Effect of antibody specificity on results of selected digoxin immunoassays among various clinical groups
We examined the specificity of three automated digoxin immunoassays (Abbott TDxFLx Digoxin II assay, Baxter-Dade Stratus II Digoxin assay, and Ciba Corning ACS Digoxin assay) applied without modification to (a) sera from 229 digoxin-free patients in 12 cohorts associated with nonspecific or endogeno...
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Veröffentlicht in: | Clinical chemistry (Baltimore, Md.) Md.), 1996-03, Vol.42 (3), p.373-379 |
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creator | Datta, P Xu, L Malik, S Landicho, D Ferreri, L Halverson, K Roby, PV Zebelman, AM Kenny, MA |
description | We examined the specificity of three automated digoxin immunoassays (Abbott TDxFLx Digoxin II assay, Baxter-Dade Stratus II Digoxin assay, and Ciba Corning ACS Digoxin assay) applied without modification to (a) sera from 229 digoxin-free patients in 12 cohorts associated with nonspecific or endogenous digoxin-like immunoreactive factor (DLIF) interference, and (b) drug-free serum supplemented with the major metabolites and analogs of digoxin. We observed three patterns of apparent digoxin results among the DLIF samples: one common to kidney and liver failure patients, where TDx and Stratus assays showed significant positive results; one common to newborns and cord blood, where only the TDx assay had significant interference; and one from cardiac surgery patients, where the Stratus assay alone showed interference. Of the three assays, the ACS had the least interference from DLIF. The assays also behaved differently with respect to cross-reactivity with digoxin metabolites, digitoxin, and digitoxin metabolites. The ACS assay again had the least analog or metabolite cross-reactivity. The three methods agreed well on digoxin-positive specimens, with a mean bias of 3 SD between the assay pairs compared) of only 3-5%. |
doi_str_mv | 10.1093/clinchem/42.3.373 |
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We observed three patterns of apparent digoxin results among the DLIF samples: one common to kidney and liver failure patients, where TDx and Stratus assays showed significant positive results; one common to newborns and cord blood, where only the TDx assay had significant interference; and one from cardiac surgery patients, where the Stratus assay alone showed interference. Of the three assays, the ACS had the least interference from DLIF. The assays also behaved differently with respect to cross-reactivity with digoxin metabolites, digitoxin, and digitoxin metabolites. The ACS assay again had the least analog or metabolite cross-reactivity. The three methods agreed well on digoxin-positive specimens, with a mean bias of <0.15 microgram/L digoxin for each and discrepancies (defined as >3 SD between the assay pairs compared) of only 3-5%.</description><identifier>ISSN: 0009-9147</identifier><identifier>EISSN: 1530-8561</identifier><identifier>DOI: 10.1093/clinchem/42.3.373</identifier><identifier>PMID: 8598098</identifier><identifier>CODEN: CLCHAU</identifier><language>eng</language><publisher>Washington, DC: Am Assoc Clin Chem</publisher><subject>Antibody Specificity ; Autoanalysis ; Biological and medical sciences ; Blood Proteins - analysis ; Cardenolides ; Cardiotonic agents ; Cardiovascular system ; Cohort Studies ; Digoxin - blood ; Digoxin - immunology ; Fetal Blood - chemistry ; Humans ; Immunoassay ; Infant, Newborn ; Liver Failure - blood ; Medical sciences ; Pharmacology. Drug treatments ; Reagent Kits, Diagnostic ; Renal Insufficiency - blood ; Saponins ; Sensitivity and Specificity</subject><ispartof>Clinical chemistry (Baltimore, Md.), 1996-03, Vol.42 (3), p.373-379</ispartof><rights>1996 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c398t-e9a11514f978e513ff5b26bf3935724c001966419837e433c28ca59990082e413</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=3026086$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/8598098$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Datta, P</creatorcontrib><creatorcontrib>Xu, L</creatorcontrib><creatorcontrib>Malik, S</creatorcontrib><creatorcontrib>Landicho, D</creatorcontrib><creatorcontrib>Ferreri, L</creatorcontrib><creatorcontrib>Halverson, K</creatorcontrib><creatorcontrib>Roby, PV</creatorcontrib><creatorcontrib>Zebelman, AM</creatorcontrib><creatorcontrib>Kenny, MA</creatorcontrib><title>Effect of antibody specificity on results of selected digoxin immunoassays among various clinical groups</title><title>Clinical chemistry (Baltimore, Md.)