{"id":"https://openalex.org/W2132395844","doi":"https://doi.org/10.1373/clinchem.2013.220772","title":"Utilization of Assay Performance Characteristics to Estimate Hemoglobin A1c Result Reliability","display_name":"Utilization of Assay Performance Characteristics to Estimate Hemoglobin A1c Result Reliability","publication_year":2014,"publication_date":"2014-05-10","ids":{"openalex":"https://openalex.org/W2132395844","doi":"https://doi.org/10.1373/clinchem.2013.220772","mag":"2132395844","pmid":"https://pubmed.ncbi.nlm.nih.gov/24815907"},"language":"en","primary_location":{"id":"doi:10.1373/clinchem.2013.220772","doi":"https://doi.org/10.1373/clinchem.2013.220772","is_oa":false,"landing_page_url":"https://doi.org/10.1373/clinchem.2013.220772","pdf_url":null,"source":{"id":"https://openalex.org/S139212996","display_name":"Clinical Chemistry","issn_l":"0009-9147","issn":["0009-9147","1530-8561"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320272","host_organization_name":"American Association for Clinical Chemistry","host_organization_lineage":["https://openalex.org/P4310320272"],"host_organization_lineage_names":["American Association for Clinical Chemistry"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Chemistry","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","datacite","pubmed"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://cdr.lib.unc.edu/downloads/d217qz46n","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5023300786","display_name":"Alison L. Woodworth","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I200719446","display_name":"Vanderbilt University","ror":"https://ror.org/02vm5rt34","country_code":"US","type":"education","lineage":["https://openalex.org/I200719446"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Alison Woodworth","raw_affiliation_strings":["Vanderbilt University, Nashville, TN"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Vanderbilt University, Nashville, TN","institution_ids":["https://openalex.org/I200719446"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5056528239","display_name":"Nichole L Korpi-Steiner","orcid":"https://orcid.org/0009-0007-7924-599X","observed_orcids":["https://orcid.org/0009-0007-7924-599X"]},"institutions":[{"id":"https://openalex.org/I114027177","display_name":"University of North Carolina at Chapel Hill","ror":"https://ror.org/0130frc33","country_code":"US","type":"education","lineage":["https://openalex.org/I114027177"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Nichole Korpi-Steiner","raw_affiliation_strings":["University of North Carolina, Chapel Hill, NC","University of North Carolina, Chapel, Hill, NC#TAB#"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of North Carolina, Chapel Hill, NC","institution_ids":["https://openalex.org/I114027177"]},{"raw_affiliation_string":"University of North Carolina, Chapel, Hill, NC#TAB#","institution_ids":["https://openalex.org/I114027177"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5113641605","display_name":"James J. Miller","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I142740786","display_name":"University of Louisville","ror":"https://ror.org/01ckdn478","country_code":"US","type":"education","lineage":["https://openalex.org/I142740786"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"James J Miller","raw_affiliation_strings":["University of Louisville, Louisville, KY"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Louisville, Louisville, KY","institution_ids":["https://openalex.org/I142740786"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5085034309","display_name":"Lokinendi V. Rao","orcid":"https://orcid.org/0000-0001-6019-479X","observed_orcids":["https://orcid.org/0000-0001-6019-479X"]},"institutions":[{"id":"https://openalex.org/I4210162397","display_name":"UMass Memorial Medical Center","ror":"https://ror.org/053v00853","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1303243448","https://openalex.org/I166722992","https://openalex.org/I4210162397"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Lokinendi V Rao","raw_affiliation_strings":["UMass Memorial Medical Center, Worcester, MA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"UMass Memorial Medical Center, Worcester, MA","institution_ids":["https://openalex.org/I4210162397"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5010912140","display_name":"John