title: Assessment of a glycated hemoglobin point-of-care analyzer (A1CNow+) in comparison with an immunoturbidimetric method: a diagnostic accuracy study.
abstract: 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.
  
  
  METHODS
  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.
authors.affiliation: Department of Nutrition and Associated Pathologies, Institut de Recherche pour le Développement, Universités Montpellier, Montpellier, France.
authors.forename: Aurélie
authors.initials: A
authors.lastname: Affret
authors.affiliation: Department of Endocrinology, Agamemnon Magalhães Hospital, Universidade de Pernambuco, Recife, Pernambuco, Brazil.
authors.forename: Luiz Henrique Maciel
authors.initials: LH
authors.lastname: Griz
authors.affiliation: Community Health Department, Aggeu Magalhães Research Center, Fundação Oswaldo Cruz, Recife, Pernambuco, Brazil.
authors.forename: Eduarda Ângela Pessoa
authors.initials: EÂ
authors.lastname: Cesse
authors.affiliation: Community Health Department, Aggeu Magalhães Research Center, Fundação Oswaldo Cruz, Recife, Pernambuco, Brazil.
authors.forename: Yuri da Silva
authors.initials: Yda S
authors.lastname: Specht
authors.affiliation: Community Health Department, Aggeu Magalhães Research Center, Fundação Oswaldo Cruz, Recife, Pernambuco, Brazil.
authors.forename: Eduardo Maia Freese de
authors.initials: EM
authors.lastname: Carvalho
authors.affiliation: Department of Nutrition and Associated Pathologies, Institut de Recherche pour le Développement, Universités Montpellier, Montpellier, France.
authors.forename: Annick
authors.initials: A
authors.lastname: Fontbonne
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D003430:Cross-Sectional Studies; D003920:Diabetes Mellitus / Q000097:blood; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006785:Hospitals, University; D006801:Humans; D008297:Male; D008875:Middle Aged; D000067716:Point-of-Care Testing; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D006442:Glycated Hemoglobin