Assessment of a glycated hemoglobin point-of-care analyzer (A1CNow+) in comparison with an immunoturbidimetric method: a diagnostic accuracy study.

Autor:	Affret A; Department of Nutrition and Associated Pathologies, Institut de Recherche pour le Développement, Universités Montpellier, Montpellier, France., Griz LH; Department of Endocrinology, Agamemnon Magalhães Hospital, Universidade de Pernambuco, Recife, Pernambuco, Brazil., Cesse EÂ; Community Health Department, Aggeu Magalhães Research Center, Fundação Oswaldo Cruz, Recife, Pernambuco, Brazil., Specht Yda S; Community Health Department, Aggeu Magalhães Research Center, Fundação Oswaldo Cruz, Recife, Pernambuco, Brazil., Carvalho EM; Community Health Department, Aggeu Magalhães Research Center, Fundação Oswaldo Cruz, Recife, Pernambuco, Brazil., Fontbonne A; Department of Nutrition and Associated Pathologies, Institut de Recherche pour le Développement, Universités Montpellier, Montpellier, France.
Jazyk:	angličtina
Zdroj:	Sao Paulo medical journal = Revista paulista de medicina [Sao Paulo Med J] 2015 Nov-Dec; Vol. 133 (6), pp. 460-4. Date of Electronic Publication: 2015 Apr 14.
DOI:	10.1590/1516-3180.2013.9110911
Abstrakt:	Context and Objective: To monitor glycemic control in diabetic patients, regular measurement of glycated hemoglobin (HbA1c) is recommended, but this can be difficult in remote places without access to laboratories. Portable point-of-care testing devices can prove a useful alternative. Our study aimed to assess the performance of one of them: A1CNow+, from Bayer. Design and Setting: Cross-sectional accuracy study conducted at a university hospital in Brazil. Methods: We made three successive measurements of capillary HbA1c using the A1CNow+ in 55 diabetic volunteers, while the same measurement was made on venous blood using the hospital reference method (Vitros 5,1 FS). We used the Bland-Altman graphical method to assess the A1CNow+ in relation to the Vitros 5,1 FS method. We also evaluated clinical usefulness by calculating the sensitivity and specificity of A1CNow+ for detecting patients with HbA1c lower than 7%, which is the usual limit for good glycemic control. Results: The coefficient of variation between repeat testing for the A1CNow+ was 3.6%. The mean difference between A1CNow+ and Vitros 5,1 FS was +0.67% (95% confidence interval, CI: +0.52 to +0.81). The agreement limits of our Bland-Altman graph were -0.45 (95% CI: -0.71 to -0.19) and +1.82 (95% CI: +1.52 to +2.05). The sensitivity and specificity in relation to the 7% limit were respectively 100% and 67.7%. Conclusions: Although the A1CNow+ had good sensitivity, its accuracy was insufficient for use as a replacement for laboratory measurements of HbA1c, for glycemic control monitoring in diabetic patients.
Databáze:	MEDLINE
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