Comparación entre 2 sistemas analíticos para la determinación de la hemoglobina A1cinmunoturbidimetría versus cromatografía líquida de alta eficiencia
- Mercedes Lorenzo Medina
- Begoña Uranga Múgica
- Antonio Rus Martínez
- Inmaculada Domínguez Pascual
- Teresa Villalba Hernández
- Mercedes García Gamiz
- Rosa Martínez González
- Rosa Corcoy Plá
- Ernesto Casís Sáenz
ISSN: 1888-4008
Year of publication: 2013
Volume: 6
Issue: 4
Pages: 145-150
Type: Article
More publications in: Revista del laboratorio clínico
Abstract
Introduction Hemoglobin A1c (HbA1c) is widely used to assess glycemic status in patients with diabetes mellitus. The purpose of this study was to compare 2 automated analytical systems to measure HbA1c that use different measurement principles, evaluating the correlation between the two methods, as well as their ease of use. Methods A total of 622 samples were analyzed using 2 methods: high performance liquid chromatography (HPLC) (analyzer ADAMS A1c HA-8160; A. Menarini Diagnostics, Italy) and an immunoturbidimetric assay (Tina-quant Hemoglobin A1c Gen.3, Cobas 6000 analyzer; Roche Diagnostics, Switzerland). Both methods were calibrated in accordance with IFCC reference measurement procedure. The correlation between the two methods was assessed by least squares and Passing-Bablok linear regression analyses (R program v.2.11.1). The daily start-up time of the 2 instruments used, daily maintenance tasks, and determination of throughput were also recorded. Results There was a strong correlation between the results generated by the two test methods using both the least squares (intercept 0.54; slope 0.98) and Passing-Bablok (intercept 0.10; slope 1.00) regression methods. The time spent daily for the start-up of the HA-8160 analyzer was 25 min and completion time was 15 min. Maintenance tasks for the Cobas 6000 analyzer at the beginning and end of the day are automated processes. The throughput for the HA-8160 analyzer was 20 samples/h, and 100 samples/h for the Cobas 6000 analyzer. The HPLC method also included a time-consuming manual analysis of each chromatogram. Conclusions An excellent correlation was observed between the HPLC and immunoturbidimetric methods. The advantages of the immunoturbidimetric method are optimization of processing time of HbA1c tests and a reduction in the unit cost per test.