Evaluation of the Menarini–Arkray HA 8140 hemoglobin A1c analyzer

Abstract
We describe a multinational evaluation of the Menarini– Arkray HA 8140 hemoglobin (Hb) A1canalyzer, which utilizes a high degree of automation, including bar code reading, cap piercing, and whole-blood sampling. Within- and between-batch CVs were 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 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).

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