Background: The aim of our study was to evaluate three POC instruments for the measurement of glycated hemoglobin (HbA 1 c) (Cobas b101 (Roche Diagnostics ®), Afinion ™ (Alere Technologies), and B-analyst (Menarini Diagnostics)), which were compared to G8 (Tosoh ®) as the reference method. In addition, the inter-assay and intraassay variability, and linearity of the different techniques were analyzed. Methods: Method comparison was performed according to Clinical and Laboratory Standards Institute (CLSI) EP9-A2 guidelines. We selected 100 samples from the routine laboratory workload and analyzed them in duplicate with the three analyzers, as well as with the reference method. The imprecision study was performed according to CLSI EP5-A2 guidelines for both inter-assay and intra-assay variability. The inter-assay variability was estimated from aliquots of a sample obtained from a blood pool with an HbA 1 c value of 6.1% as determined by the reference method. To establish linearity, the CLSI EP6-A protocol was followed. Results: Method comparison (95% confidence intervals in parentheses): Passing-Bablok regression between the Cobas b101 and the G8, the slope was 0.
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