Reassessment of the Access Testosterone chemiluminescence assay and comparison with LC‐MS method
Aim of the study To reassess the imprecision and Limit of Quantitation, to evaluate the cross‐reaction with dehydroepiandrosterone‐sulfate (DHEAS), the accuracy toward liquid chromatography‐mass spectrometry (LC‐MS) and the reference interval of the Access Testosterone method, performed by DxI immun...
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| Veröffentlicht in: | Journal of clinical laboratory analysis 2018-03, Vol.32 (3), p.n/a |
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| creator | Dittadi, Ruggero Matteucci, Mara Meneghetti, Elisa Ndreu, Rudina |
| description | Aim of the study
To reassess the imprecision and Limit of Quantitation, to evaluate the cross‐reaction with dehydroepiandrosterone‐sulfate (DHEAS), the accuracy toward liquid chromatography‐mass spectrometry (LC‐MS) and the reference interval of the Access Testosterone method, performed by DxI immunoassay platform (Beckman Coulter).
Material and Methods
Imprecision was evaluated testing six pool samples assayed in 20 different run using two reagents lots. The cross‐reaction with DHEAS was studied both by a displacement curve and by spiking DHEAS standard in two serum samples with known amount of testosterone. The comparison with LC‐MS was evaluated by Passing‐Bablock analysis in 21 routine serum samples and 19 control samples from an External Quality Assurance (EQA) scheme. The reference interval was verified by an indirect estimation on 2445 male and 2838 female outpatients.
Results
The imprecision study showed a coefficient of variation (CV) between 2.7% and 34.7% for serum pools from 16.3 and 0.27 nmol/L. The value of Limit of Quantitation at 20% CV was 0.53 nmol/L. The DHEAS showed a cross‐reaction of 0.0074%. A comparison with LC‐MS showed a trend toward a slight underestimation of immunoassay vs LC‐MS (Passing‐Bablock equations: DxI=−0.24+0.906 LCMS in serum samples and DxI=−0.299+0.981 LCMS in EQA samples). The verification of reference interval showed a 2.5th‐97.5th percentile distribution of 6.6‐24.3 nmol/L for male over 14 years and |
| doi_str_mv | 10.1002/jcla.22286 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6817188</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2013755122</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4486-1b618ce046bd42275ed2d53dd3fefa9a4a041dabb9a0429b3f2f6fb06cd8d0f43</originalsourceid><addsrcrecordid>eNp9kd9uFCEYxUmjadfamz6AIfHGmEwLDDPD3JhsNv7NmiZarwkDHw6bGdjCjM3e-Qg-o08i69ameuEVBH6c7xwOQueUXFBC2OVGD-qCMSbqI7SgpBUFE6x6hBZEiKYQhJYn6ElKG0KIaGl9jE4yyktOqgXqPoFKCVIawU84WDz1gJda5xN8DWkKaYIYPGDdw-iGeXQekgavAed3aoeVN1iHcauiS8HjWzf1eL36-f3Hx894hKkP5il6bNWQ4OxuPUVf3ry-Xr0r1ldv36-W60JzLuqCdjUVGgivO8MZayowzFSlMaUFq1rFFeHUqK5r84a1XWmZrW1Ham2EIZaXp-jVQXc7dyOYbHKKapDb6EYVdzIoJ_--8a6XX8M3WQvaUCGywIs7gRhu5hxeji5nHQblIcxJ0paWZds2ZD_r-T_oJszR53iS5f9uqooylqmXB0rHkFIEe2-GErmvTu6rk7-ry_Czh_bv0T9dZYAegFs3wO4_UvLDar08iP4COXOnHQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2013755122</pqid></control><display><type>article</type><title>Reassessment of the Access Testosterone chemiluminescence assay and comparison with LC‐MS method</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central</source><creator>Dittadi, Ruggero ; Matteucci, Mara ; Meneghetti, Elisa ; Ndreu, Rudina</creator><creatorcontrib>Dittadi, Ruggero ; Matteucci, Mara ; Meneghetti, Elisa ; Ndreu, Rudina</creatorcontrib><description>Aim of the study
To reassess the imprecision and Limit of Quantitation, to evaluate the cross‐reaction with dehydroepiandrosterone‐sulfate (DHEAS), the accuracy toward liquid chromatography‐mass spectrometry (LC‐MS) and the reference interval of the Access Testosterone method, performed by DxI immunoassay platform (Beckman Coulter).
