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Clinical Chemistry 53: 1115-1121, 2007. First published April 5, 2007; 10.1373/clinchem.2006.084459
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Right arrow Automation and Analytical Techniques
(Clinical Chemistry. 2007;53:1115-1121.)
© 2007 American Association for Clinical Chemistry, Inc.

Automation and Analytical Techniques

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

Joris R. Delanghe1,a, Anders Helander2, Jos P.M. Wielders3, J. Maurits Pekelharing4, Heinz J. Roth5, François Schellenberg6, Catherine Born7, Eray Yagmur8, Wolfgang Gentzer9 and Harald Althaus9

1 Department of Clinical Chemistry, Ghent University Hospital, Ghent, Belgium.
2 Alcohol Laboratory, Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden.
3 Department of Clinical Chemistry, Meander Medical Center, Amersfoort, The Netherlands.
4 Reinier de Graaf Groep, Diagnostic Center SSDZ, Delft, The Netherlands.
5 Limbach Laboratories, Heidelberg, Germany.
6 Laboratory of Clinical Chemistry, Hopital Trousseau, Centre Hospitalier Régional Universitaire, Tours, Tours, France.
7 Institut Regional pour la Sante, La Riche, France.
8 Central Laboratory, University Hospital, Rheinisch Westfälische Technische Hochschule, Aachen, Germany.
9 Research Laboratories, Dade Behring Marburg GmbH, Marburg, Germany.

aAddress correspondence to this author at: Department of Clinical Chemistry, De Pintelaan 185, B-9000 Ghent, Belgium. Fax 32-9-240-4985; e-mail joris.delanghe{at}ugent.be.

Background: 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.

Methods: 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 IITM and BN ProSpec® systems automatically calculate the CDT value as a percentage of total transferrin (%CDT). No preanalytical sample treatment is used.

Results: 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 <1.1 g/L. N Latex CDT results correlated with those of a commercial CDT immunoassay involving column separation (r2 = 0.862) and an HPLC candidate reference method (r2 = 0.978).

Conclusion: N Latex CDT is the first direct immunoassay for quantifying %CDT in serum. The specificity of N Latex CDT for identifying alcohol abuse may be higher than for immunoassays that use column separation, because transferrin genetic variants do not interfere with measurements.




The following articles in journals at HighWire Press have cited this article:


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J. B. Whitfield, V. Dy, P. A.F. Madden, A. C. Heath, N. G. Martin, and G. W. Montgomery
Measuring Carbohydrate-Deficient Transferrin by Direct Immunoassay: Factors Affecting Diagnostic Sensitivity for Excessive Alcohol Intake
Clin. Chem., July 1, 2008; 54(7): 1158 - 1165.
[Abstract] [Full Text] [PDF]

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A. Helander and G. Nordin
Insufficient Standardization of a Direct Carbohydrate-Deficient Transferrin Immunoassay
Clin. Chem., June 1, 2008; 54(6): 1090 - 1092.
[Full Text] [PDF]


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