EVALUATION OF THE MENARINI-ARKRAY HA-8140 HEMOGLOBIN A(1C) ANALYZER

We describe a multinational evaluation of the Menarini-Arkray HA 8140 hemoglobin (Hb) A(1c) analyzer, which utilizes a high degree of automa tion, including bar code reading, cap piercing, and whole-blood sampli ng, Within- and between-batch CVs were <2%. Linearity was confirmed th roughout the working range of the analyzer. Common Hb variants, includ ing Hb S, Hb C, and Hb F, did not interfere with the Hb A(1c) separati on, and the potentially interfering labile Schiff base was effectively removed during the chromatographic procedure. The HA 8140 analyzer di splayed good correlation to the Bio-Rad Variant analyzer, Tinaquant im munoassay, 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 (0.52, 1.01).