Material and Methods
Imprecision was evaluated testing six pool samples assayed in 20 different run using two reagents lots. The cross‐reaction with DHEAS was studied both by a displacement curve and by spiking DHEAS standard in two serum samples with known amount of testosterone. The comparison with LC‐MS was evaluated by Passing‐Bablock analysis in 21 routine serum samples and 19 control samples from an External Quality Assurance (EQA) scheme. The reference interval was verified by an indirect estimation on 2445 male and 2838 female outpatients.
Results
The imprecision study showed a coefficient of variation (CV) between 2.7% and 34.7% for serum pools from 16.3 and 0.27 nmol/L. The value of Limit of Quantitation at 20% CV was 0.53 nmol/L. The DHEAS showed a cross‐reaction of 0.0074%. A comparison with LC‐MS showed a trend toward a slight underestimation of immunoassay vs LC‐MS (Passing‐Bablock equations: DxI=−0.24+0.906 LCMS in serum samples and DxI=−0.299+0.981 LCMS in EQA samples). The verification of reference interval showed a 2.5th‐97.5th percentile distribution of 6.6‐24.3 nmol/L for male over 14 years and <0.5‐2.78 nmol/L for female subjects, in accord with the reference intervals reported by the manufacturer.
Conclusions
The Access Testosterone method could be considered an adequately reliable tool for the testosterone measurement.</description><identifier>ISSN: 0887-8013</identifier><identifier>EISSN: 1098-2825</identifier><identifier>DOI: 10.1002/jcla.22286</identifier><identifier>PMID: 28643405</identifier><language>eng</language><publisher>United States: John Wiley & Sons, Inc</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Chemiluminescence ; Chromatography, Liquid - methods ; Chromatography, Liquid - standards ; cross‐reaction ; Dehydroepiandrosterone ; DxI platform ; Humans ; Immunoassay ; Immunoassay - methods ; Immunoassay - standards ; immunoassay method ; Liquid chromatography ; liquid chromatography‐mass spectrometry ; LoQ ; Male ; Mass Spectrometry - methods ; Mass Spectrometry - standards ; Mass spectroscopy ; Mathematical models ; Middle Aged ; Quality assurance ; Quantitation ; Reference Values ; Reproducibility of Results ; Sensitivity and Specificity ; Sulfate ; Testosterone ; Testosterone - blood ; Young Adult</subject><ispartof>Journal of clinical laboratory analysis, 2018-03, Vol.32 (3), p.n/a</ispartof><rights>2017 Wiley Periodicals, Inc.</rights><rights>Copyright © 2018 Wiley Periodicals, Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4486-1b618ce046bd42275ed2d53dd3fefa9a4a041dabb9a0429b3f2f6fb06cd8d0f43</citedby><cites>FETCH-LOGICAL-c4486-1b618ce046bd42275ed2d53dd3fefa9a4a041dabb9a0429b3f2f6fb06cd8d0f43</cites><orcidid>0000-0003-2274-9648</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6817188/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6817188/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,723,776,780,881,1411,27901,27902,45550,45551,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28643405$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dittadi, Ruggero</creatorcontrib><creatorcontrib>Matteucci, Mara</creatorcontrib><creatorcontrib>Meneghetti, Elisa</creatorcontrib><creatorcontrib>Ndreu, Rudina</creatorcontrib><title>Reassessment of the Access Testosterone chemiluminescence assay and comparison with LC‐MS method</title><title>Journal of clinical laboratory analysis</title><addtitle>J Clin Lab Anal</addtitle><description>Aim of the study
To reassess the imprecision and Limit of Quantitation, to evaluate the cross‐reaction with dehydroepiandrosterone‐sulfate (DHEAS), the accuracy toward liquid chromatography‐mass spectrometry (LC‐MS) and the reference interval of the Access Testosterone method, performed by DxI immunoassay platform (Beckman Coulter).
Material and Methods
Imprecision was evaluated testing six pool samples assayed in 20 different run using two reagents lots. The cross‐reaction with DHEAS was studied both by a displacement curve and by spiking DHEAS standard in two serum samples with known amount of testosterone. The comparison with LC‐MS was evaluated by Passing‐Bablock analysis in 21 routine serum samples and 19 control samples from an External Quality Assurance (EQA) scheme. The reference interval was verified by an indirect estimation on 2445 male and 2838 female outpatients.
