A step towards optimal efficiency of HbA 1c measurement as a first-line laboratory test: the TOP-HOLE (Towards OPtimal glycoHemOgLobin tEsting) project.

Objectives: The TOP-HOLE (Towards OPtimal glycoHemOgLobin tEsting) project aimed to validate the HbA _1c enzymatic method on the Abbott Alinity c platform and to implement the HbA _1c testing process on the total laboratory automation (TLA) system of our institution.
Methods: Three different measuring systems were employed: Architect c4000 stand-alone (s-a), Alinity c s-a, and Alinity c TLA. Eight frozen whole blood samples, IFCC value-assigned, were used for checking trueness. A comparison study testing transferability of HbA _1c results from Architect to Alinity was also performed. The alignment of Alinity TLA vs. s-a was verified and the measurement uncertainty (MU) estimated according to ISO 20914:2019. Turnaround time (TAT) and full time equivalent (FTE) were used as efficiency indicators.
Results: For HbA _1c concentrations covering cut-offs adopted in clinical setting, the bias for both Architect and Alinity s-a was negligible. When compared with Architect, Alinity showed a mean positive bias of 0.54 mmol/mol, corresponding to a mean difference of 0.87%. A perfect alignment of Alinity TLA to the Alinity s-a was shown, and a MU of 1.58% was obtained, widely fulfilling the desirable 3.0% goal. After the full automation of HbA _1c testing, 90% of results were released with a maximum TAT of 1 h, 0.30 FTE resource was also saved.
Conclusions: The traceability of Alinity HbA _1c enzymatic assay to the IFCC reference system was correctly implemented. We successfully completed the integration of the HbA _1c testing on our TLA system, without worsening the optimal analytical performance. The shift of HbA _1c testing from s-a mode to TLA significantly decreased TAT.
(© 2022 Walter de Gruyter GmbH, Berlin/Boston.)