Comparative evaluation of HbA1c in point-of-care testing (POCT) devices: enzymatic and immunoassay methods compared to ion-exchange high-performance liquid chromatography (IE-HPLC)

Aim To evaluate 3 point-of-care testing (POCT) devices in testing HbA1c: the Simplex TASTM101 (Tascom Co. Ltd., South Korea), which utilizes an enzymatic method, and two immunoassay-based devices, the Zybio Q8 Pro and Zybio EXR 110 (Zybio Inc., China). Methods A total of 40 whole blood samples with EDTA anticoagulant were collected patients undergoing HbA1c testing at the outpatient department. The samples were analyzed using 3 POCT devices and one reference method. Results Passing-Bablok regression revealed no significant fixed or proportional bias. Strong correlations with the gold standard were observed for Simplex TASTM101 (r=0.944), Zybio Q8 Pro (r=0.910), and Zybio EXR 110 (r=0.839), all with p<0.001. Bland-Altman analysis confirmed that the majority of measurements fell within an acceptable clinical range. Conclusion This study demonstrated that the three POCT devices employing enzymatic and immunoassay methods served as reliable alternatives to ion exchange-high-performance liquid chromatography  (IE-HPLC) for HbA1c measurement in clinical practice.