title: Evaluation of a HbA1c point-of-care analyzer.
abstract: OBJECTIVE
  A better glycemic monitoring of diabetic patients and avoiding complications of poorly controlled diabetes could be possible with point-of-care testing technology (POCT) for HbA1c determination. B-Analyst® was studied to check whether it complied with the quality requirements for this purpose.
  
  
  METHODS
  We evaluated the B-Analyst® (Menarini Diagnostics), which is based in the principle of latex agglutination immunoturbidimetry, to assess the validity of the technique of HbA1c. We carried out the method comparison with the HA-8180® (Menarini Diagnostics) as a reference method [High Performance Liquid Chromatography (HPLC)]. We assessed the analytical quality of the B-Analyst® studying the accuracy: inter-assay variability and intra-assay study. Furthermore, possible interferences by hemoglobinopathies were studied.
  
  
  RESULTS
  Regression analysis of the data for the method comparison between HA-8180® and B-Analyst® showed a slope of 1.0085 and an intercept of 0.1208. The Pearson's correlation coefficient was 0.9958 (p<0.0001). Bias study showed a mean difference from B-Analyst® with respect to HA-8180® of 0.1872 with a 95% confidence interval. The standard error of the estimate (Syx) was 0.2091. The concordance correlation coefficient to assess accuracy was 0.9922 (0.9891-0.9945). The CV for the inter-assay study was 1.4%. For the intra-assay study we analyzed 3 samples with different HbA1c % whose CV were 1.03% [4.7% HbA1c (28 mmol/mol)], 0.46% [6.4% HbA1c (46 mmol/mol)] and 0.78% [8.1% HbA1c (65 mmol/mol)].
  
  
  CONCLUSIONS
  The B-Analyst® evaluated not only showed good correlation with HA-8180®, but also it presented a great accuracy both in the inter-assay and in the intra-assay studies. The B-Analyst® complies with quality specifications required for monitoring of diabetic patients.
authors.affiliation: Clinical Biochemistry Department, Virgen Macarena University Hospital, Seville, Spain. Electronic address: palomamenval@hotmail.com.
authors.forename: Paloma
authors.initials: P
authors.lastname: Menéndez-Valladares
authors.affiliation: Clinical Biochemistry Department, Virgen Macarena University Hospital, Seville, Spain.
authors.forename: Patricia
authors.initials: P
authors.lastname: Fernández-Riejos
authors.affiliation: Clinical Biochemistry Department, Virgen Macarena University Hospital, Seville, Spain.
authors.forename: Catalina
authors.initials: C
authors.lastname: Sánchez-Mora
authors.affiliation: Clinical Biochemistry Department, Virgen Macarena University Hospital, Seville, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Pérez-Pérez
authors.affiliation: Clinical Biochemistry Department, Virgen Macarena University Hospital, Seville, Spain.
authors.forename: Victor
authors.initials: V
authors.lastname: Sánchez-Margalet
authors.affiliation: Clinical Biochemistry Department, Virgen Macarena University Hospital, Seville, Spain.
authors.forename: Concepción
authors.initials: C
authors.lastname: González-Rodríguez
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000592:standards; D003920:Diabetes Mellitus / Q000097:blood; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D019095:Point-of-Care Systems / Q000592:standards*
chemical_list: D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human
keywords: Diabetes; Evaluation; HbA1c; POCT