Evaluation of Analytical Performance of Point-of-Care Glucose Monitoring Devices in Aminu Kano Teaching Hospital, Kano, Nigeria

Abstract

Introduction: Point of care Glucose Monitoring devices (POCGMDs) provide rapid monitoring of glycaemic control in an acceptable range for diabetic patients in both the hospital and outpatient environments. Poorly calibrated and validated POCGMDs are unreliable and potentially dangerous and usage should be regulated. This study evaluated the analytical performance of POCGMDs at Aminu Kano Teaching Hospital, Nigeria where POCGMDs are commonly used.
Materials and Methods: The accuracy and precision of the POCGMDs glucose readings utilized in the specialty clinics with the reference method employed by the Abbott C4000 at the Central Laboratory of the Hospital were compared using the ISO 15197:2003 and ISO 15197:2013 standards.
Results: Our results showed that Accu-Check active demonstrated an acceptable precision at all levels for repeatability (CV <5%) and reproducibility precision at higher glucose concentrations (i.e. Level 3) whereas Fine Test Auto-coding demonstrated an acceptable precision (CV < 5%) for both repeatability and reproducibility at level 2 and 3 concentrations and failed both at level 1 compared to the reference method. The Mean glucose value for Accu-Chek showed no statistical difference whereas the Fine test auto-coding device showed a statistically significant increase at P < 0.005 compared with the reference method. The linear regression revealed that the two POCGMDs statistically at p < 0.05 overestimated the glucose concentrations compared to the reference method.
Conclusion: This study showed that the two POCGMDs had low precision in comparison to ISO 15197: 2003 and 2013's minimal accuracy requirements, which suggests that their glucose measurement was imprecise. As a result, this study advised employing ISO and ADA criteria for optimal glycaemic control in POCGMDs evaluation and validation to enhance health status.