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Comparative Study
. 2015 Mar;9(2):192-9.
doi: 10.1177/1932296814567894. Epub 2015 Jan 14.

Analytical evaluation of the Diazyme glycated serum protein assay on the siemens ADVIA 1800: comparison of results against HbA1c for diagnosis and management of diabetes

Karina Rodriguez-Capote  1 , Kayla Tovell  2 , Deborah Holmes  2 , Janice Dayton  2 , Trefor N Higgins  3
Affiliations
Comparative Study

Analytical evaluation of the Diazyme glycated serum protein assay on the siemens ADVIA 1800: comparison of results against HbA1c for diagnosis and management of diabetes

Karina Rodriguez-Capote et al. J Diabetes Sci Technol. 2015 Mar.

Abstract

Hemoglobin A1c (HbA1c) is considered the gold standard for assessment of glycemic control in diabetic patients. HbA1c is inadequate in individuals homozygous or compound heterozygous for hemoglobin variants or in conditions with an altered red blood cell turnover. In these cases glycated albumin (GA) is proposed as an alternative assay. We aimed to evaluate the analytical performance of the Diazyme glycated serum protein (GSP) assay on an automated analyzer, to establish a reference interval (RI), and to compare from a clinical perspective, GSP/GA with glycated Hb (glyHb) results. Validation studies followed the CLSI guidelines and included precision, linearity, interferences, concordance of results with glyHb, and RI calculation. GSP was analyzed on representative samples with previously ordered HbA1c and albumin from the Dyna LIFE : DX laboratory. Samples from patients with bisalbuminemia, hemoglobinopathies, and multiple myeloma were also included. Within-run and total imprecision was <3.0% at both levels of control, analytical sensitivity was 5.31 μmol/L, and linearity was verified from 10 to 1150 μmol/L (total allowable error of 5%). Clinical concordance between %GA and glyHb was substantial (n = 175, R2 = .91, kappa = .78, P = .167). GSP RI was 160 to 340 μmol/L or if expressed as %GA 10.5 to 17.5%. Analytical performance of the Diazyme GSP assay on the Siemens ADVIA 1800 is acceptable for clinical use. The RI obtained was higher than that suggested by the manufacturer.

Keywords: diabetes mellitus; glycated albumin; glycated hemoglobin; glycated protein; glycemic markers; hemoglobin A1c.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Frequency histograms summarizing the distribution of HbA1c (glyHb) and %GA results in the study population. Normal distribution plot (mean and standard deviation of the data represented in the histogram) is superimposed over the histogram. In the absence of HbA, glyHb was obtained immunochemically.
Figure 2.
Figure 2.
Box and whisker plots of the %GA distribution. The central box represents the values from the 25 to 75 percentile. The middle line represents the median; the horizontal line represents the minimum and the maximum values, excluding outside and far-out values, which are displayed as separate points.
Figure 3.
Figure 3.
Scatter diagram with results from all patient samples including diabetic, nondiabetic, and those with bisalbuminemia and hemoglobinopathies. Deming regression line (solid line), identity line (x = y, dotted line), upper limit of HbA1c RI (vertical dash-dotted line), upper limit of %GA RI (horizontal dash-dotted line).
Figure 4.
Figure 4.
Method comparison between the Diazyme assay (%GA calculated) and Lucica GA-L assay. (A) Least squares regression (solid line), identity line (x = y, dotted line), 95% prediction interval for the regression line (dashed line). (B) Bland–Altman plot, scatter diagram of the differences plotted against the Lucica GA-L method (reference method).
See this image and copyright information in PMC

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