HbA1c standardisation destination--global IFCC Standardisation. How, why, where and when--a tortuous pathway from kit manufacturers, via inter-laboratory lyophilized and whole blood comparisons to designated national comparison schemes.

Abstract

Glycohaemoglobins were first used in routine clinical laboratories for diabetes monitoring around 1977 and at the time all methods had either no calibrators, or used material with assayed values derived from individual manufacturers' assays. Over the next five to fifteen years, lyophilised and whole blood sample exchanges were shown to improve inter-laboratory variability markedly. The use of a precise HPLC method as the "standard method" in the Diabetes Control and Complications Trial (DCCT) led to significant further improvement. National standardisation schemes in the mid to late 1990s in the USA, Japan and Sweden further improved the quality and accuracy of HbA1c assays in clinical use. The work of the IFCC Working Group on Standardisation of HbA1c in establishing true International Reference Methods for HbA1c and the successful preparation of pure HbA1c calibration material should lead to further improvements in inter-method and inter-laboratory variability, essential to the long-term monitoring of patients with diabetes.