%0 Journal Article
%9 ACL : Articles dans des revues avec comité de lecture répertoriées par l'AERES
%A Affret, A.
%A Griz, L. H. M.
%A Cesse, E. A. P.
%A Specht, Y. D.
%A de Carvalho, E. M. F.
%A Fontbonne, Annick
%T Assessment of a glycated hemoglobin point-of-care analyzer (A1CNow+) in comparison with an immunoturbidimetric method : a diagnostic accuracy study
%D 2015
%L fdi:010066118
%G ENG
%J Sao Paulo Medical Journal
%@ 1516-3180
%K Hemoglobin A, glycosylated ; Point-of-care systems ; Technology assessment, biomedical ; Diabetes mellitus ; Primary health care
%K BRESIL
%M ISI:000368271900002
%N 6
%P 460-464
%R 10.1590/1516-3180.2013.9110911
%U https://www.documentation.ird.fr/hor/fdi:010066118
%> https://www.documentation.ird.fr/intranet/publi/2016/02/010066118.pdf
%V 133
%W Horizon (IRD)
%X 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.
%$ 054