Analytical performance of four HbA1c point-of-care devices: a cross-sectional evaluation in low- and middle-income...

Glycated haemoglobin A1c (HbA1c) measurement is essential for managing diabetes, yet limited data exist on the performance of point-of-care (POC) HbA1c devices in low- and middle-income countries (LMICs). This study evaluated the analytical performance and usability of HbA1c devices in different LMIC settings.

This prospective, cross-sectional multicentre study evaluated the accuracy and usability of four POC devices (i-SENS A1Care, HemoCue HbA1c 501 System, Abbott Afinion 2 and Siemens DCA Vantage) against a laboratory-based HbA1c method at two hospitals in Nigeria and Cambodia.

Adults with or without diabetes and haemoglobin ≥8 g/dL were enrolled.

The primary objective was to evaluate HbA1c POC device accuracy versus laboratory reference testing; secondary objectives evaluated device usability and technical characteristics when used by trained professionals.

Capillary and venous blood samples were tested on all devices using two cartridge lots followed by reference testing. Usability was assessed via operator questionnaires. Accuracy was evaluated using regression slopes, intercept, absolute bias at 30, 48 and 75 mmol/mol, and Bland-Altman analysis, including capillary-venous concordance.

A total of 248 participants completed all study procedures (n=125 in Cambodia, n=123 in Nigeria). Siemens DCA Vantage and Abbott Afinion 2 showed strong agreement with the reference method, with no clinically significant differences and narrow limits of agreement. In contrast, i-SENS A1Care and HemoCue HbA1c 501 System displayed greater bias, especially at elevated HbA1c levels. Most results fell within limits of agreement, though high-HbA1c outliers were more common with the A1Care and HbA1c 501 System devices. Usability feedback was positive overall, when devices were rated across various dimensions, such as clarity of instructions, safety and labelling, although limited user sample size constrains the generalisability of these findings.

Siemens DCA Vantage and Abbott Afinion 2 demonstrated reliable accuracy and usability. In contrast, i-SENS A1Care and HemoCue HbA1c 501 System require cautious interpretation at high HbA1c levels. Ongoing evaluation is critical to ensure the appropriate use of POC devices in diverse clinical settings.

NCT06170515.