Multicenter evaluation of an enzymatic method for glycated albumin

R. Paleari, G. Bonetti, C. Callà, M. Carta, F. Ceriotti, N. Di Gaetano, M. Ferri, E. Guerra, G. Lavalle, C.L. Cascio, F.G. Martino, M. Montagnana, M. Moretti, G. Santini, D. Scribano, R. Testa, A. Vero, A. Mosca

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Background The use of glycated albumin (GA) has been proposed as an additional glycemic control marker particularly useful in intermediate-term monitoring and in situation when HbA1c test is not reliable. Methods We have performed the first multicenter evaluation of the analytical performance of the enzymatic method quantILab Glycated Albumin assay implemented on the most widely used clinical chemistry analyzers (i.e. Abbott Architect C8000, Beckman Coulter AU 480 and 680, Roche Cobas C6000, Siemens ADVIA 2400 and 2400 XPT). Results The repeatability of the GA measurement (expressed as CV, %) implemented in the participating centers ranged between 0.9% and 1.2%. The within-laboratory CVs ranged between 1.2% and 1.6%. A good alignment between laboratories was found, with correlation coefficients from 0.996 to 0.998. Linearity was confirmed in the range from 7.6 to 84.7%. Conclusion The new enzymatic method for glycated albumin evaluated by our investigation is suitable for clinical use. © 2017 Elsevier B.V.
Original languageUndefined/Unknown
Pages (from-to)81-86
Number of pages6
JournalClinica Chimica Acta
Volume469
DOIs
Publication statusPublished - 2017

Keywords

  • glycosylated albumin
  • enzyme
  • glycosylated serum albumin
  • serum albumin, Article
  • chemical analyzer
  • colorimetry
  • correlation coefficient
  • enzymatic assay
  • human
  • intermethod comparison
  • measurement repeatability
  • protein determination
  • blood analysis
  • clinical trial
  • evaluation study
  • metabolism
  • multicenter study
  • procedures
  • reproducibility
  • statistical model, Blood Chemical Analysis
  • Enzymes
  • Humans
  • Linear Models
  • Reproducibility of Results
  • Serum Albumin

Cite this

Multicenter evaluation of an enzymatic method for glycated albumin. / Paleari, R.; Bonetti, G.; Callà, C.; Carta, M.; Ceriotti, F.; Di Gaetano, N.; Ferri, M.; Guerra, E.; Lavalle, G.; Cascio, C.L.; Martino, F.G.; Montagnana, M.; Moretti, M.; Santini, G.; Scribano, D.; Testa, R.; Vero, A.; Mosca, A.

In: Clinica Chimica Acta, Vol. 469, 2017, p. 81-86.

Research output: Contribution to journalArticle

Paleari, R, Bonetti, G, Callà, C, Carta, M, Ceriotti, F, Di Gaetano, N, Ferri, M, Guerra, E, Lavalle, G, Cascio, CL, Martino, FG, Montagnana, M, Moretti, M, Santini, G, Scribano, D, Testa, R, Vero, A & Mosca, A 2017, 'Multicenter evaluation of an enzymatic method for glycated albumin', Clinica Chimica Acta, vol. 469, pp. 81-86. https://doi.org/10.1016/j.cca.2017.03.028
Paleari, R. ; Bonetti, G. ; Callà, C. ; Carta, M. ; Ceriotti, F. ; Di Gaetano, N. ; Ferri, M. ; Guerra, E. ; Lavalle, G. ; Cascio, C.L. ; Martino, F.G. ; Montagnana, M. ; Moretti, M. ; Santini, G. ; Scribano, D. ; Testa, R. ; Vero, A. ; Mosca, A. / Multicenter evaluation of an enzymatic method for glycated albumin. In: Clinica Chimica Acta. 2017 ; Vol. 469. pp. 81-86.
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abstract = "Background The use of glycated albumin (GA) has been proposed as an additional glycemic control marker particularly useful in intermediate-term monitoring and in situation when HbA1c test is not reliable. Methods We have performed the first multicenter evaluation of the analytical performance of the enzymatic method quantILab Glycated Albumin assay implemented on the most widely used clinical chemistry analyzers (i.e. Abbott Architect C8000, Beckman Coulter AU 480 and 680, Roche Cobas C6000, Siemens ADVIA 2400 and 2400 XPT). Results The repeatability of the GA measurement (expressed as CV, {\%}) implemented in the participating centers ranged between 0.9{\%} and 1.2{\%}. The within-laboratory CVs ranged between 1.2{\%} and 1.6{\%}. A good alignment between laboratories was found, with correlation coefficients from 0.996 to 0.998. Linearity was confirmed in the range from 7.6 to 84.7{\%}. Conclusion The new enzymatic method for glycated albumin evaluated by our investigation is suitable for clinical use. {\circledC} 2017 Elsevier B.V.",
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T1 - Multicenter evaluation of an enzymatic method for glycated albumin

