Accuracy assessment of three different lots of the LABGEO PT hemoglobin A1c test using reference materials

Tae Dong Jeong, Eun Jung Cho, Yunee Shim, Beom Seok Lee, Sungha Park, Dae Hyun Ko, Woochang Lee, Sail Chun, Junghan Song, Hi Jeong Kwon, Won Ki Min

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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, withinlaboratory 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.

Original languageEnglish
Pages (from-to)72-77
Number of pages6
JournalAnnals of Clinical and Laboratory Science
Volume46
Issue number1
StatePublished - 1 Jan 2016

Keywords

  • Accuracy
  • Hemoglobin A1c
  • Lot-to-lot variability
  • Point-of-care

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