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

Robert R Orr,Majed A Refaai,Alan K Jacobson,Jack C Rosenfeld

doi:10.1055/s-0041-1740962

Abstract

Introduction Anticoagulation monitoring is a major practical and clinical challenge. We assessed the performance of the microINR system in patient self-testing (PST). Methods This study was performed at four US medical centers. After the training visit of warfarin anticoagulated patients ( n = 117) on microINR system, PST was performed at home and in two visits to the medical centers. At the medical centers, both PST and healthcare professionals (HCPs) performed duplicate tests with the microINR System. A venous blood sample for the laboratory testing was also extracted. Accuracy and precision were assessed. Results The comparison between microINR PST results and microINR HCP results revealed an equivalence with a slope of 1.00 (95% confidence interval [CI]: 1.00–1.00), and an intercept of 0.00 (95% CI: 0.00–0.00). When compared with the laboratory analyzer, microINR PST results also showed good correlation with a slope of 0.94 (95% CI: 0.86–1.04) and an intercept of 0.14 (95% CI: -0.09–0.34). Predicted bias values at international normalized ratio (INR) 2.0, 3.5, and 4.5 were 0% against HCP and ≤2.5% against the laboratory. Analytical agreement with both HCP and laboratory was 100% according to ISO17593 and 99.1 and 100% according to CLSI POCT14 with HCP and laboratory, respectively. Clinical agreement with HCP regarding 2.0–4.0 as INR therapeutic range was 98% (within range). The precision (coefficient of variation) of microINR system used by PST was comparable to HCP. Conclusion The microINR results when used by self-testing patients show satisfactory concordance to both HCP results and laboratory analyzer. The microINR system is adequate for self-testing use.

Highlights

Anticoagulation monitoring is a major practical and clinical challenge
The comparison between microINR patient self-testing (PST) results and microINR healthcare professional (HCP) results revealed an equivalence with a slope of 1.00 (95% confidence interval [CI]: 1.00–1.00), and an intercept of 0.00
Predicted bias values at international normalized ratio (INR) 2.0, 3.5, and 4.5 were 0% against HCP and 2.5% against the laboratory. Analytical agreement with both HCP and laboratory was 100% according to ISO17593 and 99.1 and 100% according to CLSI POCT14 with HCP and laboratory, respectively

Summary

Introduction

We assessed the performance of the microINR system in patient self-testing (PST). After the training visit of warfarin anticoagulated patients (n 1⁄4 117) on microINR system, PST was performed at home and in two visits to the medical centers. Both PST and healthcare professionals (HCPs) performed duplicate tests with the microINR System. The anticoagulation effect of VKA therapy is monitored by the international normalized ratio (INR) method of reporting the prothrombin time. The patient self-testing (PST) model, where patients perform INR testing by themselves and report results to a HCP, provided significant advantages to warfarin anticoagulation monitoring. The patient self-management (PSM) model upon which patients perform by themselves both INR testing and the dose adjustment augmented INR POC benefits. In comparison to the other regular monitoring models, PST and PSM models showed significant decrease in thromboembolic and bleeding events and provided better clinical outcomes.[1,2,3,4,5] This is mainly due to the improvement in the time in therapeutic range (TTR)

Methods

Results

Conclusion