Akademik Veri Yönetim Sistemi
Diagnostic Microbiology and Infectious Disease, cilt.114, sa.2, 2026 (SCI-Expanded)
This study calculated the measurement uncertainty (MU) of the anti-HBs, anti-rubella IgG, and anti-toxoplasma IgG assays according to the ISO/TS 20914:2019 guideline. Then, it evaluated the impact of MU on clinical interpretation. Analyses were performed using the Alinity i analyzer (Abbott Diagnostics), based on internal quality control (IQC) data from 2023 to 2024 and manufacturer-provided calibrator uncertainty values. The overall MU estimates were derived by combining the repeatability uncertainty (uRw) and the calibrator uncertainty (uCal) using the square root of the sum of squares method. Expanded uncertainty (U, k = 2) was calculated to provide 95 % coverage. For anti-HBs, the MU was 10 ± 17 mIU/mL at the 10 mIU/mL cutoff and 30 ± 18 mIU/mL at the 30 mIU/mL cutoff. For anti-rubella IgG, the MU was 10 ± 17 IU/mL and 30 ± 19 IU/mL, respectively. For anti-toxoplasma IgG, the MU was 3 ± 3.6 IU/mL at the 3 IU/mL cutoff and 8 ± 5 IU/mL at the 8 IU/mL cutoff. The mean CV values in 2023 and 2024 were 11.77 % and 11.26 % for anti-HBs; 17.83 % and 16.30 % for anti-rubella IgG; and 18.87 % and 21.43 % for anti-toxoplasma IgG. There was no significant interannual variation (p > 0.05). Integrating MU into serological reports creates an "uncertainty zone" around cut-off values, reducing the risk of misclassification and improving patient safety. To our knowledge, this is one of the first studies to demonstrate the routine application of MU estimation in quantitative serological assays, highlighting its potential value in clinical practice.