AU - Paleari, R.

AU - Bonetti, G.

AU - Callà, C.

AU - Carta, M.

AU - Ceriotti, F.

AU - Di Gaetano, N.

AU - Ferri, M.

AU - Guerra, E.

AU - Lavalle, G.

AU - Cascio, C.L.

AU - Martino, F.G.

AU - Montagnana, M.

AU - Moretti, M.

AU - Santini, G.

AU - Scribano, D.

AU - Testa, R.

AU - Vero, A.

AU - Mosca, A.

PY - 2017

Y1 - 2017

N2 - Background The use of glycated albumin (GA) has been proposed as an additional glycemic control marker particularly useful in intermediate-term monitoring and in situation when HbA1c test is not reliable. Methods We have performed the first multicenter evaluation of the analytical performance of the enzymatic method quantILab Glycated Albumin assay implemented on the most widely used clinical chemistry analyzers (i.e. Abbott Architect C8000, Beckman Coulter AU 480 and 680, Roche Cobas C6000, Siemens ADVIA 2400 and 2400 XPT). Results The repeatability of the GA measurement (expressed as CV, %) implemented in the participating centers ranged between 0.9% and 1.2%. The within-laboratory CVs ranged between 1.2% and 1.6%. A good alignment between laboratories was found, with correlation coefficients from 0.996 to 0.998. Linearity was confirmed in the range from 7.6 to 84.7%. Conclusion The new enzymatic method for glycated albumin evaluated by our investigation is suitable for clinical use. © 2017 Elsevier B.V.

AB - Background The use of glycated albumin (GA) has been proposed as an additional glycemic control marker particularly useful in intermediate-term monitoring and in situation when HbA1c test is not reliable. Methods We have performed the first multicenter evaluation of the analytical performance of the enzymatic method quantILab Glycated Albumin assay implemented on the most widely used clinical chemistry analyzers (i.e. Abbott Architect C8000, Beckman Coulter AU 480 and 680, Roche Cobas C6000, Siemens ADVIA 2400 and 2400 XPT). Results The repeatability of the GA measurement (expressed as CV, %) implemented in the participating centers ranged between 0.9% and 1.2%. The within-laboratory CVs ranged between 1.2% and 1.6%. A good alignment between laboratories was found, with correlation coefficients from 0.996 to 0.998. Linearity was confirmed in the range from 7.6 to 84.7%. Conclusion The new enzymatic method for glycated albumin evaluated by our investigation is suitable for clinical use. © 2017 Elsevier B.V.

KW - glycosylated albumin

KW - enzyme

KW - glycosylated serum albumin

KW - serum albumin, Article

KW - chemical analyzer

KW - colorimetry

KW - correlation coefficient

KW - enzymatic assay

KW - human

KW - intermethod comparison

KW - measurement repeatability

KW - protein determination

KW - blood analysis

KW - clinical trial

KW - evaluation study

KW - metabolism

KW - multicenter study

KW - procedures

KW - reproducibility

KW - statistical model, Blood Chemical Analysis

KW - Enzymes

KW - Humans

KW - Linear Models

KW - Reproducibility of Results

KW - Serum Albumin

U2 - 10.1016/j.cca.2017.03.028

DO - 10.1016/j.cca.2017.03.028

M3 - Articolo

VL - 469

SP - 81

EP - 86

JO - Clinica Chimica Acta

JF - Clinica Chimica Acta

SN - 0009-8981

ER -