</title><addtitle>Clin Chem</addtitle><description>We examined the specificity of three automated digoxin immunoassays (Abbott TDxFLx Digoxin II assay, Baxter-Dade Stratus II Digoxin assay, and Ciba Corning ACS Digoxin assay) applied without modification to (a) sera from 229 digoxin-free patients in 12 cohorts associated with nonspecific or endogenous digoxin-like immunoreactive factor (DLIF) interference, and (b) drug-free serum supplemented with the major metabolites and analogs of digoxin. We observed three patterns of apparent digoxin results among the DLIF samples: one common to kidney and liver failure patients, where TDx and Stratus assays showed significant positive results; one common to newborns and cord blood, where only the TDx assay had significant interference; and one from cardiac surgery patients, where the Stratus assay alone showed interference. Of the three assays, the ACS had the least interference from DLIF. The assays also behaved differently with respect to cross-reactivity with digoxin metabolites, digitoxin, and digitoxin metabolites. The ACS assay again had the least analog or metabolite cross-reactivity. The three methods agreed well on digoxin-positive specimens, with a mean bias of <0.15 microgram/L digoxin for each and discrepancies (defined as >3 SD between the assay pairs compared) of only 3-5%.</description><subject>Antibody Specificity</subject><subject>Autoanalysis</subject><subject>Biological and medical sciences</subject><subject>Blood Proteins - analysis</subject><subject>Cardenolides</subject><subject>Cardiotonic agents</subject><subject>Cardiovascular system</subject><subject>Cohort Studies</subject><subject>Digoxin - blood</subject><subject>Digoxin - immunology</subject><subject>Fetal Blood - chemistry</subject><subject>Humans</subject><subject>Immunoassay</subject><subject>Infant, Newborn</subject><subject>Liver Failure - blood</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><subject>Reagent Kits, Diagnostic</subject><subject>Renal Insufficiency - blood</subject><subject>Saponins</subject><subject>Sensitivity and Specificity</subject><issn>0009-9147</issn><issn>1530-8561</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1996</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kEFv2zAMhYVhRZem_QE7DNBh682pZMm2dByKbi1QoJftLCgKlWiQrVS0m-bfT1mynAiCHx8fHyGfOVtwpsWdi2FwG-jvZL0QC9GJD2TGG8Eq1bT8I5kxxnSluew-kSvEP6WVnWovyaVqtGJazcjmwXtwI02e2mEMy7TaU9yCCz64MO5pGmgGnOKIBwQhFhhWdBXW6T0MNPT9NCSLaPdIbZ-GNX2zOaQJ6cFbcDbSdU7TFq_JhbcR4eZU5-T3j4df94_V88vPp_vvz5UTWo0VaMt5w6XXnYKGC--bZd0uvdCi6WrpGOO6bSXXSnQghXC1crbRWjOmapBczMntUXeb0-sEOJo-oIMY7QDFluk63TLVigLyI-hyQszgzTaH3ua94cwc0jX_0zWyNsKUdMvOl5P4tOxhdd44xVnmX09zi-V1n-3gAp4xwep_t-fk2xHbhPVmFzIY7G2MRZSb3W53PvcXHtuSSg</recordid><startdate>19960301</startdate><enddate>19960301</enddate><creator>Datta, P</creator><creator>Xu, L</creator><creator>Malik, S</creator><creator>Landicho, D</creator><creator>Ferreri, L</creator><creator>Halverson, K</creator><creator>Roby, PV</creator><creator>Zebelman, AM</creator><creator>Kenny, MA</creator><general>Am Assoc Clin Chem</general><general>American Association for Clinical Chemistry</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>19960301</creationdate><title>Effect of antibody specificity on results of selected digoxin immunoassays among various clinical groups</title><author>Datta, P ; Xu, L ; Malik, S ; Landicho, D ; Ferreri, L ; Halverson, K ; Roby, PV ; Zebelman, AM ; Kenny, MA</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c398t-e9a11514f978e513ff5b26bf3935724c001966419837e433c28ca59990082e413</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1996</creationdate><topic>Antibody