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

Delanghe, Joris; Helander, Anders; Wielders, Jos P.M.; Pekelharing, J.M.; Roth, Heinz Jürgen; Schellenberg, François; Born, Catherine; Yagmur, Eray; Gentzer, Wolfgang; Althaus, Harald

doi:10.1373/clinchem.2006.084459

Cited by 76 publications

(56 citation statements)

References 37 publications

(28 reference statements)

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“…Four HPLC methods were included: the candidate reference method [ 8 ], the %CDT by HPLC assay of Bio-Rad (Munich, Germany) with both standard [ 13 ] and fast procedures, and the ClinRep CDT [ 14 ] of Recipe (Munich, Germany). The immunonephelometric N Latex CDT assay [ 6 ] of Siemens (Marburg, Germany) was also included.…”

Section: Methodsmentioning

confidence: 99%

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Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: III. Performance of native serum and serum spiked with disialotransferrin proves that harmonization of CDT assays is possible

Weykamp

Wielders

Helander

et al. 2013

Clinical Chemistry and Laboratory Medicine

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Carbohydrate-deficient transferrin (CDT) is a generic term that refers to the transferrin glycoforms whose concentration in blood is temporarily increased by sustained alcohol consumption. Due to high clinical specificity, CDT was proposed as a biomarker of heavy alcohol use and has been available for about 20 years. A number of methods have been developed for CDT measurement based on different analytical techniques and principles and without any harmonization or calibration to a reference method. As a consequence, neither the reference limits nor the cut-off values have been similar across assays, hampering understanding of the diagnostic value of CDT and its routine use. This prompted the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) to initiate a Working Group on Standardization of CDT (WG-CDT). This third publication of the WG-CDT is devoted to testing the commutability of native and disialotransferrin-spiked serum panels as candidate secondary reference materials, in order to prove the harmonization potential of commercial CDT methods. The results showed that assay harmonization reduced the inter-laboratory imprecision in a network of reference laboratories running the HPLC candidate reference method. In the seven commercial methods evaluated in this study, the use of multi-level secondary calibrators of human serum origin significantly reduced the between-method imprecision. Thus, harmonization of CDT measurements by different methods can be achieved using this calibration system, opening the way for a full standardization of commercial methods against a reference method by use of certified reference materials.

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Section: Methodsmentioning

confidence: 99%

“…Some older methods also included part of trisialotransferrin. More recently, a direct immunoassay based on a monoclonal antibody that recognizes the transferrin glycoforms lacking at least one of the glycan chains was developed [ 6 ]. In the latter case, the measurand is probably a mixture of disialo-, monosialo-and asialotransferrin.…”

Section: Introductionmentioning

confidence: 99%

Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: III. Performance of native serum and serum spiked with disialotransferrin proves that harmonization of CDT assays is possible

Weykamp

Wielders

Helander

et al. 2013

Clinical Chemistry and Laboratory Medicine

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“…This is a large advantage for the new automatic CDT test in comparison to many other methods. The second large advantage of the direct CDT test is seen in its optimal diagnostic characteristics in adolescents and adults, as well as in males and females (23,24).…”

Section: Discussionmentioning

confidence: 99%

Carbohydrate-Deficient Transferrin - A Contemporary Biomarker in Comparison with Traditional Laboratory Markers of Chronic Alcohol Abuse

Maksić¹,

Vodnik²,

Stanković³

et al. 2010

Journal of Medical Biochemistry

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Summary: Timely identification of excessive alcohol use and its potential complications is a prerequisite for successful treatment. Several routine tests have been used in laboratories that may help in diagnosing alcoholism, such as determination of MCV, AST, ALT, GGT, but it has been shown that they lack specificity and sensitivity. Contemporary biomarkers are increasingly being used today that may due to their unique characteristics help in disco vering the onset of chronic alcohol abuse, as well as in abstinence and relapse monitoring. The term carbohydrate-deficient transferrin (CDT) stands for a small group of human transferrin isoforms (asialo, monosialo, and disialotran sferrin) with a lower degree of glycosylation in comparison to the dominant transferrin isoform (tetrasialotransferrin). Persons consuming large quantities of alcohol (≥50 -80 g daily) over a period of at least two weeks have increased concentrations of transferrin isoforms lacking one (disialo transferrin) or both (asialotransferrin) carbohydrate chains. In this paper the traditional markers of chronic alcohol abuse (GGT, AST, ALT, and MCV) were determined, as well as the new biomarker CDT, after which diagnostic evaluation was performed and their usability and clinical value in routine laboratory practice were estimated. These markers were also determined in heavy alcoholics on admission into hospital and after two weeks of therapy, with the aim of estimating their diagnostic value for abstinence and relapse monitoring. Keywords: alcoholism, biomarkers, CDT, transferrinKratak sadr`aj: Pravovremeno prepoznavanje preko merne upotrebe alkohola i potencijalnih komplika cija pred uslov je za uspe{no le~enje. U laboratorijama se koristi neko liko rutinskih testova koji mogu da pomognu u dijagnostici alkoholizma, kao npr. odre|ivanje MCV, AST, ALT, GGT, ali su se pokazali kao nedovoljno specifi~ni i osetljivi. Danas su sve vi{e u upotrebi savremeni biomarkeri koji zahvaljuju}i svojim jedin stvenim osobinama mogu da pomognu kod otkrivanja po ja ve hroni~nog alkoholizma, kao i pri pra}enju apstinencije i relapsa. Naziv transferin deficijentan ugljenim hidratima (CDT) podrazumeva manju grupu izoformi humanog trans ferina (asialo-, monosialo-i disialo-transferin), koje imaju ni`i stepen glikozilacije u pore|enju sa do minantnom izo for mom transferina (tetrasialotran sfe rin). Osobe koje unose velike koli~ine alkohola (≥50-80 g dnevno) u periodu od najmanje 2 nedelje imaju povi{ene koncentracije izoformi transferina kojima nedostaje jedan (disialotransferin) ili oba (asialotransferin) ugljeno hidratna lanca. U ovom radu oba vlje no je odre|ivanje tradicionalnih marke ra hroni~ne alko ho lne potro{nje (GGT, AST, ALT i MCV), kao i novog bio markera CDT, a zatim je izvr{ena dijagno sti~ka evaluacija i procena njihove upotrebljivosti i klini~ke vrednosti u rutin skoj laboratorijskoj praksi. Tako|e je izvr{eno odre|ivanje navedenih markera kod te{kih alkoholi~ara pri prijemu na bolni~ko odeljenje i nakon 2 nedelje terapije u cilju proce ne njihove dijag...