C. Yundt-Pacheco","orcid":"https://orcid.org/0000-0001-8713-1051","observed_orcids":["https://orcid.org/0000-0001-8713-1051"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"John Yundt-Pacheco","raw_affiliation_strings":["Bio-Rad Quality System Division, Plano, TX"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Bio-Rad Quality System Division, Plano, TX","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5043877831","display_name":"Lakshmi Kuchipudi","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Lakshmi Kuchipudi","raw_affiliation_strings":["Bio-Rad Quality System Division, Plano, TX"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Bio-Rad Quality System Division, Plano, TX","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5045007833","display_name":"Curtis A. Parvin","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Curtis A Parvin","raw_affiliation_strings":["Bio-Rad Quality System Division, Plano, TX"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Bio-Rad Quality System Division, Plano, TX","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5047973982","display_name":"Jeanne M. Rhea","orcid":"https://orcid.org/0000-0001-8107-6872","observed_orcids":["https://orcid.org/0000-0001-8107-6872"]},"institutions":[{"id":"https://openalex.org/I150468666","display_name":"Emory University","ror":"https://ror.org/03czfpz43","country_code":"US","type":"education","lineage":["https://openalex.org/I150468666"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Jeanne M Rhea","raw_affiliation_strings":["Emory University School of Medicine, Atlanta, GA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Emory University School of Medicine, Atlanta, GA","institution_ids":["https://openalex.org/I150468666"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5068882390","display_name":"Ross J. Molinaro","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I150468666","display_name":"Emory University","ror":"https://ror.org/03czfpz43","country_code":"US","type":"education","lineage":["https://openalex.org/I150468666"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Ross Molinaro","raw_affiliation_strings":["Emory University School of Medicine, Atlanta, GA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Emory University School of Medicine, Atlanta, GA","institution_ids":["https://openalex.org/I150468666"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":5,"corresponding_author_ids":["https://openalex.org/A5068882390"],"corresponding_institution_ids":["https://openalex.org/I150468666"],"apc_list":{"value":4636,"currency":"USD","value_usd":4636},"apc_paid":null,"fwci":4.2102,"has_fulltext":true,"cited_by_count":35,"citation_normalized_percentile":{"value":0.94418636,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":89,"max":99},"biblio":{"volume":"60","issue":"8","first_page":"1073","last_page":"1079"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11314","display_name":"Clinical Laboratory Practices and Quality Control","score":0.9984999895095825,"subfield":{"id":"https://openalex.org/subfields/2737","display_name":"Physiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T11314","display_name":"Clinical Laboratory Practices and Quality Control","score":0.9984999895095825,"subfield":{"id":"https://openalex.org/subfields/2737","display_name":"Physiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11890","display_name":"Scientific Measurement and Uncertainty Evaluation","score":0.00019999999494757503,"subfield":{"id":"https://openalex.org/subfields/1804","display_name":"Statistics, Probability and Uncertainty"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T10560","display_name":"Diabetes Management and Research","score":0.00019999999494757503,"subfield":{"id":"https://openalex.org/subfields/2712","display_name":"Endocrinology, Diabetes and Metabolism"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/hba1c","display_name":"HbA1c","score":0.9900000095367432},{"id":"https://openalex.org/keywords/total-allowable-error","display_name":"total allowable error","score":0.9020000100135803},{"id":"https://openalex.org/keywords/assay-imprecision","display_name":"assay imprecision","score":0.8299999833106995},{"id":"https://openalex.org/keywords/assay-bias","display_name":"assay bias","score":0.902999997138977},{"id":"https://openalex.org/keywords/quality-control","display_name":"quality