Performance characteristics and clinical utility of an enzymatic method for the measurement of glycated albumin in plasma
Articolo
Data di Pubblicazione:
2007
Citazione:
Performance characteristics and clinical utility of an enzymatic method for the measurement of glycated albumin in plasma / R. Paroni, F. Ceriotti, R. Galanello, G.B. Leoni, A. Panico, E. Scurati, R. Paleari, L. Chemello, V. Quaino, L. Scaldaferri, A. Lapolla, A. Mosca. - In: CLINICAL BIOCHEMISTRY. - ISSN 0009-9120. - 40:18(2007 Aug 10), pp. 1398-1405.
Abstract:
Objective: The measurement of plasma glycated albumin is particularly useful in the short-middle term monitoring of glycometabolic control
in diabetics. The aim of this work is to evaluate a new enzymatic method for the measurement of glycated albumin in plasma, with particular
attention to some selected cases and comparison with other relevant tests (fasting plasma glucose, after glucose load, fructosamine, glycated
hemoglobin).
Design and methods: We have performed a multicenter study by which sample collection was performed in three different centers (Milano,
Padova and Cagliari) and serum samples, frozen at −80 °C, were then delivered under dry ice to the centralized laboratory in Milano. Glycated
plasma albumin was measured with reagents from Asahi Kasei Pharma (Lucica GA-L enzymatic assay; AKP, Tokyo, Japan) on a Modular P
Roche system. Fructosamine was assessed by a Roche method and HbA1c (measured separately in the three centers on fresh EDTA blood) by
DCCT-aligned HPLC systems. We have investigated 50 type 2 diabetics, 26 subjects with gestational diabetes, 35 subjects with thalassemia major,
10 subjects with cirrhosis, 23 patients with end-stage renal disease subjected to dialysis treatment and 32 healthy adult control subjects.
Results: The main analytical performance characteristics of the new GA test were the following: (a) the within-assay reproducibility was
between 3.0 and 3.9% (in terms of GA% CV, measured on 2 serum pools and 2 control materials at normal and pathological glycated albumin
levels); (b) the between-assays reproducibility was from 2.8 to 4.1%; (c) the linearity was tested in the interval between 13 and 36% and found
acceptable (r2=0.9932). Concerning the clinical utility of the new test, we have evaluated the relationships between GA, HbA1c, fructosamine and
fasting and post-prandial glucose in several patients, as well as the changes in the abovementioned parameters in a sub-group of type 2 diabetic
patients for 18 weeks as they progressed from severe hyperglycemia (HbA1c ≥10.0%) toward a better glycemic control. The correlations between
glycated albumin and HbA1c were as follows: (a) type 2 diabetics: r2=0.483 (good glycemic control), r2=0.577 (poor control); (b) diabetic
patients under dialysis: r2=0.480; (c) liver disease: r2=0.186; (d) transfused non-diabetics with thalassemia: r2=0.004. Glycated albumin, as well
as HbA1c and fructosamine, was of little value in the study of women with gestational diabetes, mainly because of the very limited glucose
fluctuations in this particular category of subjects. In 11 type 2 diabetic patients under poor metabolic control, GA was better correlated with
fasting plasma glucose then HbA1c (r2=0.555 vs. 0.291, respectively), and decreased more rapidly than HbA1c during intensive insulin therapy.
Conclusions: The experience we have acquired with the new enzymatic test demonstrates its reproducibility and robustness. We confirm that
plasma glycated albumin is better related to fasting plasma glucose with respect to HbA1c. Moreover, glycated albumin is more sensitive than
HbA1c with regard to short-term variations of glycemic control during treatment of diabetic patients. This test is also very appropriate when the
interpretation of HbA1c is critical.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
Glycated albumin ; Diabetes ; Enzymatic assay ; Glycated hemoglobin
Elenco autori:
R. Paroni, F. Ceriotti, R. Galanello, G.B. Leoni, A. Panico, E. Scurati, R. Paleari, L. Chemello, V. Quaino, L. Scaldaferri, A. Lapolla, A. Mosca
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