Kim Sue Jung, Lee Eun Young, Park Rojin, Kim Juwon, Song Jaewoo
Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Korea.
J Clin Lab Anal. 2015 Jan;29(1):28-31. doi: 10.1002/jcla.21722. Epub 2014 Mar 28.
CoaguChek XS is one of the most widely used point-of-care (POC) devices to evaluate prothrombin time for monitoring oral anticoagulant therapy. Unlike laboratory methods, it detects electrical signals produced by thrombin activity to derive the international normalized ratio (INR). Therefore, we hypothesized that laboratory methods and CoaguChek XS could produce different results according to fibrinogen level.
We compared INR values obtained from the CoaguChek XS and conventional laboratory method with 91 plasma samples covering a wide range of fibrinogen levels.
The samples were stratified into low, mid, and high fibrinogen groups by fibrinogen levels of <130 mg/dl, 130-450 mg/dl, and >450 mg/dl, respectively. The mean INR difference of the low fibrinogen group was significantly different from that of the mid or high fibrinogen group (P < 0.001). In the low fibrinogen group, CoaguChek XS INR showed a negative bias compared with the laboratory INR, while the mid and high fibrinogen groups had positive bias.
Our results suggest that patient selection according to fibrinogen status should precede the implementation of POC testing using CoaguChek XS. Also, periodic comparisons between CoaguChek XS and laboratory INR results should be continued during the use of CoaguChek XS.
CoaguChek XS是用于评估凝血酶原时间以监测口服抗凝治疗的最广泛使用的即时检测（POC）设备之一。与实验室方法不同，它通过检测凝血酶活性产生的电信号来得出国际标准化比值（INR）。因此，我们推测实验室方法和CoaguChek XS可能会根据纤维蛋白原水平产生不同的结果。
我们使用91份涵盖广泛纤维蛋白原水平范围的血浆样本，比较了CoaguChek XS和传统实验室方法获得的INR值。
根据纤维蛋白原水平分别<130mg/dl、130 - 450mg/dl和>450mg/dl，将样本分为低、中、高纤维蛋白原组。低纤维蛋白原组的平均INR差异与中或高纤维蛋白原组有显著差异（P<0.001）。在低纤维蛋白原组中，CoaguChek XS INR与实验室INR相比显示出负偏差，而中、高纤维蛋白原组则有正偏差。
我们的结果表明，在使用CoaguChek XS进行即时检测之前，应根据纤维蛋白原状态进行患者选择。此外，在使用CoaguChek XS期间，应继续定期比较CoaguChek XS和实验室INR结果。
