Hematocrit Self-Testing in Patients with Polycythemia Vera: A Proof-of-Concept Study Assessing the Accuracy of the Statstrip Xpress ® 2 Hb/Hct Device and Its Impact on Patients' Quality of Life in Clinical Practice

Introduction: Patients with polycythemia vera (PV) have an increased risk of morbidity and mortality from thromboembolic events and cardiovascular disease, particularly for hematocrit (Hct) levels > 45% (Marchioli et al., 2013). Maintaining Hct < 45% is therefore important to reduce these risks. A device that patients can use to frequently monitor their own Hct levels could provide a detailed picture of the change in Hct over time, enable timely clinical visits and disease management, reduce disease burden, and increase patients' quality of life (QoL). A meter to measure hemoglobin (Hb) and Hct that has been approved for medical professional use (StatStrip Xpress ® 2 Hb/Hct meter, Nova Biomedical Corporation) has potential as an at-home, self-testing device.