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1
Department of Clinical Biochemistry, The Royal London Hospital, Whitechapel, London E1 1BB, UK.
2
Biochemistry Laboratory, Henri Mondor Hospital, 94010
Creteil, France.
3
Central Laboratory, Ziekenhuis De Weezenlande, 8011 JW
Zwolle, The Netherlands.
4
Department of Hematology, Hospital de la Valle Hebron,
08035 Barcelona, Spain.
5
Anti Diabetic Centre, S. Michele Hospital, Via Peretti,
(09100) Cagliari, Italy.
a Author for correspondence. Fax +44 171 377 7777.
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 <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).
Key Words: indexing terms: diabetes mellitus • hemoglobin variants • HPLC • immunoassay.
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