Standardization of the HbA(2) Assay

BACKGROUND: A project for the standardization of HbA(2) was launched by the IFCC back in 2004. MATERIALS AND METHODS: In this work we report on the state-of-the-art of the project on standardization of HbA(2). Data obtained from various EQAS studies, and from previous experimental evaluations, are presented. RESULTS: We have proven that biases between various commercial methods are still currently significant. We have also shown that calibration by commutable control materials may halve the inter-method variability. CONCLUSIONS: The foundation of the reference system for HbA(2), together with a brief preliminary presentation of the proposed primary reference measurement procedure based on ID-MS are outlined.