title: Evaluation of a new hemoglobin A1c analyzer for point-of-care testing.
abstract: BACKGROUND
  There has been an increasing desire for the use of point-of-care testing (POCT) by both primary care clinicians and patients. This study aimed to evaluate the performance of a new POCT analyzer for hemoglobin A1c (HbA1c) testing.
  
  
  METHODS
  We assessed the accuracy, precision, and linearity of the POCT HbA1c analyzer (A1C EZ 2.0) with the Tosoh G8 Analyzer as comparative instrument, following the Clinical and Laboratory Standards Institute (CLSI) protocols. We evaluated sensitivity and specificity of the A1C EZ 2.0 in the clinical diagnosis of diabetes among 842 subjects from 79 communities in Beijing, China.
  
  
  RESULTS
  Using regression analysis, the slope of the A1C EZ 2.0 vs the Tosoh G8 Analyzer was 0.9938, with an intercept of 0.0964 and a concordance correlation coefficient of 0.978. For precision, the reproducibility of CV (CVT) were 3.7% and 2.7% at a lower (36 mmol/mol (5.4%)) and higher (107 mmol/mol (11.9%)) level of HbA1c respectively. The area under the receiver operating characteristic (ROC) curve for clinical diagnosis of diabetes was 0.911 with the HbA1c cut-off value of 44 mmol/mol (6.14%). At the HbA1c level of 48 mmol/mol (6.5%), the sensitivity and specificity were76.1% and 86.6%.
  
  
  CONCLUSIONS
  The A1C EZ 2.0 has a high accuracy and precision, with a wide range of linearity, compared to a comparative laboratory instrument. It met analytical quality specifications and could be suitable for the clinical management of diabetes mellitus.
authors.affiliation: Department of Clinical Laboratory, Beijing Chao-Yang Hospital Affiliated to Capital Medical University, Beijing, China.
authors.forename: Rui
authors.initials: R
authors.lastname: Zhou
authors.affiliation: Department of Blood Transfusion, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.affiliation: Department of Clinical Laboratory, Fang-Shan-Liang-Xiang Hospital, Beijing, China.
authors.forename: Zhi-Xin
authors.initials: ZX
authors.lastname: Song
authors.affiliation: Beijing Center for Clinical Laboratories, Beijing, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Tong
authors.affiliation: Department of Clinical Laboratory, Beijing Chao-Yang Hospital Affiliated to Capital Medical University, Beijing, China.|Beijing Center for Clinical Laboratories, Beijing, China.
authors.forename: Qing-Tao
authors.initials: QT
authors.lastname: Wang
mesh_terms: D000328:Adult; D001774:Blood Chemical Analysis / Q000379:methods; D003920:Diabetes Mellitus / Q000097:blood / Q000175:diagnosis*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D016014:Linear Models; D008297:Male; D000067716:Point-of-Care Testing; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D006442:Glycated Hemoglobin
keywords: community; diabetes; evaluation; hemoglobin A1c; point-of-care testing