As of 2021, the International Diabetes Federation (IDF) reports that approximately 537 million people globally are living with diabetes, and this disease is responsible for 6.7 million deaths each year. By 2045, the global prevalence of diabetes is predicted to increase by 46% with the highest increase in low and middle-income countries. The incidence of diabetes among people under 20 years of age is increasing in most global populations, with the US experiencing a 5% yearly increase during the period between 2002 and 2015. The World Health Organization (WHO) has established a target to stop the rise of diabetes by 2025. Here, we describe the development and testing of HemeChip-GHb, the first miniaturized, paper-based microchip affinity electrophoresis platform for quantitative detection of glycosylated hemoglobin (HbA1) at the point-of-care.
The HemeChip-GHb is developed based on the HemeChip technology, which has been previously developed to test for hemoglobinopathies such as sickle disease, beta thalassemia and anemia, and is commercialized under the product name “GazelleTM”. Feasibility and accuracy of the HemeChip-GHb system were demonstrated by testing blood samples collected from healthy donors, patients with prediabetes, and patients with diabetes. The results show that HbA1 levels measured with HemeChip-GHb have 0.96 correlation to the levels reported from the clinical standard HPLC tests, and with a bias of -0.72% based on Bland-Altman analysis. 99.6 % of the HbA1 levels for paired HemeChip-GHb and HPLC fell within A and B zones of no difference in clinical outcome based on error grid analysis.
HemeChip-GHb is a robust microchip electrophoresis technology that has the potential to address the urgent need for an affordable, accurate and portable POC platform for diabetes diagnosis and monitoring in resource-challenged environments, especially in patients with co-existing hemoglobinopathies and anemia.