Evaluación de tres sistemas de determinación rápida de hemoglobina A1c para monitorización del control glucémico en pacientes con diabetes mellitus

Abstract

ObjectivesUse of hemoglobin A1c point-of-care devices in physician offices provides immediate results and reduces inconveniences for the patients. We compared the analytical performances of 3 point-of-care HbA1c analyzers to high pressure liquid chromatography (HPLC). Material and methodsWe preselected a pool of 40 EDTA-preserved whole blood samples from our laboratory with HbA1c results obtained by HPLC (mean 6.6% [49 mmol/mol] and range: 4.6-9.9% [27-87 mmol/mol]). Aliquots of theses samples were tested by Afinion AS100, DCA Vantage and In2it point-of-care systems. According the Clinical Laboratory Standards Institute EP-09 protocol we determined linearity (linear regression and correlation coefficient between point-of-care and reference methods), bias (Bland-Altman analysis) and coefficient of variation (%). We used the acceptability criteria endorsed by the National Glycohemoglobin Standardization Program. ResultsThe calculated correlation coefficients (r) were 0.98, 0.98 and 0.83 for Afinion AS100, DCA Vantage and In2it systems, respectively. The 95% confidence interval of the error between point-of-care systems and the reference method was -0.41% and +0.34% (p =.22) for Afinion AS100, -0.62% and +0.05% (p =.57) for DCA Vantage, and -1.15% and +1.26% (p<.001) for the In2it. The coefficients of variation for Afinion AS100, DCA Vantage and In2it systems were 1.80, 3.74 and 7.14%, respectively. ConclusionOnly the Afinion AS100 point-of-care system met all NGSP performance criteria.