Abstract
Objective To determine the reliability and practicability of the point-of-care- test (POCT) analyzer, Afinion, for capillary HbA1c testing. To assess the benefits of its implementation on the intra-annual follow up of type 2 diabetic patients. Design Descriptive cross-sectional study. Analytical validation of the Afinion reader. Setting Primary Health Care (CAP Carmel and Bon Pastor Clinic Laboratory). Participants A total of 94 type 2 diabetic patients selected according to their previous HbA1c value. Methods We performed one capillary puncture and one venous extraction on each visit. The capillary sample was assessed in real time on the Afinion in the Primary Health Care Centre and the venous sample was sent to Bon Pastor Clinic Laboratory for assessment on an Afinion analyzer and by a high performance liquid chromatrography (HPLC) reference method. Practicability was assesses by both by the operators of the Afinion and the patients using an 11 question questionnaire. The efficiency in terms of process timings was also evaluated. Results Intra-serial coefficient of variation (CV) was lower than 1% and inter-serial lower than 3%. The regression analysis showed: Afinion capillary sample = 0.95 Afinion venous + 0.21. No systematic or proportional error was detected in the 95% confidence interval (95% CI). The comparison between venous HPLC and Afinion showed: Afinion capillary sample = 0.80 HPLC + 1.14. A statistically significant difference was shown for these values at the 95% CI. Practicability was valued by users from 7 to 9.2 (professionals) and from 7.7 to 9.2 (patients). Implementation of the Afinion capillary method for intra-annual testing in follow up of diabetic patients could result in the saving of 600-900 professional hours/year. Conclusions Afinion seems to be a good choice for the intra-annual determination of HbA1c when compared to the traditional process due to its accessibility, practicability and efficiency. Professionals should know the limitations of the POCT method in order to consider the validity of the results.
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