Specificity</topic><topic>Autoanalysis</topic><topic>Biological and medical sciences</topic><topic>Blood Proteins - analysis</topic><topic>Cardenolides</topic><topic>Cardiotonic agents</topic><topic>Cardiovascular system</topic><topic>Cohort Studies</topic><topic>Digoxin - blood</topic><topic>Digoxin - immunology</topic><topic>Fetal Blood - chemistry</topic><topic>Humans</topic><topic>Immunoassay</topic><topic>Infant, Newborn</topic><topic>Liver Failure - blood</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><topic>Reagent Kits, Diagnostic</topic><topic>Renal Insufficiency - blood</topic><topic>Saponins</topic><topic>Sensitivity and Specificity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Datta, P</creatorcontrib><creatorcontrib>Xu, L</creatorcontrib><creatorcontrib>Malik, S</creatorcontrib><creatorcontrib>Landicho, D</creatorcontrib><creatorcontrib>Ferreri, L</creatorcontrib><creatorcontrib>Halverson, K</creatorcontrib><creatorcontrib>Roby, PV</creatorcontrib><creatorcontrib>Zebelman, AM</creatorcontrib><creatorcontrib>Kenny, MA</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>MEDLINE - Academic</collection><jtitle>Clinical chemistry (Baltimore, Md.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Datta, P</au><au>Xu, L</au><au>Malik, S</au><au>Landicho, D</au><au>Ferreri, L</au><au>Halverson, K</au><au>Roby, PV</au><au>Zebelman, AM</au><au>Kenny, MA</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of antibody specificity on results of selected digoxin immunoassays among various clinical groups</atitle><jtitle>Clinical chemistry (Baltimore, Md.)</jtitle><addtitle>Clin Chem</addtitle><date>1996-03-01</date><risdate>1996</risdate><volume>42</volume><issue>3</issue><spage>373</spage><epage>379</epage><pages>373-379</pages><issn>0009-9147</issn><eissn>1530-8561</eissn><coden>CLCHAU</coden><abstract>We examined the specificity of three automated digoxin immunoassays (Abbott TDxFLx Digoxin II assay, Baxter-Dade Stratus II Digoxin assay, and Ciba Corning ACS Digoxin assay) applied without modification to (a) sera from 229 digoxin-free patients in 12 cohorts associated with nonspecific or endogenous digoxin-like immunoreactive factor (DLIF) interference, and (b) drug-free serum supplemented with the major metabolites and analogs of digoxin. We observed three patterns of apparent digoxin results among the DLIF samples: one common to kidney and liver failure patients, where TDx and Stratus assays showed significant positive results; one common to newborns and cord blood, where only the TDx assay had significant interference; and one from cardiac surgery patients, where the Stratus assay alone showed interference. Of the three assays, the ACS had the least interference from DLIF. The assays also behaved differently with respect to cross-reactivity with digoxin metabolites, digitoxin, and digitoxin metabolites. The ACS assay again had the least analog or metabolite cross-reactivity. The three methods agreed well on digoxin-positive specimens, with a mean bias of <0.15 microgram/L digoxin for each and discrepancies (defined as >3 SD between the assay pairs compared) of only 3-5%.</abstract><cop>Washington, DC</cop><pub>Am Assoc Clin Chem</pub><pmid>8598098</pmid><doi>10.1093/clinchem/42.3.373</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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source | MEDLINE; Oxford University Press Journals All Titles (1996-Current) |
subjects | Antibody Specificity Autoanalysis Biological and medical sciences Blood Proteins - analysis Cardenolides Cardiotonic agents Cardiovascular system Cohort Studies Digoxin - blood Digoxin - immunology Fetal Blood - chemistry Humans Immunoassay Infant, Newborn Liver Failure - blood Medical sciences Pharmacology. Drug treatments Reagent Kits, Diagnostic Renal Insufficiency - blood Saponins Sensitivity and Specificity |
title | Effect of antibody specificity on results of selected digoxin immunoassays among various clinical groups |
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