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“…The half-life of CDT is 1-1.5 weeks. Generally, it takes more than 2 weeks of abstinence for CDT levels to return to normal [1,4,7,8]. Measurement of CDT levels has not been routinely performed over the years because traditional methods for measuring CDT levels, such as isoelectric focusing, are laborious and time-consuming.…”

Section: Introductionmentioning

confidence: 99%

“…Several commercial immunoassay kits have been developed for the measurement of CDT levels, but the inclusion of trisialo-Tf in the CDT fraction can result in false high CDT values when these tests are used [2,9,10]. Recently, new methods, including capillary zone electrophoresis (EP) [11], high-performance liquid chromatography (HPLC) [3,10,12], and direct immunoassay using monoclonal antibodies [4] have been developed. These methods are automated and produce more reliable data.…”

Section: Introductionmentioning

confidence: 99%

Determination of Carbohydrate-deficient Transferrin Levels by Using Capillary Electrophoresis in a Korean Population

et al. 2010

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Carbohydrate-deficient transferrin (CDT) is reported to be an accurate biomarker for the detection of chronic alcohol abuse and for monitoring abstinence [1,2]. Transferrin (Tf) is the most important iron transport protein.Tf is synthesized primarily in the hepatocytes and consists of 3 substructural domains. These domains include a single polypeptide chain, 2 independent metal ionbinding sites, and 2 N-linked complex glycan chains [2].Tf exists in several glycoforms, which differ in the degree of branching of the N-linked glycan chains. The glycan chains have bi, tri, and tetraantennary structures [2,3].The primary Tf isoform is tetrasialo-Tf (64-80%). Other less abundant isoforms found in nonpathologic conditions include pentasialo-Tf, trisialo-Tf, and disialo-Tf Background: Carbohydrate-deficient transferrin (CDT) levels have rarely been determined in an Asian population. We evaluated the analytical performance of a test for measuring CDT levels by using capillary electrophoresis (EP).Methods: We determined the precision of CDT measurement by using capillary EP and nephelometry and compared the CDT values obtained using both the methods. We included healthy control subjects, abstinent patients with liver disease, and individuals consuming varying amounts of alcohol.Results: The CDT measurement by using capillary EP were correlated well with those CDT measurement by using nephelometry, N Latex CDT assay, Y=0.5706X+1.581, R=0.930. The results obtained from both methods showed good qualitative agreement with each other (k coefficient=0.61). Genetic variants of transferrin isoforms were detected in 4.1% of the tested population. Both the CDT and g -glutamyl transpeptidase (GGT) levels in the abstinent patients with liver disease were significantly higher than those in healthy abstinent individuals (0.9% vs. 0.5%, 109.5 mg/dL vs. 28.5 mg/dL, respectively), but the difference in CDT values in the 2 groups was less pronounced for the CDT values. Individuals who had a mean daily alcohol intake of more than 60 g/day showed significantly higher CDT levels than those who had a mean daily alcohol intake of less than 60 g/day (1.9% vs. 0.7%, P=0.03).Conclusions: The CDT test using capillary EP showed good performance, and this method has several advantages such as automation and detection of variant forms. Thus, CDT can be a more useful marker than GGT for monitoring alcohol abstinence, especially in patients with liver disease. (Korean J Lab Med 2010;30:477-84)

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

Cited by 76 publications

References 37 publications

Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: III. Performance of native serum and serum spiked with disialotransferrin proves that harmonization of CDT assays is possible

Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: III. Performance of native serum and serum spiked with disialotransferrin proves that harmonization of CDT assays is possible

Carbohydrate-Deficient Transferrin - A Contemporary Biomarker in Comparison with Traditional Laboratory Markers of Chronic Alcohol Abuse

Determination of Carbohydrate-deficient Transferrin Levels by Using Capillary Electrophoresis in a Korean Population

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