This is a study of diagnostic test accuracy in individuals referred to the Clinical Pathology Department for oral glucose tolerance testing. After fasting overnight, HbA(1c), fasting plasma glucose and 2-h plasma glucose were measured. The receiver operating characteristic curve was used to evaluate the diagnostic performance of HbA(1c). Four hundred and ninety-eight subjects (195 male, mean age 56 years) were enrolled and 115 (23.1%) were diagnosed with diabetes according to glucose-based methods and only 56 (11.2%) individuals were identified by HbA(1c) ≥ 6.5% (48 mmol/mol) (sensitivity 20.9%, specificity 95.3%). There is poor agreement between the newly recommended criterion and the current glucose-based diagnostic criteria (κ = 0.217; P<0.001), probably because the diagnostic methods identify different populations of patients. Adding a glucose-based method into an algorithm, as proposed by the UK Department of Health, improved HbA(1c) performance.
HbA(1c) ≥ 6.5% (48 mmol/mol) showed limited sensitivity to diabetes diagnosis, although with high specificity. The results suggest that this cut-off point would not be enough to diagnose diabetes. Its use as the sole diabetes diagnostic test should be interpreted with caution to assure the correct classification of diabetic individuals.
HbA(1c) measurement for the diagnosis of diabetes: is it enough?