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 |
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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 |
doi_str_mv | 10.1373/clinchem.2006.084459 |
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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 <1.1 g/L. N Latex CDT results correlated with those of a commercial CDT immunoassay involving column separation (r(2) = 0.862) and an HPLC candidate reference method (r(2) = 0.978).
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.</description><identifier>ISSN: 0009-9147</identifier><identifier>EISSN: 1530-8561</identifier><identifier>DOI: 10.1373/clinchem.2006.084459</identifier><identifier>PMID: 17412797</identifier><identifier>CODEN: CLCHAU</identifier><language>eng</language><publisher>Washington, DC: Am Assoc Clin Chem</publisher><subject>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</subject><ispartof>Clinical chemistry (Baltimore, Md.), 2007-06, Vol.53 (6), p.1115-1121</ispartof><rights>2007 INIST-CNRS</rights><rights>Copyright American Association for Clinical Chemistry Jun 2007</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c574t-a86f76048cca5c443ddb2409728ae693f3479a02280dc2c5b22a072614c589663</citedby><cites>FETCH-LOGICAL-c574t-a86f76048cca5c443ddb2409728ae693f3479a02280dc2c5b22a072614c589663</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27903,27904</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18810986$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17412797$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:115484728$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Delanghe, Joris R</creatorcontrib><creatorcontrib>Helander, Anders</creatorcontrib><creatorcontrib>Wielders, Jos P.M</creatorcontrib><creatorcontrib>Pekelharing, J. Maurits</creatorcontrib><creatorcontrib>Roth, Heinz J</creatorcontrib><creatorcontrib>Schellenberg, Francois</creatorcontrib><creatorcontrib>Born, Catherine</creatorcontrib><creatorcontrib>Yagmur, Eray</creatorcontrib><creatorcontrib>Gentzer, Wolfgang</creatorcontrib><creatorcontrib>Althaus, Harald</creatorcontrib><title>Development and Multicenter Evaluation of the N Latex CDT Direct Immunonephelometric Assay for Serum Carbohydrate-Deficient Transferrin</title><title>Clinical chemistry (Baltimore, Md.)</title><addtitle>Clin Chem</addtitle><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 <1.1 g/L. N Latex CDT results correlated with those of a commercial CDT immunoassay involving column separation (r(2) = 0.862) and an HPLC candidate reference method (r(2) = 0.978).
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.</description><subject>Adolescent</subject><subject>Alcoholism</subject><subject>Alcoholism - diagnosis</subject><subject>Analytical, structural and metabolic biochemistry</subject><subject>Animals</subject><subject>Antibodies, Monoclonal - biosynthesis</subject><subject>Autoanalysis</subject><subject>Biological and medical sciences</subject><subject>Biomarkers - blood</subject><subject>Child</subject><subject>Congenital diseases</subject><subject>Congenital Disorders of Glycosylation - diagnosis</subject><subject>False Positive Reactions</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Genetic markers</subject><subject>Genetic variance</subject><subject>Genetic Variation</subject><subject>Glycosylation</subject><subject>Humans</subject><subject>Immunoassay</subject><subject>Immunoassays</subject><subject>Investigative techniques, diagnostic techniques (general aspects)</subject><subject>Latex</subject><subject>Liquid chromatography</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Methods</subject><subject>Mice</subject><subject>Mice, Inbred BALB C</subject><subject>Monoclonal antibodies</subject><subject>Nephelometry and Turbidimetry</subject><subject>Reference Values</subject><subject>Sensitivity and Specificity</subject><subject>Testing</subject><subject>Transferrin - analogs & derivatives</subject><subject>Transferrin - analysis</subject><subject>Transferrin - genetics</subject><subject>Transferrin - immunology</subject><issn>0009-9147</issn><issn>1530-8561</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNpdkt2O0zAQhSMEYsvCGyBkIcFdiu04_rlctQusVOCCcm05zoR4SeJiJxv6BLw2rhqoxJU9o--c0fg4y14SvCaFKN7Zzg22hX5NMeZrLBkr1aNsRcoC57Lk5HG2whirXBEmrrJnMd6nkgnJn2ZXRDBChRKr7PcWHqDzhx6GEZmhRp-mbnQ2VRDQ7YPpJjM6PyDfoLEF9BntzAi_0Ga7R1sXwI7oru-nwQ9waJNPD2NwFt3EaI6o8QF9hTD1aGNC5dtjHZI430LjrDvN2wczxAZCcMPz7EljuggvlvM6-_b-dr_5mO--fLjb3OxyWwo25kbyRnDMpLWmtIwVdV1RhpWg0gBXRVMwoQymVOLaUltWlBosKCfMllJxXlxn-dk3znCYKn0IrjfhqL1xemn9SDfQpcBClol_e-YPwf-cII66d9FC15kB_BQ1SaZEKZzA1_-B934KQ9pFU1IoRQomE8TOkA0-xgDNv_kE61Oq-m-q-pSqPqeaZK8W76nqob6IlhgT8GYBTLSma9K7WhcvnJQEK8kv27Tuezun_HTsTdclW6LneS4LzTUh6Qv9ATSsu0Y</recordid><startdate>20070601</startdate><enddate>20070601</enddate><creator>Delanghe, Joris R</creator><creator>Helander, Anders</creator><creator>Wielders, Jos P.M</creator><creator>Pekelharing, J. 