A-375 Evaluation of the CLIA-Waived Afinion HbA1c Point-of-Care Test

Abstract

Abstract Background Point-of-care (POC) HbA1c tests can be essential in evaluation/monitoring of diabetes provided that the test has acceptable analytical performance. The Abbott Afinion HbA1c is an in vitro diagnostic test for quantification of HbA1c in human capillary and venous whole blood. This study aim was to evaluate the performance of Afinion HbA1c in whole blood EDTA patient samples. Methods The Afinion utilizes the boronate affinity principle for measurement of HbA1c. Hemoglobin A1c was tested on the Abbott AfinionTM 2 analyzer. Two levels of quality control (QC) and two levels of whole blood EDTA patient samples (one low and on high) were used to assess imprecision. Within-day precision was determined by assaying the 20 times in one day and between-day precision was determined by assaying the samples in duplicates over a period of 10 days. The analytical measured range (AMR) and method comparison was performed by using whole blood EDTA patient samples. Percent bias plot and Deming regression analysis was performed by EP Evaluator. Results Within-day and between-day precision and accuracy data are summarized in table 1 below. The assay displayed good linearity over the measured AMR. Lastly, the method comparison between Afinion vs Cobas pro, had a correlation coefficient R2 of 0.994, slope (m) of 1.14 and % bias was 2.5%. Afinion vs Trinity Biotech HPLC had R2 = 0.996, m = 1.04 and % bias was −2.3%. Afinion vs DCA Vantage had R2 = 0.991, m = 1.03 and % bias 1.5. Conclusion We conclude that the Abbott Afinion POC device evaluated here is precise and yields results consistent with other Clinical Chemistry analyzers such as Cobas Pro and Trinity Biotech.