Clinical Chemistry and Laboratory Medicine (CCLM)
Translating analytical performance into clinical misclassification risk: a probabilistic framework for HbA 1c interpretation
Abstract Objectives Using HbA 1c for diabetes diagnosis directly links analytical uncertainty to patient classification. Since traditional performance metrics provide limited insight into these clinical implications, we developed a probabilistic framework to translate HbA 1c concentrations and components of analytical uncertainty into clinically interpretable diagnostic risk. Methods The framework was applied to 100,472 HbA 1c results obtained from a real-world Laboratory Information System. Analytical bias, analyt …