在接受Phenprocoumon抗凝治疗的患者中评价LumiraDx INR测试的准确性

Point of Care: The Journal of Near-Patient Testing & Technology Pub Date : 2020-09-01 DOI:10.1097/POC.0000000000000207

H. Völler, K. Heyne

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引用次数: 0

摘要

LumiraDx INR测试是一种新的即时诊断测试，用于分析手指刺血样本。该试验在接受phenprocoumon (NCT04074980)治疗的患者中进行评估。方法采用LumiraDx INR检测法测定静脉血浆国际标准化比值(INR)。将LumiraDx INR测试确定的毛细血管全血INR与使用IL ACL Elite Pro和Sysmex CS-5100参考仪器测量的静脉血浆INR进行比较。结果共纳入102例使用phenprocoumon的患者。LumiraDx INR测试分析的静脉血浆和毛细血管全血INR结果与IL ACL Elite Pro测量的INR结果具有良好的相关性(血浆:n = 25, r = 0.981;毛细管血:n = 74, r = 0.949)和Sysmex CS-5100 (n = 73, r = 0.950)。结论LumiraDx INR检测法对phenprocoumon患者的静脉血浆和毛细血管全血分析具有较高的准确性。

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Evaluation of the Accuracy of the LumiraDx INR Test Using Patients in Receipt of Phenprocoumon Anticoagulation Therapy

Background The LumiraDx INR Test is a new point-of-care diagnostic test designed to analyze fingerstick blood samples. The test was assessed in patients receiving phenprocoumon (NCT04074980). Methods Venous plasma international normalized ratio (INR) was measured using the LumiraDx INR Test. LumiraDx INR Test-ascertained capillary whole blood INR was compared with venous plasma INR measured using the IL ACL Elite Pro and Sysmex CS-5100 reference instruments. Results A total of 102 patients receiving phenprocoumon were recruited. The INR results from venous plasma and capillary whole blood that were analyzed on the LumiraDx INR Test correlated well with those measured using the IL ACL Elite Pro (plasma: n = 25, r = 0.981; capillary blood: n = 74, r = 0.949) and the Sysmex CS-5100 (n = 73, r = 0.950). Conclusions The LumiraDx INR Test showed high accuracy in analyzing venous plasma and capillary whole blood from patients receiving phenprocoumon.

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Point of Care: The Journal of Near-Patient Testing & Technology

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