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Maurits ; Roth, Heinz J ; Schellenberg, Francois ; Born, Catherine ; Yagmur, Eray ; Gentzer, Wolfgang ; Althaus, Harald</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c574t-a86f76048cca5c443ddb2409728ae693f3479a02280dc2c5b22a072614c589663</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Adolescent</topic><topic>Alcoholism</topic><topic>Alcoholism - diagnosis</topic><topic>Analytical, structural and metabolic biochemistry</topic><topic>Animals</topic><topic>Antibodies, Monoclonal - biosynthesis</topic><topic>Autoanalysis</topic><topic>Biological and medical sciences</topic><topic>Biomarkers - blood</topic><topic>Child</topic><topic>Congenital diseases</topic><topic>Congenital Disorders of Glycosylation - diagnosis</topic><topic>False Positive Reactions</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Genetic markers</topic><topic>Genetic variance</topic><topic>Genetic Variation</topic><topic>Glycosylation</topic><topic>Humans</topic><topic>Immunoassay</topic><topic>Immunoassays</topic><topic>Investigative techniques, diagnostic techniques (general aspects)</topic><topic>Latex</topic><topic>Liquid chromatography</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Methods</topic><topic>Mice</topic><topic>Mice, Inbred BALB C</topic><topic>Monoclonal antibodies</topic><topic>Nephelometry and Turbidimetry</topic><topic>Reference Values</topic><topic>Sensitivity and Specificity</topic><topic>Testing</topic><topic>Transferrin - analogs & derivatives</topic><topic>Transferrin - analysis</topic><topic>Transferrin - genetics</topic><topic>Transferrin - immunology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Delanghe, Joris R</creatorcontrib><creatorcontrib>Helander, Anders</creatorcontrib><creatorcontrib>Wielders, Jos P.M</creatorcontrib><creatorcontrib>Pekelharing, J. Maurits</creatorcontrib><creatorcontrib>Roth, Heinz J</creatorcontrib><creatorcontrib>Schellenberg, Francois</creatorcontrib><creatorcontrib>Born, Catherine</creatorcontrib><creatorcontrib>Yagmur, Eray</creatorcontrib><creatorcontrib>Gentzer, Wolfgang</creatorcontrib><creatorcontrib>Althaus, Harald</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>University Readers</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Nucleic Acids Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Materials Science & Engineering Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>Natural Science Collection</collection><collection>Earth, Atmospheric & Aquatic Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Materials Science Collection</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Materials Science Database</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Earth, Atmospheric & Aquatic Science Database</collection><collection>Materials Science Collection</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>Genetics Abstracts</collection><collection>SIRS Editorial</collection><collection>SwePub</collection><collection>SwePub Articles</collection><jtitle>Clinical chemistry (Baltimore, Md.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Delanghe, Joris R</au><au>Helander, Anders</au><au>Wielders, Jos P.M</au><au>Pekelharing, J. Maurits</au><au>Roth, Heinz J</au><au>Schellenberg, Francois</au><au>Born, Catherine</au><au>Yagmur, Eray</au><au>Gentzer, Wolfgang</au><au>Althaus, Harald</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Development and Multicenter Evaluation of the N Latex CDT Direct Immunonephelometric Assay for Serum Carbohydrate-Deficient Transferrin</atitle><jtitle>Clinical chemistry (Baltimore, Md.)</jtitle><addtitle>Clin Chem</addtitle><date>2007-06-01</date><risdate>2007</risdate><volume>53</volume><issue>6</issue><spage>1115</spage><epage>1121</epage><pages>1115-1121</pages><issn>0009-9147</issn><eissn>1530-8561</eissn><coden>CLCHAU</coden><abstract>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 <1.1 g/L. N Latex CDT results correlated with those of a commercial CDT immunoassay involving column separation (r(2) = 0.862) and an HPLC candidate reference method (r(2) = 0.978).
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.</abstract><cop>Washington, DC</cop><pub>Am Assoc Clin Chem</pub><pmid>17412797</pmid><doi>10.1373/clinchem.2006.084459</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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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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