What question did this study set out to answer?

The research aims to compare the effectiveness of three point-of-care testing devices for measuring HbA1c against a gold standard method.

February 28, 2026Medicinski Glasnik0 citationsOpen Access

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)

WAWindradini Rahvian AridamaAirlangga University FMFerdy Royland Marpaung YPYessy PuspitasariAirlangga University

Key Points

The research aims to compare the effectiveness of three point-of-care testing devices for measuring HbA1c against a gold standard method.
Collected 40 whole blood samples with EDTA from patients undergoing HbA1c testing.
Analyzed samples using three POCT devices and one reference method.
Performed Passing-Bablok regression and Bland-Altman analysis to assess correlations and biases.
No significant fixed or proportional bias was found between devices.
Strong correlations were observed with the reference method: Simplex TAS101 (r=0.944), Zybio Q8 Pro (r=0.910), and Zybio EXR 110 (r=0.839), all with p<0.001.
Most measurements collected were within an acceptable clinical range, according to Bland-Altman analysis.

Abstract

pstrongAim/strong To evaluate 3 point-of-care testing (POCT) devices in testing HbA1c: the Simplex TASsupTM/sup101 (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 pstrongMethods/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 pstrongResults/strong Passing-Bablok regression revealed no significant fixed or proportional bias. Strong correlations with the gold standard were observed for Simplex TASsupTM/sup101 (r=0.944), Zybio Q8 Pro (r=0.910), and Zybio EXR 110 (r=0.839), all with plt;0.001. Bland-Altman analysis confirmed that the majority of measurements fell within an acceptable clinical rangestrong./strong/p pstrongConclusion/strong This study demonstrated that the three POCT devices employing enzymatic and immunoassay methods served as reliable alternatives to ion exchange-high-performance liquid chromatographynbsp; (IE-HPLC) for HbA1c measurement in clinical practice./p

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