Standardization of method for determining glycosylated hemoglobin (Hb A1c) by cation exchange high performance liquid chromatography

Hemoblobin A(1)c is the most important parameter for the monitoring of metabolic control of patients with diabetes mellitus. The purpose of this study was to adapt the Mono S method to a conventional HPLC system, allowing highly selective HbA(1)c determination without the acquisition of kits or the use of dedicated systems The results obtained were compared to the Tinaquant (R) immune turbidimetric method and the Bio-Rad Variant (R) chromatographic method. The developed method presented intra-study precision (C.V.%) of 1.39-3.65 and inter-study precision (C.V.%) of 2.80-3.02%. The determination coefficients among methods were: HPLC Mono S x Tinaquant (R): 0.9856 (n=60) and HPLC Mono S x HPLC Bio-Rad Variant (R):r(2): 0.9806 (n=16). A conversion equation between HPLC Mono S and Bio-Rad Variant (R) was calculated allowing yielding comparable and interchangeable values. The H PLC Mono-S is a precise, low-cost method which yields similar values to the Bio-Rad Variant (R) method on conventional HPLC equipment.