title: Improvement in the Quality of HbA1c Determination by Using Commutable Specimens With IFCC-Assigned Values.
abstract: BACKGROUND
  To assess the usefulness of commutable secondary reference materials with International Federation of Clinical Chemistry (IFCC)-assigned values, for improving the quality of hemoglobin A1c (HbA 1c ) determination.
  
  
  METHODS
  We recalibrated and evaluated 3 point-of-care-test (POCT) devices via 3 different method-specific central laboratory analyzers that were calibrated using commutable specimens with IFCC-assigned values. The staff members who performed POCT were also evaluated before and after training.
  
  
  RESULTS
  HbA 1c levels measured with POCT devices showed significantly lesser bias after external mathematical calibration. The interlaboratory CVs for HbA 1c measurements decreased from 12% to 4% after training of POCT-device-operating personnel in the NycoCard group. The CVs in the DCA Vantage and Afinion groups also improved after training.
  
  
  CONCLUSIONS
  Calibration of laboratory devices by specimens with IFCC-assigned values and by external mathematical calibration could improve the accuracy of POCT HbA 1c measurements. Also, standardized training could improve precision in POCT HbA 1c measurements, especially for semiautomated HbA 1c POCT devices.
authors.affiliation: Clinical Laboratory Department, Beijing Chao-Yang Hospital, affiliated to Capital Medical University, Beijing, China.
authors.forename: Rui
authors.initials: R
authors.lastname: Zhou
authors.affiliation: Clinical Laboratory Department, Beijing Chao-Yang Hospital, affiliated to Capital Medical University, Beijing, China.
authors.forename: Zhi-Qi
authors.initials: ZQ
authors.lastname: Gao
authors.affiliation: Beijing Center for Clinical Laboratories, Beijing, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Tong
authors.affiliation: Clinical Laboratory Department, Beijing Chao-Yang Hospital, affiliated to Capital Medical University, Beijing, China.
authors.forename: Chang
authors.initials: C
authors.lastname: Zuo
authors.affiliation: Clinical Laboratory Department, Fang-Shan-Liang-Xiang Hospital, Beijing, China.
authors.forename: Zhi-Xin
authors.initials: ZX
authors.lastname: Song
authors.affiliation: Blood Transfusion Department of Beijing Di-tan Hospital Affiliated to Capital Medical University, Beijing, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.affiliation: Clinical Laboratory Department, 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: D001774:Blood Chemical Analysis / Q000592:standards*; D002138:Calibration; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D016014:Linear Models; D019095:Point-of-Care Systems / Q000592:standards*; D012016:Reference Values
chemical_list: D006442:Glycated Hemoglobin
keywords: hemoglobin A1c; laboratory analyzers; point-of-care testing devices; standardization