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)

<p><strong>Aim</strong> To evaluate 3 point-of-care testing (POCT) devices in testing HbA1c: the Simplex TAS<sup>TM</sup>101 (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).</p> <p><strong>Methods</strong> 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.</p> <p><strong>Results</strong> Passing-Bablok regression revealed no significant fixed or proportional bias. Strong correlations with the gold standard were observed for Simplex TAS<sup>TM</sup>101 (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<strong>.</strong></p> <p><strong>Conclusion</strong> 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.</p>