Evaluation of the Menarini–Arkray HA 8140 hemoglobin A1c analyzer

作者: W Garry John , Francois Braconnier , Kor Miedema , Carlos Aulesa , Giampiero Piras

DOI: 10.1093/CLINCHEM/43.6.968

关键词:

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

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