Development and clinical validation of photochemical biosensors for monitoring hemoglobin, blood lipids and uric acid in plateau areas

Abstract

High-altitude regions are prone to plateau erythrocytosis due to unique geo-climatic conditions such as low oxygen, high altitude, and low temperatures, with significantly higher incidences of hyperlipidemia and hyperuricemia compared to lowland areas. However, the extreme environmental conditions at high altitudes and the elevated hematocrit levels in blood samples from these populations present significant challenges to the applicability of existing point-of-care testing (POCT) devices. This study describes the development, early clinical validation, and potential clinical impact of three portable, paper-based photochemical biosensing platforms specifically designed for use at high altitudes to monitor hemoglobin, lipids, and uric acid in blood samples. To systematically evaluate the performance of these sensors, 154 fresh venous blood samples from three distinct altitudes were tested and compared with a reference measurement system, alongside an extensive evaluation for the first time of the suitability of various commercially available POCT devices, including these platforms, for use in high-altitude environments. The results demonstrated that the accuracy and concordance between the developed platforms and the reference system were consistently above 95%. Additionally, concordance remained above 95% when the same samples were tested at varying altitudes (4500 m to 3650 m and 4800 m to 3650 m). All of this indicates that the sensing platform provides high accuracy and reliability for testing in high-altitude environments. It holds promise for broader application in the screening and management of chronic diseases in high-altitude and other extreme environments, and for advancing the use of bedside testing technology in resource-limited settings.