Impact of ISO/TS 20914-based measurement uncertainty on HbA1c diagnostic classification: A real-world comparison of two analytical systems.
OBJECTIVES HbA1c is interpreted using fixed clinical decision limits, but measurement uncertainty (MU) may affect analytical interpretation of results near these thresholds. This study estimated ISO/TS 20914-based MU for two HbA1c analytical systems and evaluated the patient-level impact of including calibration- and t...