Reference Intervals for Hemoglobin A1c in Pregnant Women: Data from an Italian Multicenter Study

Mosca, Andrea; Paleari, Renata; Dalfrà, Maria Grazia; Cianni, Graziano Di; Cuccuru, Ilaria; Pellegrini, Giovanni; Malloggi, Lucia; Bonomo, Matteo; Granata, Simona; Ceriotti, Ferruccio; Castiglioni, M.; Songini, Marco; Tocco, G.; Masin, M.; Plebani, Mario; Lapolla, Annunziata

doi:10.1373/clinchem.2005.064899

Cited by 135 publications

(79 citation statements)

References 32 publications

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“…on the Pool, Level 1 in the within-run experiment), and slightly higher CV i values were found in the other specimen in the within-and between-run imprecision studies. These results can be compared to the analytical quality of the HbA 1c measurements in our laboratories, which is in the order of 2.0%, as CV, as previously reported [18].…”

Section: Discussionmentioning

confidence: 52%

“…In group 1, 2 and 4, samples for post-prandial (1 hr after lunch) plasma glucose were also collected. Glucose measurements were performed directly in the three centers by enzymatic methods [18]. The remaining plasma aliquots were immediately frozen, stored at − 80°C and sent within 3 months to the centralized laboratory in Milano for GA and fructosamine quantification.…”

Section: Laboratory Measurementsmentioning

confidence: 99%

“…A separate set of EDTA-blood samples was collected, stored and shipped in the same condition for measuring the HbA 1c concentrations to the same centralized laboratory in Milano. HbA 1c was measured by HPLC using an automated system (Bio-Rad Variant II dual kit, Bio-Rad Laboratories, Segrate, Milano) aligned to the DCCT method, as previously described [18].…”

Section: Laboratory Measurementsmentioning

confidence: 99%

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Performance characteristics and clinical utility of an enzymatic method for the measurement of glycated albumin in plasma

Paroni

Ceriotti

Galanello

et al. 2007

Clinical Biochemistry

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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 HbA 1c (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 (r 2 = 0.9932). Concerning the clinical utility of the new test, we have evaluated the relationships between GA, HbA 1c , 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 (HbA 1c ≥10.0%) toward a better glycemic control. The correlations between glycated albumin and HbA 1c were as follows: (a) type 2 diabetics: r 2 = 0.483 (good glycemic control), r 2 = 0.577 (poor control); (b) diabetic patients under dialysis: r 2 = 0.480; (c) liver disease: r 2 = 0.186; (d) transfused non-diabetics with thalassemia: r 2 = 0.004. Glycated albumin, as well as HbA 1c 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 HbA 1c (r 2 = 0.555 vs. 0.291, respectively), and decreased more rapidly than HbA 1c 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 resp...

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Section: Discussionmentioning

confidence: 52%

Section: Laboratory Measurementsmentioning

confidence: 99%

Section: Laboratory Measurementsmentioning

confidence: 99%

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Performance characteristics and clinical utility of an enzymatic method for the measurement of glycated albumin in plasma

Paroni

Ceriotti

Galanello

et al. 2007

Clinical Biochemistry

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“…46 Glycemic control can also be evaluated by measuring HbA 1c . Although standardized measurements have shown that HbA 1c levels are significantly higher in GDM patients than in normal pregnant women, 47 the association between HbA 1c levels and pregnancy outcome in these patients is weak. 48,49 When considering HbA 1c levels in diabetic pregnant patients, we must refer to the values for normal pregnant women (which are lower than in women who are not pregnant) 47,50 and standardized methods are needed to obtain valid results.…”

Section: Dovepressmentioning

confidence: 97%

Management of gestational diabetes mellitus

Lapolla¹,

Fedele²,

Dalfra³

2009

DMSO

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“…La DG se asocia a complicaciones maternas y perinatales, siendo la macrosomía la más frecuente [5][6][7] . La detección precoz de la DG es un pilar fundamental en el control obstétrico de la mujer embarazada, y se ha demostrado que un estricto control glicémico durante el período de gestación mejora la calidad del embarazo y reduce sustancialmente los riesgos materno-fetales a tasas similares a las observadas en mujeres no diabéticas 2,8,9 . Las mediciones de glicemia pueden fl uctuar, es por eso que desde hace varios años se ha estado trabajando en el estudio de marcadores que refl ejen más fi elmente el estado real del control glicémico de la paciente 10 .…”

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Utilidad de la medición de fructosamina como indicador de control en pacientes con diabetes gestacional y pregestacional

M¹,

et al. 2011

Rev. méd. Chile

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Reference Intervals for Hemoglobin A1c in Pregnant Women: Data from an Italian Multicenter Study

Cited by 135 publications

References 32 publications

Performance characteristics and clinical utility of an enzymatic method for the measurement of glycated albumin in plasma

Performance characteristics and clinical utility of an enzymatic method for the measurement of glycated albumin in plasma

Management of gestational diabetes mellitus

Utilidad de la medición de fructosamina como indicador de control en pacientes con diabetes gestacional y pregestacional

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