Back to Search
Start Over
A step towards optimal efficiency of HbA 1c measurement as a first-line laboratory test: the TOP-HOLE (Towards OPtimal glycoHemOgLobin tEsting) project.
- Source :
-
Clinical chemistry and laboratory medicine [Clin Chem Lab Med] 2022 Jan 18; Vol. 60 (3), pp. 441-450. Date of Electronic Publication: 2022 Jan 18 (Print Publication: 2022). - Publication Year :
- 2022
-
Abstract
- Objectives: The TOP-HOLE (Towards OPtimal glycoHemOgLobin tEsting) project aimed to validate the HbA <subscript>1c</subscript> enzymatic method on the Abbott Alinity c platform and to implement the HbA <subscript>1c</subscript> testing process on the total laboratory automation (TLA) system of our institution.<br />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 <subscript>1c</subscript> 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.<br />Results: For HbA <subscript>1c</subscript> 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 <subscript>1c</subscript> testing, 90% of results were released with a maximum TAT of 1 h, 0.30 FTE resource was also saved.<br />Conclusions: The traceability of Alinity HbA <subscript>1c</subscript> enzymatic assay to the IFCC reference system was correctly implemented. We successfully completed the integration of the HbA <subscript>1c</subscript> testing on our TLA system, without worsening the optimal analytical performance. The shift of HbA <subscript>1c</subscript> testing from s-a mode to TLA significantly decreased TAT.<br /> (© 2022 Walter de Gruyter GmbH, Berlin/Boston.)
- Subjects :
- Humans
Uncertainty
Automation, Laboratory
Hematologic Tests
Subjects
Details
- Language :
- English
- ISSN :
- 1437-4331
- Volume :
- 60
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Clinical chemistry and laboratory medicine
- Publication Type :
- Academic Journal
- Accession number :
- 35041303
- Full Text :
- https://doi.org/10.1515/cclm-2021-1249