Mobile Health for Diagnosis-PixoTest HbA1c POCT System

Abstract

Glycated hemoglobin (HbA1c) has been recommended as a standard indicator of long-term glycemic control for diabetic and non-diabetic patients, within the in vitro diagnostic (IVD) industry that is focused on the development of point-of-care (POC) methods with improved operational convenience and shorter measurement time. In this study, we evaluated the measurement accuracy performance of a recently commercialized POC HbA1c analyzer, PixoTest POCT System (iXensor Co., Ltd.) that is portable, intuitive and wireless data transmission enabled. For PixoTest POCT accuracy evaluation, TOSOH G7 Analyzer (TOSOH Bioscience GmbH) was used as a reference method and performed in accordance with CLSI EP 09-A3 guidelines. This study enrolled one hundred and twenty (120) subjects from three clinical sites (40 subjects each), administered through nine (9) trained operators (total) performed under manufacturer’s protocol using three reagent lots per blood sample (capillary & venous). Linear regression, bias plot and other statistical analyses were extrapolated from the test data. Passing-Bablok regression analysis of the data between PixoTest POCT System and TOSOH G7 Analyzer with the venous blood showed a slope of 1.03 and an intercept of − 0.1 and a correlation coefficient of 0.99. The results for capillary blood showed a slope of 1.01 and an intercept of − 0.04 and a correlation coefficient of 0.99. The PixoTest POCT System’s performance is similar to TOSOH G7 Analyzer in accuracy and linearity. Therefore, the system’s HbA1c test capability is ideal for the management of chronic disease, as a user convenient and efficient POC solution.