Evaluation of a HbA1c point-of-care analyzer

A better glycemic monitoring of diabetic patients and avoiding complications of poorly controlled diabetes could be possible with point-of-care testing technology (POCT) for HbA1c determination. B-Analyst® was studied to check whether it complied with the quality requirements for this purpose. We ev...

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Published in:Clinical biochemistry 2015-07, Vol.48 (10-11), p.686-689
Main Authors: Menéndez-Valladares, Paloma, Fernández-Riejos, Patricia, Sánchez-Mora, Catalina, Pérez-Pérez, Antonio, Sánchez-Margalet, Victor, González-Rodríguez, Concepción
Format: Article
Language:English
Subjects:
Chromatography, High Pressure Liquid - standards
Diabetes
Diabetes Mellitus - blood
Evaluation
Glycated Hemoglobin A - analysis
HbA1c
Humans
POCT
Point-of-Care Systems - standards
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Summary:A better glycemic monitoring of diabetic patients and avoiding complications of poorly controlled diabetes could be possible with point-of-care testing technology (POCT) for HbA1c determination. B-Analyst® was studied to check whether it complied with the quality requirements for this purpose. We evaluated the B-Analyst® (Menarini Diagnostics), which is based in the principle of latex agglutination immunoturbidimetry, to assess the validity of the technique of HbA1c. We carried out the method comparison with the HA-8180® (Menarini Diagnostics) as a reference method [High Performance Liquid Chromatography (HPLC)]. We assessed the analytical quality of the B-Analyst® studying the accuracy: inter-assay variability and intra-assay study. Furthermore, possible interferences by hemoglobinopathies were studied. Regression analysis of the data for the method comparison between HA-8180® and B-Analyst® showed a slope of 1.0085 and an intercept of 0.1208. The Pearson's correlation coefficient was 0.9958 (p
ISSN:0009-9120
1873-2933
DOI:10.1016/j.clinbiochem.2015.03.016