title: Accuracy Assessment of Three Different Lots of the LABGEO PT Hemoglobin A1c Test Using Reference Materials.
abstract: BACKGROUND
  Both accurate measurement of HbA1c and minimal reagent lot-to-lot variability are essential for point-of-care HbA1c assays. The accuracy of three different cartridge lots of the Samsung LABGEO PT HbA1c Test was investigated to determine whether the results can be used for follow-up and screening of patients with diabetes.
  
  
  METHODS
  The LABGEO PT10 device and three different lots of the LABGEO PT HbA1c Test cartridge were used. Seven levels of reference materials were measured using each cartridge in a duplicate manner for 3 days. The bias, within-laboratory precision, and total error were calculated. The medical decision point analysis was performed.
  
  
  RESULTS
  The mean absolute bias, within-laboratory precision, and total error of each cartridge were 3.3%, 2.5%, and 8.1% for Lot1; 1.9%, 2.6%, and 7.1% for Lot2; and 2.7%, 2.8%, and 8.1% for Lot3. The predicted value (95% confidence interval) of each cartridge at an HbA1c of 6.5% was 6.74% (6.66, 6.83) for Lot1, 6.60 (6.51, 6.70) for Lot2, and 6.51 (6.39, 6.63) for Lot3.
  
  
  CONCLUSIONS
  Our data suggest that the LABGEO PT HbA1c Test can be used to monitor patients with diabetes and perform diabetes screening when false-positive results are obtained in the doctor's office.
authors.affiliation: Department of Laboratory Medicine, College of Medicine, St. Paul's Hospital, The Catholic University of Korea, Seoul.
authors.forename: Tae-Dong
authors.initials: TD
authors.lastname: Jeong
authors.affiliation: Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul.
authors.forename: Eun-Jung
authors.initials: EJ
authors.lastname: Cho
authors.affiliation: Health & Medical Equipment Business Team, Samsung Electronics Co., Ltd. Suwon.
authors.forename: Yunee
authors.initials: Y
authors.lastname: Shim
authors.affiliation: Health & Medical Equipment Business Team, Samsung Electronics Co., Ltd. Suwon.
authors.forename: Beom Seok
authors.initials: BS
authors.lastname: Lee
authors.affiliation: Health & Medical Equipment Business Team, Samsung Electronics Co., Ltd. Suwon.
authors.forename: Sungha
authors.initials: S
authors.lastname: Park
authors.affiliation: Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul.
authors.forename: Dae-Hyun
authors.initials: DH
authors.lastname: Ko
authors.affiliation: Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul.
authors.forename: Woochang
authors.initials: W
authors.lastname: Lee
authors.affiliation: Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul.
authors.forename: Sail
authors.initials: S
authors.lastname: Chun
authors.affiliation: Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
authors.forename: Junghan
authors.initials: J
authors.lastname: Song
authors.affiliation: Department of Laboratory Medicine, College of Medicine, St. Paul's Hospital, The Catholic University of Korea, Seoul.
authors.forename: Hi Jeong
authors.initials: HJ
authors.lastname: Kwon
authors.affiliation: Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul wkmin@amc.seoul.kr.
authors.forename: Won-Ki
authors.initials: WK
authors.lastname: Min
mesh_terms: D000066491:Clinical Decision-Making; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012015:Reference Standards
chemical_list: D006442:Glycated Hemoglobin; D011933:Reagent Kits, Diagnostic
keywords: accuracy; hemoglobin A1c; lot-to-lot variability; point-of-care