RESUMO
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.
