Evaluation of the Menarini-Arkray HA 8140 hemoglobin A1c analyzer

We describe a multinational evaluation of the Menarini-Arkray HA 8140 hemoglobin (Hb) A1c analyzer, which utilizes a high degree of automation, including bar code reading, cap piercing, and whole-blood sampling. With-in- and between-batch CVs were < 2%. Linearity was confirmed throughout the working range of the analyzer. Common Hb variants, including Hb S, Hb C, and Hb F, did not interfere with the Hb A1c separation, and the potentially interfering labile Schiff base was effectively removed during the chromatographic procedure. The HA 8140 analyzer displayed good correlation to the Bio-Rad Variant analyzer, Tinaquant immunoassay, affinity chromatography, and an optimized "in-house" HPLC Hb A1c method. The methods when compared by Altman and Bland plots showed bias (upper, lower 95% confidence limits) of: Variant minus HA 8140 = 0.99 (0.23, 1.74), Tinaquant minus HA 8140 = 0.14 (-0.71, 0.98); affinity minus HA 8140 (after log transformation) = 1.13 (0.90, 1.41), and "in house" HPLC minus HA 8140 (after log transformation) = 0.91 (0.82, 1.01).