Department of Pathology and Laboratory Medicine, University of Rochester Medical Center, Rochester, New York, United States.
Department of Medicine, Henry Ford Hospital K-15, Detroit, Michigan, United States.
Thromb Haemost. 2020 Apr;120(4):687-691. doi: 10.1055/s-0040-1708034. Epub 2020 Apr 16.
There are limited publications about the microINR point-of-care (POC) system (iLine Microsystems). The current microINR POC system was compared with the ACL TOP 500 laboratory analyzer (Instrumentation Laboratory) and with the CoaguChek XS POC system (Roche Diagnostics).
This study was performed at three United States medical centers. Sixty-eight nonanticoagulated normal donors and 245 warfarin anticoagulated patients were included. Testing was performed in duplicate using capillary blood samples for the POC systems and venous blood samples for the laboratory testing. Accuracy and imprecision were assessed.
Comparing microINR to ACL revealed a correlation coefficient () of 0.973, a slope of 1.00 (95% confidence interval [CI], 0.97-1.03), and an intercept of 0.08 (95% CI, 0.04-0.15). When compared with the CoaguChek XS, was 0.977 with a slope of 0.92 (95% CI, 0.89-0.94) and an intercept of 0.15 (95% CI, 0.08-0.19). Predicted bias values at international normalized ratio (INR) 2.0, 3.5, and 4.5 were ≤ 5% against both references. Agreement with ACL was 97, 95, and 100% for the INR ranges of < 2.0 ± 0.40, 2.0 to 4.5 ± 20%, and ≥ 4.5 ± 25%, respectively. Agreement for the combined INR ranges was 96% against ACL and > 96% against the CoaguChek XS. The coefficient of variation of the microINR was 5.03% for INR < 2.0 and 4.68% for the therapeutic INR range 2.0 to 3.5.
The microINR results demonstrate adequate imprecision and accuracy to both ACL and CoaguChek XS. This indicates that monitoring INR by this microINR POC system is reliable and acceptable for the management of warfarin therapy.
关于 microINR 即时检测（POC）系统（iLine Microsystems）的出版物有限。本研究将当前的 microINR POC 系统与 ACL TOP 500 实验室分析仪（Instrumentation Laboratory）和 CoaguChek XS POC 系统（罗氏诊断）进行了比较。
该研究在美国三个医疗中心进行。纳入了 68 名非抗凝正常供体和 245 名华法林抗凝患者。使用毛细血管血样对 POC 系统和静脉血样对实验室检测进行重复检测。评估准确性和精密度。
microINR 与 ACL 比较的相关系数（r）为 0.973，斜率为 1.00（95%置信区间[CI]，0.97-1.03），截距为 0.08（95%CI，0.04-0.15）。与 CoaguChek XS 相比，r 为 0.977，斜率为 0.92（95%CI，0.89-0.94），截距为 0.15（95%CI，0.08-0.19）。在 INR 为 2.0、3.5 和 4.5 时，预测偏差值与两个参考值的偏差均≤5%。与 ACL 的一致性分别为 INR 范围为<2.0±0.40、2.0 至 4.5±20%和≥4.5±25%时的 97%、95%和 100%。与 ACL 的联合 INR 范围的一致性为 96%，与 CoaguChek XS 的一致性为>96%。microINR 的变异系数在 INR<2.0 时为 5.03%，在治疗性 INR 范围 2.0 至 3.5 时为 4.68%。
microINR 结果表明，该系统对 ACL 和 CoaguChek XS 的精密度和准确性均足够。这表明通过该 microINR POC 系统监测 INR 对于华法林治疗的管理是可靠和可接受的。
