Background: A project for the standardization of HbA2 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 HbA2. 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 HbA2, together with a brief preliminary presentation of the proposed primary reference measurement procedure based on ID-MS are outlined.
Keywords: HbA2; standardization; traceability; β-thalassemia.