Dolscheid-Pommerich Ramona C, Dolscheid Sarah, Eichhorn Lars, Stoffel-Wagner Birgit, Graeff Ingo
Department of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Bonn, Germany.
Department of Rehabilitation and Special Education, University of Cologne, Köln, Germany.
PLoS One. 2018 Jan 10;13(1):e0190867. doi: 10.1371/journal.pone.0190867. eCollection 2018.
In acute stroke patients, thrombolysis is one gold standard therapy option within the first four hours after the ischemic event. A contraindication for thrombolysis is an International Normalized Ratio (INR) value >1.7. Since time is brain, rapid and reliable INR results are fundamental. Aim was to compare INR values determined by central laboratory (CL) analyzer and Point-of-Care Testing(POCT)-device and to evaluate the quality of POCT performance in cases of potential therapeutic thrombolysis at a certified stroke unit.
In 153 patients INR measurements using POCT-devices (HEMOCHRON Signature Elite®) were compared to INR measurements (BCS®XP) performed at the central laboratory. Outlier evaluation was performed regarding the critical thrombolysis cut-off.
Overall, we demonstrated a significant correlation (r = 0.809, p<0.0001) between both measurement methods. Mean value of the absolute difference between CL-INR and POCT-INR measurements was 0.23. In 95.4% of these cases, no differences regarding the critical cut-off (INR 1.7) were observed. POCT-INR values tended to be higher than the CL-INR values (p = 0.01). In 4.6% cases, a different value regarding thrombolysis cut-off was found. All patients were >75 years.
POCT-INR measurements based on our POCT concept are suitable to determine INR values in critical stroke patients. Nevertheless, outlier evaluation is mandatory.
在急性中风患者中，溶栓是缺血性事件发生后的头四个小时内的一种黄金标准治疗选择。溶栓的一个禁忌症是国际标准化比值（INR）>1.7。由于时间就是大脑，快速可靠的INR结果至关重要。目的是比较中心实验室（CL）分析仪和即时检验（POCT）设备测定的INR值，并评估在经认证的中风单元中潜在治疗性溶栓病例中POCT性能的质量。
对153例患者使用POCT设备（HEMOCHRON Signature Elite®）测量的INR与中心实验室进行的INR测量（BCS®XP）进行比较。对关键溶栓临界值进行离群值评估。
总体而言，我们证明了两种测量方法之间存在显著相关性（r = 0.809，p<0.0001）。CL-INR和POCT-INR测量之间的绝对差值的平均值为0.23。在95.4%的这些病例中，未观察到关于临界值（INR 1.7）的差异。POCT-INR值往往高于CL-INR值（p = 0.01）。在4.6%的病例中，发现了关于溶栓临界值的不同值。所有患者年龄均>75岁。
基于我们的POCT概念的POCT-INR测量适用于确定重症中风患者的INR值。然而，必须进行离群值评估。
