be known immediately and point-of-care (POC) systems are beneficial due to low time to result.
This noninterventional, single-blinded, multicenter study with prospectively collected whole blood samples was performed to evaluate the diagnostic accuracy of the CoaguChek PT Test (POC PT) and CoaguChek aPTT Test (POC aPTT) compared to standard laboratory testing in patients with suspected deficiencies of coagulation factors.
In total, 390 subjects were included. Both POC PT and POC aPTT showed concordance with the laboratory PT and aPTT. Lot-to-lot variation was below 2% both for POC PT and for POC aPTT. The mean relative difference of capillary blood compared to venous blood was 0.2 % with POC PT and 8.4% with POC aPTT. The coefficients of variation for repeatability of POC PT using whole blood were found to be between 2% and 3.6%.
Our findings suggest reliable quantitative results with this POC system to support on-site decision-making for patients with suspected deficiencies of coagulation factors in acute and intensive care.
在多种临床环境和患者状况下，尤其是在重症监护病房、急诊科和手术室，必须立即了解患者的凝血状态，而即时检验（POC）系统因其出结果时间短而具有优势。
本项非干预性、单盲、多中心研究，前瞻性收集全血样本，旨在评估与标准实验室检测相比，CoaguChek PT检测（POC PT）和CoaguChek aPTT检测（POC aPTT）在疑似凝血因子缺乏患者中的诊断准确性。
共纳入390名受试者。POC PT和POC aPTT均与实验室PT和aPTT结果一致。POC PT和POC aPTT的批次间差异均低于2%。与静脉血相比，POC PT检测毛细血管血的平均相对差异为0.2%，POC aPTT检测为8.4%。使用全血时，POC PT重复性的变异系数在2%至3.6%之间。
我们的研究结果表明，该POC系统可提供可靠的定量结果，有助于在急性和重症监护环境中为疑似凝血因子缺乏的患者进行现场决策。