control","score":0.7429999709129333},{"id":"https://openalex.org/keywords/diabetes-monitoring","display_name":"diabetes monitoring","score":0.453000009059906}],"concepts":[{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.5335014462471008},{"id":"https://openalex.org/C43214815","wikidata":"https://www.wikidata.org/wiki/Q7310987","display_name":"Reliability (semiconductor)","level":3,"score":0.5005781650543213},{"id":"https://openalex.org/C46304622","wikidata":"https://www.wikidata.org/wiki/Q374814","display_name":"Certification","level":2,"score":0.44832319021224976},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.4374341368675232},{"id":"https://openalex.org/C155512373","wikidata":"https://www.wikidata.org/wiki/Q287450","display_name":"Residual","level":2,"score":0.4110684096813202},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.3776330351829529},{"id":"https://openalex.org/C200601418","wikidata":"https://www.wikidata.org/wiki/Q2193887","display_name":"Reliability engineering","level":1,"score":0.3372625708580017},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.13909292221069336},{"id":"https://openalex.org/C11413529","wikidata":"https://www.wikidata.org/wiki/Q8366","display_name":"Algorithm","level":1,"score":0.13579267263412476},{"id":"https://openalex.org/C121332964","wikidata":"https://www.wikidata.org/wiki/Q413","display_name":"Physics","level":0,"score":0.11204361915588379},{"id":"https://openalex.org/C162324750","wikidata":"https://www.wikidata.org/wiki/Q8134","display_name":"Economics","level":0,"score":0.08128497004508972},{"id":"https://openalex.org/C187736073","wikidata":"https://www.wikidata.org/wiki/Q2920921","display_name":"Management","level":1,"score":0.0},{"id":"https://openalex.org/C62520636","wikidata":"https://www.wikidata.org/wiki/Q944","display_name":"Quantum mechanics","level":1,"score":0.0},{"id":"https://openalex.org/C163258240","wikidata":"https://www.wikidata.org/wiki/Q25342","display_name":"Power (physics)","level":2,"score":0.0}],"mesh":[{"descriptor_ui":"D006442","descriptor_name":"Glycated Hemoglobin","qualifier_ui":"Q000032","qualifier_name":"analysis","is_major_topic":true},{"descriptor_ui":"D006442","descriptor_name":"Glycated Hemoglobin","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D015203","descriptor_name":"Reproducibility of Results","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":4,"locations":[{"id":"doi:10.1373/clinchem.2013.220772","doi":"https://doi.org/10.1373/clinchem.2013.220772","is_oa":false,"landing_page_url":"https://doi.org/10.1373/clinchem.2013.220772","pdf_url":null,"source":{"id":"https://openalex.org/S139212996","display_name":"Clinical Chemistry","issn_l":"0009-9147","issn":["0009-9147","1530-8561"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320272","host_organization_name":"American Association for Clinical Chemistry","host_organization_lineage":["https://openalex.org/P4310320272"],"host_organization_lineage_names":["American Association for Clinical Chemistry"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Chemistry","raw_type":"journal-article"},{"id":"pmid:24815907","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/24815907","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical chemistry","raw_type":"Journal Article"},{"id":"pmh:cdr.lib.unc.edu:0p096g910","doi":null,"is_oa":true,"landing_page_url":"https://doi.org/10.17615/wb7b-mr67","pdf_url":"https://cdr.lib.unc.edu/downloads/d217qz46n","source":{"id":"https://openalex.org/S4306401075","display_name":"Carolina Digital Repository (University of North Carolina at Chapel Hill)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I114027177","host_organization_name":"University of North Carolina at Chapel Hill","host_organization_lineage":["https://openalex.org/I114027177"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Clinical Chemistry, 60(8)","raw_type":"Article"},{"id":"doi:10.17615/wb7b-mr67","doi":"https://doi.org/10.17615/wb7b-mr67","is_oa":true,"landing_page_url":"https://doi.org/10.17615/wb7b-mr67","pdf_url":null,"source":{"id":"https://openalex.org/S7407051488","display_name":"UNC Libraries","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"article-journal"}],"best_oa_location":{"id":"pmh:cdr.lib.unc.edu:0p096g910","doi":null,"is_oa":true,"landing_page_url":"https://doi.org/10.17615/wb7b-mr67","pdf_url":"https://cdr.lib.unc.edu/downloads/d217qz46n","source":{"id":"https://openalex.org/S4306401075","display_name":"Carolina