Sánchez-Mora, CatalinaRodríguez-Oliva, Manuel SFernández-Riejos, PatriciaMateo, JoaquínPolo-Padillo, JuanGoberna, RaimundoSánchez-Margalet, Víctor2015-11-162015-11-162011-04Sánchez-Mora C, S Rodríguez-Oliva M, Fernández-Riejos P, Mateo J, Polo-Padillo J, Goberna R, et al. Evaluation of two HbA1c point-of-care analyzers. Clin. Chem. Lab. Med.. 2011 Apr; 49(4):653-71434-6621http://hdl.handle.net/10668/2056Journal Article;BACKGROUND Measurement of HbA1c is the most important parameter to assess glycemic control in diabetic patients. Different point-of-care devices for HbA1c are available. The aim of this study was to evaluate two point-of-care testing (POCT) analyzers (DCA Vantage from Siemens and Afinion from Axis-Shield). We studied the bias and precision as well as interference from carbamylated hemoglobin. METHODS Bias of the POCT analyzers was obtained by measuring 53 blood samples from diabetic patients with a wide range of HbA1c, 4%-14% (20-130 mmol/mol), and comparing the results with those obtained by the laboratory method: HPLC HA 8160 Menarini. Precision was performed by 20 successive determinations of two samples with low 4.2% (22 mmol/mol) and high 9.5% (80 mmol/mol) HbA1c values. The possible interference from carbamylated hemoglobin was studied using 25 samples from patients with chronic renal failure. RESULTS The means of the differences between measurements performed by each POCT analyzer and the laboratory method (95% confidence interval) were: 0.28% (p<0.005) (0.10-0.44) for DCA and 0.27% (p<0.001) (0.19-0.35) for Afinion. Correlation coefficients were: r=0.973 for DCA, and r=0.991 for Afinion. The mean bias observed by using samples from chronic renal failure patients were 0.2 (range -0.4, 0.4) for DCA and 0.2 (-0.2, 0.5) for Afinion. Imprecision results were: CV=3.1% (high HbA1c) and 2.97% (low HbA1c) for DCA, CV=1.95% (high HbA1c) and 2.66% (low HbA1c) for Afinion. CONCLUSIONS Both POCT analyzers for HbA1c show good correlation with the laboratory method and acceptable precision.endiabetesevaluationHbA1cpoint-of-care testinginterferenceAnálisis químico de la sangreCromatografía líquida de Alta PresiónCromatografía por intercambio IónicoHemoglobina A glucosiladaMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques::Clinical Chemistry Tests::Blood Chemical AnalysisMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Chemistry Techniques, Analytical::Chromatography::Chromatography, Liquid::Chromatography, High Pressure LiquidMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Chemistry Techniques, Analytical::Chromatography::Chromatography, Liquid::Chromatography, Ion ExchangeMedical Subject Headings::Chemicals and Drugs::Carbohydrates::Glycosides::Hemoglobin A, GlycosylatedMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Health Care::Health Care Facilities, Manpower, and Services::Health Facilities::LaboratoriesMedical Subject Headings::Health Care::Health Services Administration::Organization and Administration::Hospital Administration::Hospital Information Systems::Point-of-Care SystemsMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Weights and Measures::Reference ValuesMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Reproducibility of ResultsMedical Subject Headings::Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Epidemiologic Factors::Bias (Epidemiology)research article21323623open access10.1515/CCLM.2011.1011437-4331