A-399 Performance Evaluation of Hb A1c Measurements by Using the POC Eclipse PLUS Multi-Purpose Analyzer: Preliminary Results

Abstract Background The Hb A1c test is a core component of diabetes care and provides considerable value in screening and diagnosing diabetes. Due to efforts of the National Glycohemoglobin Standardization Protocol (NGSP) and others, the test, as performed in most laboratories, is now highly standardized. Point of care (POC) Hb A1c testing is convenient, particularly in resource-poor settings and when patients require frequent testing. Devices to measure Hb A1c at POC are commercially available, allowing rapid results when the patient is seen. Moreover, on average, use of POC Hb A1c testing can lead to glycemic control similar to that seen with use of laboratory assays1,2. In this context we aimed to evaluate the performance characteristics of a new available POC Hb A1c analyzer, the Eclipse PLUS Multi-Purpose System and to compare them with a central lab HPLC system. Methods The POC Eclipse PLUS Multi-Purpose analyzer designed and manufactured by Apex Biotechnology Corporation (Hsinchu, Taiwan) using an immunoenzymatic technique for the measurement of Hb A1c in 1µL capillary (fingerstick) or venous whole blood. The Hb NEXT, a reversed-phase cation exchange HPLC analyzer (A. Menarini Diagnostics S.R.L. Florence, Italy), was used for the comparison. Fresh drawn blood of 100 individuals, were measured concurrently in the two instruments. The results were expressed as Mean ± SEM. Results The main results of the study showed that: a) The concentrations of Hb A1c between Eclipse PLUS (6.4 ± 0.10%, ranged 4.7 - 10.9%) and Hb NEXT (6.3±0.10%, ranged 5.0 - 10.8%) did not differ significantly, p>0.526 (95.0% confidence interval for mean of ECLIPSE: 6.4 ± 0.2% [6.2%; 6.6%] and 95.0% confidence interval for mean of NEXT: 6.3 ± 0.2% [6.1%; 6.5%], respectively); b) HbA1c levels measured with the Eclipse PLUS system correlated strongly with the HbA1c levels measured with the Hb Next HPLC system r=0.911, p<0.001 and c) The Bland-Altman analysis of Hb A1c concentrations measured with Eclipse PLUS and HbNext systems revealed a positive bias of 0.09. Conclusion These preliminary data analysis indicate that Eclipse PLUS is convenient and yields glycemic control results similar to those seen with laboratory Hb A1c measurements, in POC setting in a fast and easy way without the employment of trained laboratory personnel. 1. Sacks et al. Diabetes Care 2023;46(10):e151–e199 2. Sacks et al. Diabetes Care 2024;47(7):1104–1110