title: Accuracy of three hemoglobin A1c point-of-care systems for glucose monitoring in patients with diabetes mellitus.
abstract: OBJECTIVE
  Use of hemoglobin A1c point-of-care devices in physician offices provides immediate results and reduces inconveniences for the patients. We compared the analytical performances of 3 point-of-care HbA1c analyzers to high pressure liquid chromatography (HPLC).
  
  
  METHODS
  We preselected a pool of 40 EDTA-preserved whole blood samples from our laboratory with HbA1c results obtained by HPLC (mean 6.6% [49 mmol/mol] and range: 4.6-9.9% [27-87 mmol/mol]). Aliquots of theses samples were tested by Afinion AS100, DCA Vantage and In2it point-of-care systems. According the Clinical Laboratory Standards Institute EP-09 protocol we determined linearity (linear regression and correlation coefficient between point-of-care and reference methods), bias (Bland-Altman analysis) and coefficient of variation (%). We used the acceptability criteria endorsed by the National Glycohemoglobin Standardization Program.
  
  
  RESULTS
  The calculated correlation coefficients (r) were 0.98, 0.98 and 0.83 for Afinion AS100, DCA Vantage and In2it systems, respectively. The 95% confidence interval of the error between point-of-care systems and the reference method was -0.41% and +0.34% (p =.22) for Afinion AS100, -0.62% and +0.05% (p =.57) for DCA Vantage, and -1.15% and +1.26% (p<.001) for the In2it. The coefficients of variation for Afinion AS100, DCA Vantage and In2it systems were 1.80, 3.74 and 7.14%, respectively.
  
  
  CONCLUSIONS
  Only the Afinion AS100 point-of-care system met all NGSP performance criteria.
authors.affiliation: Servicio de Bioquímica, Hospital Marina Baixa, Villajoyosa, Alicante, España.
authors.forename: María-Eugenia
authors.initials: ME
authors.lastname: Torregrosa
authors.affiliation: Sección de Endocrinología y Metabolismo, Hospital Marina Baixa, Villajoyosa, Alicante, España.
authors.forename: Juan
authors.initials: J
authors.lastname: Molina
authors.affiliation: Sección de Endocrinología y Metabolismo, Hospital Marina Baixa, Villajoyosa, Alicante, España.
authors.forename: Carlos R
authors.initials: CR
authors.lastname: Argente
authors.affiliation: Servicio de Medicina Interna, Hospital Marina Baixa, Villajoyosa, Alicante, España. Electronic address: ena_jav@gva.es.
authors.forename: Javier
authors.initials: J
authors.lastname: Ena
mesh_terms: D002846:Chromatography, Affinity / Q000295:instrumentation / Q000379:methods; D002851:Chromatography, High Pressure Liquid; D000068598:Data Accuracy; D003920:Diabetes Mellitus / Q000097:blood*; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D007841:Latex Fixation Tests / Q000295:instrumentation / Q000379:methods; D016014:Linear Models; D000067716:Point-of-Care Testing; D015203:Reproducibility of Results; D012685:Sepharose / Q000031:analogs & derivatives; D018709:Statistics, Nonparametric
chemical_list: D006442:Glycated Hemoglobin; D012685:Sepharose; C035597:phenylboronic acid-sepharose
keywords: Diabetes mellitus; Diagnóstico rápido; Dispositivos de diagnóstico de HbA1c; Glycated hemoglobin; HbA1c measuring devices; Hemoglobina glucosilada; Point-of-care testing