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 <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).

Haemoglobin Kenitra detected by HPLC assay and its compromising effect on the measurement of HbA1c

“…Currently, HPLC is the method of choice for detecting abnormal haemoglobin variants and quantifying Hb A2 and Hb foetal. The estimation of HbA 1c is the standard method for monitoring long-term glucose levels in diabetic patients [11], but it is significant that it is unreliable in the presence of certain rare variants, as in our case. An alternative method to better monitor diabetic patients with haemoglobin variants should be proposed.…”

Haemoglobin Etobicoke, an incidental finding in an Irish diabetic

“…A number of haemoglobin variants have been described in the literature as interfering with the quantification of glycated haemoglobin (Elder et al, 1998;Tsai et al, 2001;Lahoussen et al, 2002). It is also known that commonly detected haemoglobin variants, such as HbS, HbC and HbF, allow a reliable assessment of HbA 1c using this method (John et al, 1997). The variant haemoglobin flag generated by the Menarini HA 8140 does not distinguish between these commonly occurring variants and less common or rare haemoglobin variants.…”

“…The use of glycated haemoglobin (HbA 1c ) to assess glycaemic control of diabetes mellitus is now widespread and central to the management of diabetic patients (John et al, 1997). The advent of automated HbA 1c monitoring using HPLC means that population groups that hitherto have not been screened for haemoglobin variants are yielding some unexpected findings.…”

Separation of haemoglobin HbE and HbA2 by the fully automated, high‐pressure liquid chromatography Tosoh HLC‐723 G7 analyzer

“…Within-run CVs for both normal and raised HbA 2 levels were found always below 2.2% (Paleari et al, 2005). The HA-8160 is a compact, compact fully automated haemoglobin analyzer based on reversedphase cation-exchange chromatography which uses two different protocols for performing diabetes monitoring as well as b-thal screening (John et al, 2002). Haemoglobin samples were also separated on agarose gels by use of the Beckman Paragon Alkaline Hemo-Ó 2007 Blackwell Publishing Ltd, Int.…”