Development and Multicenter Evaluation of the N Latex CDT Direct Immunonephelometric Assay for Serum Carbohydrate-Deficient Transferrin

Carbohydrate-deficient transferrin (CDT) is a promising biomarker of alcohol abuse. We describe the development and multicenter evaluation of N Latex CDT (Dade Behring), an automated, particle-enhanced, homogeneous immunonephelometric assay for directly determining CDT. N Latex CDT uses a monoclonal...

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Veröffentlicht in:Clinical chemistry (Baltimore, Md.) Md.), 2007-06, Vol.53 (6), p.1115-1121
Hauptverfasser: Delanghe, Joris R, Helander, Anders, Wielders, Jos P.M, Pekelharing, J. Maurits, Roth, Heinz J, Schellenberg, Francois, Born, Catherine, Yagmur, Eray, Gentzer, Wolfgang, Althaus, Harald
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container_issue 6
container_start_page 1115
container_title Clinical chemistry (Baltimore, Md.)
container_volume 53
creator Delanghe, Joris R
Helander, Anders
Wielders, Jos P.M
Pekelharing, J. Maurits
Roth, Heinz J
Schellenberg, Francois
Born, Catherine
Yagmur, Eray
Gentzer, Wolfgang
Althaus, Harald
description Carbohydrate-deficient transferrin (CDT) is a promising biomarker of alcohol abuse. We describe the development and multicenter evaluation of N Latex CDT (Dade Behring), an automated, particle-enhanced, homogeneous immunonephelometric assay for directly determining CDT. N Latex CDT uses a monoclonal antibody that recognizes the structure of transferrin glycoforms lacking 1 or 2 complete N-glycans [i.e., disialo-, monosialo-, and asialotransferrins (CDT glycoforms)] in combination with a simultaneous assay for total transferrin. The Dade Behring BN II and BN ProSpec systems automatically calculate the CDT value as a percentage of total transferrin (%CDT). No preanalytical sample treatment is used. Total imprecision values for serum pools containing 1.8%-8.7% CDT were 3.4%-10.4% (mean, 6.8%). The mean (SD) %CDT for 561 serum samples from healthy control individuals was 1.76% (0.27%; range, 1.01%-2.85%). No marked sex or age differences were noted. The 97.5th percentile was at 2.35%. Transferrin genetic variants did not interfere with measurements. High transferrin concentrations did not falsely increase %CDT values, but increased %CDT values were noted for some samples with transferrin concentrations
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N Latex CDT uses a monoclonal antibody that recognizes the structure of transferrin glycoforms lacking 1 or 2 complete N-glycans [i.e., disialo-, monosialo-, and asialotransferrins (CDT glycoforms)] in combination with a simultaneous assay for total transferrin. The Dade Behring BN II and BN ProSpec systems automatically calculate the CDT value as a percentage of total transferrin (%CDT). No preanalytical sample treatment is used. Total imprecision values for serum pools containing 1.8%-8.7% CDT were 3.4%-10.4% (mean, 6.8%). The mean (SD) %CDT for 561 serum samples from healthy control individuals was 1.76% (0.27%; range, 1.01%-2.85%). No marked sex or age differences were noted. The 97.5th percentile was at 2.35%. Transferrin genetic variants did not interfere with measurements. High transferrin concentrations did not falsely increase %CDT values, but increased %CDT values were noted for some samples with transferrin concentrations &lt;1.1 g/L. 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source MEDLINE; Oxford University Press Journals All Titles (1996-Current)
subjects Adolescent
Alcoholism
Alcoholism - diagnosis
Analytical, structural and metabolic biochemistry
Animals
Antibodies, Monoclonal - biosynthesis
Autoanalysis
Biological and medical sciences
Biomarkers - blood
Child
Congenital diseases
Congenital Disorders of Glycosylation - diagnosis
False Positive Reactions
Female
Fundamental and applied biological sciences. Psychology
Genetic markers
Genetic variance
Genetic Variation
Glycosylation
Humans
Immunoassay
Immunoassays
Investigative techniques, diagnostic techniques (general aspects)
Latex
Liquid chromatography
Male
Medical sciences
Methods
Mice
Mice, Inbred BALB C
Monoclonal antibodies
Nephelometry and Turbidimetry
Reference Values
Sensitivity and Specificity
Testing
Transferrin - analogs & derivatives
Transferrin - analysis
Transferrin - genetics
Transferrin - immunology
title Development and Multicenter Evaluation of the N Latex CDT Direct Immunonephelometric Assay for Serum Carbohydrate-Deficient Transferrin
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