Results
The imprecision study showed a coefficient of variation (CV) between 2.7% and 34.7% for serum pools from 16.3 and 0.27 nmol/L. The value of Limit of Quantitation at 20% CV was 0.53 nmol/L. The DHEAS showed a cross‐reaction of 0.0074%. A comparison with LC‐MS showed a trend toward a slight underestimation of immunoassay vs LC‐MS (Passing‐Bablock equations: DxI=−0.24+0.906 LCMS in serum samples and DxI=−0.299+0.981 LCMS in EQA samples). The verification of reference interval showed a 2.5th‐97.5th percentile distribution of 6.6‐24.3 nmol/L for male over 14 years and <0.5‐2.78 nmol/L for female subjects, in accord with the reference intervals reported by the manufacturer.
Conclusions
The Access Testosterone method could be considered an adequately reliable tool for the testosterone measurement.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Chemiluminescence</subject><subject>Chromatography, Liquid - methods</subject><subject>Chromatography, Liquid - standards</subject><subject>cross‐reaction</subject><subject>Dehydroepiandrosterone</subject><subject>DxI platform</subject><subject>Humans</subject><subject>Immunoassay</subject><subject>Immunoassay - methods</subject><subject>Immunoassay - standards</subject><subject>immunoassay method</subject><subject>Liquid chromatography</subject><subject>liquid chromatography‐mass spectrometry</subject><subject>LoQ</subject><subject>Male</subject><subject>Mass Spectrometry - methods</subject><subject>Mass Spectrometry - standards</subject><subject>Mass spectroscopy</subject><subject>Mathematical models</subject><subject>Middle Aged</subject><subject>Quality assurance</subject><subject>Quantitation</subject><subject>Reference Values</subject><subject>Reproducibility of Results</subject><subject>Sensitivity and Specificity</subject><subject>Sulfate</subject><subject>Testosterone</subject><subject>Testosterone - blood</subject><subject>Young Adult</subject><issn>0887-8013</issn><issn>1098-2825</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kd9uFCEYxUmjadfamz6AIfHGmEwLDDPD3JhsNv7NmiZarwkDHw6bGdjCjM3e-Qg-o08i69ameuEVBH6c7xwOQueUXFBC2OVGD-qCMSbqI7SgpBUFE6x6hBZEiKYQhJYn6ElKG0KIaGl9jE4yyktOqgXqPoFKCVIawU84WDz1gJda5xN8DWkKaYIYPGDdw-iGeXQekgavAed3aoeVN1iHcauiS8HjWzf1eL36-f3Hx894hKkP5il6bNWQ4OxuPUVf3ry-Xr0r1ldv36-W60JzLuqCdjUVGgivO8MZayowzFSlMaUFq1rFFeHUqK5r84a1XWmZrW1Ham2EIZaXp-jVQXc7dyOYbHKKapDb6EYVdzIoJ_--8a6XX8M3WQvaUCGywIs7gRhu5hxeji5nHQblIcxJ0paWZds2ZD_r-T_oJszR53iS5f9uqooylqmXB0rHkFIEe2-GErmvTu6rk7-ry_Czh_bv0T9dZYAegFs3wO4_UvLDar08iP4COXOnHQ</recordid><startdate>201803</startdate><enddate>201803</enddate><creator>Dittadi, Ruggero</creator><creator>Matteucci, Mara</creator><creator>Meneghetti, Elisa</creator><creator>Ndreu, Rudina</creator><general>John Wiley & Sons, Inc</general><general>John Wiley and Sons Inc</general><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>7QP</scope><scope>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-2274-9648</orcidid></search><sort><creationdate>201803</creationdate><title>Reassessment of the Access Testosterone chemiluminescence assay and comparison with LC‐MS method</title><author>Dittadi, Ruggero ; Matteucci, Mara ; Meneghetti, Elisa ; Ndreu, Rudina</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4486-1b618ce046bd42275ed2d53dd3fefa9a4a041dabb9a0429b3f2f6fb06cd8d0f43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Chemiluminescence</topic><topic>Chromatography, Liquid - methods</topic><topic>Chromatography, Liquid - standards</topic><topic>cross‐reaction</topic><topic>Dehydroepiandrosterone</topic><topic>DxI platform</topic><topic>Humans</topic><topic>Immunoassay</topic><topic>Immunoassay - methods</topic><topic>Immunoassay - standards</topic><topic>immunoassay method</topic><topic>Liquid chromatography</topic><topic>liquid chromatography‐mass spectrometry</topic><topic>LoQ</topic><topic>Male</topic><topic>Mass Spectrometry - methods</topic><topic>Mass Spectrometry - standards</topic><topic>Mass spectroscopy</topic><topic>Mathematical models</topic><topic>Middle Aged</topic><topic>Quality assurance</topic><topic>Quantitation</topic><topic>Reference Values</topic><topic>Reproducibility of Results</topic><topic>Sensitivity and Specificity</topic><topic>Sulfate</topic><topic>Testosterone</topic><topic>Testosterone - blood</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dittadi, Ruggero</creatorcontrib><creatorcontrib>Matteucci, Mara</creatorcontrib><creatorcontrib>Meneghetti, Elisa</creatorcontrib><creatorcontrib>Ndreu, Rudina</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of clinical laboratory analysis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dittadi, Ruggero</au><au>Matteucci, Mara</au><au>Meneghetti, Elisa</au><au>Ndreu, Rudina</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Reassessment of the Access Testosterone chemiluminescence assay and comparison with LC‐MS method</atitle><jtitle>Journal of clinical laboratory analysis</jtitle><addtitle>J Clin Lab Anal</addtitle><date>2018-03</date><risdate>2018</risdate><volume>32</volume><issue>3</issue><epage>n/a</epage><issn>0887-8013</issn><eissn>1098-2825</eissn><abstract>Aim of the study
To reassess the imprecision and Limit of Quantitation, to evaluate the cross‐reaction with dehydroepiandrosterone‐sulfate (DHEAS), the accuracy toward liquid chromatography‐mass spectrometry (LC‐MS) and the reference interval of the Access Testosterone method, performed by DxI immunoassay platform (Beckman Coulter).
Material and Methods
Imprecision was evaluated testing six pool samples assayed in 20 different run using two reagents lots. The cross‐reaction with DHEAS was studied both by a displacement curve and by spiking DHEAS standard in two serum samples with known amount of testosterone. The comparison with LC‐MS was evaluated by Passing‐Bablock analysis in 21 routine serum samples and 19 control samples from an External Quality Assurance (EQA) scheme. The reference interval was verified by an indirect estimation on 2445 male and 2838 female outpatients.
Results
The imprecision study showed a coefficient of variation (CV) between 2.7% and 34.7% for serum pools from 16.3 and 0.27 nmol/L. The value of Limit of Quantitation at 20% CV was 0.53 nmol/L. The DHEAS showed a cross‐reaction of 0.0074%. A comparison with LC‐MS showed a trend toward a slight underestimation of immunoassay vs LC‐MS (Passing‐Bablock equations: DxI=−0.24+0.906 LCMS in serum samples and DxI=−0.299+0.981 LCMS in EQA samples). The verification of reference interval showed a 2.5th‐97.5th percentile distribution of 6.6‐24.3 nmol/L for male over 14 years and <0.5‐2.78 nmol/L for female subjects, in accord with the reference intervals reported by the manufacturer.
Conclusions
The Access Testosterone method could be considered an adequately reliable tool for the testosterone measurement.</abstract><cop>United States</cop><pub>John Wiley & Sons, Inc</pub><pmid>28643405</pmid><doi>10.1002/jcla.22286</doi><tpages>5</tpages><orcidid>https://orcid.org/0000-0003-2274-9648</orcidid><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central |
| subjects | Adolescent Adult Aged Aged, 80 and over Chemiluminescence Chromatography, Liquid - methods Chromatography, Liquid - standards cross‐reaction Dehydroepiandrosterone DxI platform Humans Immunoassay Immunoassay - methods Immunoassay - standards immunoassay method Liquid chromatography liquid chromatography‐mass spectrometry LoQ Male Mass Spectrometry - methods Mass Spectrometry - standards Mass spectroscopy Mathematical models Middle Aged Quality assurance Quantitation Reference Values Reproducibility of Results Sensitivity and Specificity Sulfate Testosterone Testosterone - blood Young Adult |
| title | Reassessment of the Access Testosterone chemiluminescence assay and comparison with LC‐MS method |
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