Background: Most of the current methods used for the determination of HbA2 seem not well aligned. A comparison among the best performing techniques and the commutability of some control materials currently available and under development has been evaluated.
Methods: Forty blood samples were analyzed in duplicate over two separate days by different HPLC and capillary electrophoresis systems. The commutabilities of different control materials (NIBSC WHO reagent, Bio-Rad Lyphochek, and home prepared lyophilized controls RP1-3) have been assessed by analyzing the controls in quadruplicate over two consecutive days together with the blood samples.
Results: The mean within-run imprecision of HbA2 measurement on blood samples (CV, %) was between 0.6% and 10.1% for HbA2 values <3.5%, and between 1.1 and 3.1 for HbA2≥3.5%. The different methods were highly correlated (r between 0.9941 and 0.9995) although biased each other. The NIBSC WHO reagent was found not commutable in 15 over 28 comparisons, the Lyphochek 2 in 18/28, and RP3 in 4/28. Recalibration of all methods by RP1 and RP2 materials was able to reduce the overall variability from 6.8% to 3.4% at HbA2≤3.0% and from 6.7% to 3.0% at HbA2≥4.6%.
Conclusion: The use of adequate commutable control materials as calibrators may reduce the inter-method variability of routine methods to an extent closer to the current analytical goals of bias based on biological variability.
Keywords: Commutability; Harmonization; HbA(2); Multicenter evaluation; Standardization; β-Thalassemia.
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