HbA1c is a major test in the medical laboratory because the test result is of conclusive relevance for diagnosis and treatment of diabetes, a high prevalence chronic disease. Therefore, the quality of the test is of utmost clinical importance. The impact of bias and imprecision will be discussed and requirements for diagnosis and monitoring treatment be derived from the IFCC model for quality targets.
To demonstrate the present status of HbA1c tests, the outcome of EurA1c and the international PT trial with participation of more than 5000 labs in 20 countries will be shown.
HbA1c is routinely used in the clinical laboratory to diagnose and monitor diabetes mellitus. Many methods have been standardized to provide precise and accurate results for normal patients. For the other common Hb variants, most of the methods are now relatively free of analytical interference.