Digital Repository (University of North Carolina at Chapel Hill)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I114027177","host_organization_name":"University of North Carolina at Chapel Hill","host_organization_lineage":["https://openalex.org/I114027177"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Clinical Chemistry, 60(8)","raw_type":"Article"},"sustainable_development_goals":[{"score":0.9391000270843506,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W2132395844.pdf","grobid_xml":"https://content.openalex.org/works/W2132395844.grobid-xml"},"referenced_works_count":10,"referenced_works":["https://openalex.org/W2016622896","https://openalex.org/W2022781789","https://openalex.org/W2088264345","https://openalex.org/W2102127536","https://openalex.org/W2135517124","https://openalex.org/W2144300409","https://openalex.org/W2168508018","https://openalex.org/W2415747451","https://openalex.org/W2470120273","https://openalex.org/W2510708214"],"related_works":["https://openalex.org/W2008721727","https://openalex.org/W2144300409","https://openalex.org/W7203870558","https://openalex.org/W2104992851","https://openalex.org/W3029523777","https://openalex.org/W2323477666","https://openalex.org/W2163595957","https://openalex.org/W2356677416","https://openalex.org/W2896249616","https://openalex.org/W2384321182"],"abstract_inverted_index":{"BACKGROUND:":[0],"Allowable":[1],"total":[2],"error":[3],"(TE(a))":[4],"goals":[5],"for":[6,113,145,160,220],"hemoglobin":[7],"(Hb)":[8],"A(1c)":[9,51,70,109,182,224,240],"require":[10],"minimal":[11],"assay":[12,45,115],"imprecision":[13,72,144],"and":[14,16,44,63,73,80,95,102,122,233],"bias":[15,74,150],"implementation":[17],"of":[18,33,37,48,105,119,128,135,154,178,236],"a":[19,40,138,197],"robust":[20],"QC":[21,42,215,231],"monitoring":[22],"program.":[23],"Here,":[24],"we":[25],"compare":[26],"the":[27,31,76,103,152,155,176,188,205,212],"combined":[28],"influence":[29],"on":[30,75,168],"risk":[32,104,235],"reporting":[34,106,161,179],"unreliable":[35,107,162,180,238],"results":[36,110,163,183],"TE(a)":[38,117,140],"goals,":[39],"routine":[41],"practice,":[43],"performance":[46,170],"characteristics":[47],"6":[49],"Hb":[50,69,108,181,223,239],"instruments":[52,147],"across":[53],"4":[54],"academic":[55],"medical":[56],"centers.":[57],"METHODS:":[58],"The":[59],"CLSI":[60],"protocols":[61],"EP-5":[62],"EP-9":[64],"were":[65,111,194],"applied":[66],"to":[67,229],"investigate":[68],"result":[71],"Variant":[77,81],"II":[78,82],"Turbo":[79],"(Bio-Rad),":[83],"G8":[84],"(Tosoh),":[85],"Capillarys":[86,206],"2":[87,207],"Flex":[88,208],"Piercing":[89,209],"(Sebia),":[90],"COBAS":[91],"Integra":[92],"800":[93],"(Roche),":[94],"DCA":[96],"Vantage":[97],"(Siemens).":[98],"Patient-weighted":[99],"\u03c3":[100,130,156],"values":[101,131],"determined":[112],"each":[114],"at":[116,137],"specifications":[118],"5%,":[120],"6%,":[121],"7%.":[123],"RESULTS:":[124],"A":[125],"large":[126],"range":[127],"patient-weighted":[129],"spanning":[132],"0.5":[133],"orders":[134],"magnitude":[136],"6%":[139,198],"was":[141,148],"observed.":[142,158,195],"Although":[143],"all":[146,203],"<3%,":[149],"impacted":[151],"majority":[153],"changes":[157],"Estimates":[159],"varied":[164],"almost":[165],"500-fold":[166],"based":[167],"analytical":[169],"alone.":[171],"CONCLUSIONS:":[172],"Considerable":[173],"differences":[174],"in":[175],"probability":[177],"between":[184],"different":[185],"NGSP":[186],"(formerly":[187],"National":[189],"Glycohemoglobin":[190],"Standardization":[191],"Program)-certified":[192],"platforms":[193],"At":[196],"TE(a),":[199],"our":[200],"study":[201],"indicates":[202],"but":[204],"requires":[210],"that":[211],"maximum":[213],"affordable":[214],"be":[216,227],"run.":[217],"Risk":[218],"estimates":[219],"individual":[221],"laboratories'":[222],"methods":[225],"can":[226],"used":[228],"assess":[230],"practices":[232],"residual":[234],"an":[237],"result.":[241]},"counts_by_year":[{"year":2026,"cited_by_count":2},{"year":2024,"cited_by_count":1},{"year":2021,"cited_by_count":3},{"year":2020,"cited_by_count":2},{"year":2019,"cited_by_count":3},{"year":2018,"cited_by_count":5},{"year":2017,"cited_by_count":7},{"year":2016,"cited_by_count":4},{"year":2015,"cited_by_count":6},{"year":2014,"cited_by_count":2}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2016-06-24T00:00:00"}