Evaluation of the Menarini-Arkray HA 8140 hemoglobin A(1c) analyzer

Abstract

We describe a multinational evaluation of the Menarini-Arkray HA 8140 hemoglobin (Hb) A(1c) analyzer, which utilizes a high degree of automation, including bar code reading, cap piercing, and whole-blood sampling. Within- 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 A(1c) 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 A(1c) 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).