Performance of the microINR Point-of-Care System: A Multicenter Clinical Trial

Abstract

Introduction 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). Methods 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. Results Comparing microINR to ACL revealed a correlation coefficient (r) 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, r 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. Conclusion 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.

Performance of the microINR Point-of-Care System Used by Self-Testing Patients: A Multicenter Clinical Trial

“…The performance of the microINR system was recently evaluated in a multicenter study in a professional setting. 13 The positive results obtained from the initial study prompted us to further test and evaluate this POC system in a self-testing setting by lay users. All the results of accuracy and precision obtained in this study by HCPs and by self-testing patients with the microINR system are consistent with the results obtained by professionals in the previously reported study.…”

“…All the results of accuracy and precision obtained in this study by HCPs and by self-testing patients with the microINR system are consistent with the results obtained by professionals in the previously reported study. 13 …”

“…In a previous study, we demonstrated adequate precision and accuracy to a laboratory system and to another portable INR device, and thus reliability for the management of warfarin therapy by professional users. 13 Here, we present the outcome of a multicenter study that was conducted to assess the performance of the microINR system by self-testing patients under real-life conditions.…”

The Multiple Faces of Heparin: Opportunities in COVID-19 Infection and Beyond

“…• VKA can be detected by measuring the international normalized ratio in plasma samples. 27 • DOACs can be detected using the DOAC Dipstick in urine samples. 28 Before recovered patients are discharged from hospital, therapy should be switched from heparin/LMWH to VKA or DOACs after the anticoagulant effects of treatment have been specifically tested.…”

Does Chronic Treatment with Oral Anticoagulants Ameliorate the Clinical Course of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection in Coronavirus Disease 2019 (COVID-19)?

“…POC INR tests can determine the intensity of VKA anticoagulation. 8 The available methods for detecting DOACs may be limited by the presence of acute phase proteins and varying platelet counts in COVID-19 patients. 9 The DOAC Dipstick (Doasense GmbH) is a rapid and accurate POC test that can be used on urine samples and is a viable option in emergency situations despite some limitations.…”