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首页> 美国卫生研究院文献>Clinical and Applied Thrombosis/Hemostasis >Prospective Comparison of Point-of-Care Device and Standard Analyzer for Monitoring of International Normalized Ratio in Outpatient Oral Anticoagulant Clinic
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Prospective Comparison of Point-of-Care Device and Standard Analyzer for Monitoring of International Normalized Ratio in Outpatient Oral Anticoagulant Clinic

机译：现场护理设备和标准分析仪在门诊口服抗凝剂临床国际标准化率监测方面的前瞻性比较

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Point-of-care testing (POCT) coagulometers are increasingly being used in the hospital setting and patients’ self-testing. We determined the agreement of prothrombin time international normalized ratio (INR) results by POCT coagulometer and laboratory instrument through a comparative analysis and investigated whether the results of POCT coagulometer can reliably be used without being confirmed by standard laboratory analyzer. A total of 200 INR measurements by POCT coagulometer (CoaguChek XS Pro) and laboratory analyzer (Sysmex CS2000i) were compared using Passing-Bablok regression analysis and Bland-Altman plot. Agreement of the INR measurement was further analyzed in relation to dosing decision. The correlation of INR measurements between CoaguChek XS Pro and Sysmex CS2000i was excellent (correlation coefficient = 0.973). The overall mean difference was 0.21 INR ± 0.32 (range: 1.7-0.44). The mean difference was found to get increased as INR results increased and was 0.09 in the subtherapeutic range (≤1.9 INR), 0.29 INR in the therapeutic range (2.0-3.0 INR), while 0.4 INR in the supratherapeutic range (>3.0 INR). The overall agreement was excellent (κ = 0.916) and overall 11 (5.5%) of 200 INR measurements showed a difference in dosing decision between the 2 instruments. The positive bias of POC-INR is evident in the supratherapeutic range which could affect the dosing decision requiring confirmation with the laboratory INR measurement.
机译：即时检验（POCT）血凝仪正越来越多地用于医院环境和患者的自检中。我们通过比较分析确定了POCT血凝仪和实验室仪器的凝血酶原时间国际标准化比率（INR）结果的一致性，并调查了POCT血凝仪的结果是否可以可靠地使用而无需经过标准实验室分析仪的确认。使用Passing-Bablok回归分析和Bland-Altman图，比较了POCT血凝仪（CoaguChek XS Pro）和实验室分析仪（Sysmex CS2000i）进行的总共200 INR测量。 INR测量的一致性与剂量决定有关。 CoaguChek XS Pro和Sysmex CS2000i之间的INR测量相关性极好（相关系数= 0.973）。总体平均差异为0.21 INR±0.32（范围：1.7-0.44）。发现平均差随着INR结果的增加而增加，在亚治疗范围内（≤1.9INR）为0.09，在治疗范围内（2.0-3.0 INR）为0.29 INR，而在超治疗范围内（> 3.0 INR）为0.4 INR。 。总体一致性非常好（κ= 0.916），在200 INR的测量结果中，有11项（5.5％）表明两种仪器之间的剂量决定存在差异。 POC-INR的正偏差在超治疗范围内很明显，这可能会影响需要通过实验室INR测量确认的剂量决定。

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