Sample matrix and high-sensitivity cardiac troponin I assays
Background Manufacturers of high-sensitivity cardiac troponin (hs-cTn) assays have restricted use of what sample types or matrices are acceptable to use for measurement. Our goal was to evaluate the comparability of the Siemens ADVIA Centaur hs-cTnI assay across different matrices and under differen...
Gespeichert in:
| Veröffentlicht in: | Clinical chemistry and laboratory medicine 2019-04, Vol.57 (5), p.745-751 |
|---|---|
| Hauptverfasser: | , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 751 |
|---|---|
| container_issue | 5 |
| container_start_page | 745 |
| container_title | Clinical chemistry and laboratory medicine |
| container_volume | 57 |
| creator | Kavsak, Peter A. Roy, Chantele Malinowski, Paul Clark, Lorna Lamers, Shana Bamford, Karen Hill, Stephen Worster, Andrew Jaffe, Allan S. |
| description | Background Manufacturers of high-sensitivity cardiac troponin (hs-cTn) assays have restricted use of what sample types or matrices are acceptable to use for measurement. Our goal was to evaluate the comparability of the Siemens ADVIA Centaur hs-cTnI assay across different matrices and under different storage conditions. Methods Three different QC-plasma matrices were evaluated for imprecision |
| doi_str_mv | 10.1515/cclm-2018-1100 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2188587686</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2188587686</sourcerecordid><originalsourceid>FETCH-LOGICAL-c376t-742a89a3b2897fccad1e426d0ea46ff628e59d293a3585768d2dc3be6055235c3</originalsourceid><addsrcrecordid>eNptkDtPwzAURi0EoqWwMqJILCwpfseRuqCKR6VKDMBsubbTusoLOwHy70loAQkx3Tuc77tXB4BzBKeIIXatdV7EGCIRIwThARgjSpKYEoIOv3Yac47RCJyEsIUQMUaTYzAiUBAhKB6D2ZMq6txGhWq8-4hUaaKNW2_iYMvgGvfmmi7SyhundNT4qq5KV0aLSIWgunAKjjKVB3u2nxPwcnf7PH-Il4_3i_nNMtYk4U2cUKxEqsgKizTJtFYGWYq5gVZRnmUcC8tSg1OiCBMs4cJgo8nKcsgYJkyTCbja9da-em1taGThgrZ5rkpbtUFiJAQTfZD36OUfdFu1vuy_kxhDIjBFlPXUdEdpX4XgbSZr7wrlO4mgHLzKwascvMrBax-42Ne2q8KaH_xbZA_MdsC7yhvrjV37tuuX3_P_N7OEJf1Dnxc9hek</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2203824145</pqid></control><display><type>article</type><title>Sample matrix and high-sensitivity cardiac troponin I assays</title><source>MEDLINE</source><source>De Gruyter journals</source><creator>Kavsak, Peter A. ; Roy, Chantele ; Malinowski, Paul ; Clark, Lorna ; Lamers, Shana ; Bamford, Karen ; Hill, Stephen ; Worster, Andrew ; Jaffe, Allan S.</creator><creatorcontrib>Kavsak, Peter A. ; Roy, Chantele ; Malinowski, Paul ; Clark, Lorna ; Lamers, Shana ; Bamford, Karen ; Hill, Stephen ; Worster, Andrew ; Jaffe, Allan S.</creatorcontrib><description>Background Manufacturers of high-sensitivity cardiac troponin (hs-cTn) assays have restricted use of what sample types or matrices are acceptable to use for measurement. Our goal was to evaluate the comparability of the Siemens ADVIA Centaur hs-cTnI assay across different matrices and under different storage conditions. Methods Three different QC-plasma matrices were evaluated for imprecision <10 ng/L. Passing-Bablok regression and difference plots were determined for cTnI concentrations spanning the reference interval (limit of quantification to male 99th-percentile: 2.5 ng/L to <60 ng/L) between serum and lithium heparin plasma, lithium heparin and EDTA plasma and between the Siemens and Abbott hs-cTnI assays. Stability at room temperature (RT) and 2-8 °C was also assessed across the three matrices. Results Over 16-weeks the SDs were ≤1.0 ng/L for QCs ranging from 5.0 to 8.3 ng/L. Across the reference interval there was excellent agreement between lithium heparin plasma and serum for the Siemens hs-cTnI assay (slope=0.98/intercept=-0.1), however, cTnI concentrations were proportionally lower in EDTA as compared to lithium heparin plasma (slope=0.90, 95% CI: 0.88-0.92). In lithium heparin plasma the Siemens hs-cTnI concentrations were higher than the Abbott hs-cTnI concentrations (slope=1.26/intercept=-0.2). Stability of cTnI in lithium heparin plasma as compared in serum and EDTA plasma appeared more labile, with decreases ≥20% in concentrations evident as early as 1-day in storage at RT. Conclusions There is excellent agreement in concentrations between lithium heparin plasma and serum with the Siemens ADVIA Centaur hs-cTnI assay; however, cTnI concentrations in EDTA plasma are lower. Reference intervals and clinical studies in EDTA plasma for the Centaur hs-cTnI assay are required before clinical use.</description><identifier>ISSN: 1434-6621</identifier><identifier>EISSN: 1437-4331</identifier><identifier>DOI: 10.1515/cclm-2018-1100</identifier><identifier>PMID: 30838842</identifier><language>eng</language><publisher>Germany: De Gruyter</publisher><subject>analytical variation ; Anticoagulants ; Assaying ; Blood Chemical Analysis - standards ; Blood Specimen Collection ; Calcium-binding protein ; Edetic acid ; Edetic Acid - chemistry ; EDTA plasma ; Ethylenediaminetetraacetic acids ; Heart ; Heparin ; Heparin - chemistry ; high-sensitivity cardiac troponin ; Humans ; Immunoassay - standards ; Lithium ; lithium heparin plasma ; matrix ; Plasma ; Quality Control ; Reference Values ; Sensitivity ; serum ; Slope stability ; stability ; Stability analysis ; Storage ; Storage conditions ; Troponin ; Troponin I ; Troponin I - blood</subject><ispartof>Clinical chemistry and laboratory medicine, 2019-04, Vol.57 (5), p.745-751</ispartof><rights>2019 Walter de Gruyter GmbH, Berlin/Boston</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c376t-742a89a3b2897fccad1e426d0ea46ff628e59d293a3585768d2dc3be6055235c3</citedby><cites>FETCH-LOGICAL-c376t-742a89a3b2897fccad1e426d0ea46ff628e59d293a3585768d2dc3be6055235c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.degruyter.com/document/doi/10.1515/cclm-2018-1100/pdf$$EPDF$$P50$$Gwalterdegruyter$$H</linktopdf><linktohtml>$$Uhttps://www.degruyter.com/document/doi/10.1515/cclm-2018-1100/html$$EHTML$$P50$$Gwalterdegruyter$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,66497,68281</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30838842$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kavsak, Peter A.</creatorcontrib><creatorcontrib>Roy, Chantele</creatorcontrib><creatorcontrib>Malinowski, Paul</creatorcontrib><creatorcontrib>Clark, Lorna</creatorcontrib><creatorcontrib>Lamers, Shana</creatorcontrib><creatorcontrib>Bamford, Karen</creatorcontrib><creatorcontrib>Hill, Stephen</creatorcontrib><creatorcontrib>Worster, Andrew</creatorcontrib><creatorcontrib>Jaffe, Allan S.</creatorcontrib><title>Sample matrix and high-sensitivity cardiac troponin I assays</title><title>Clinical chemistry and laboratory medicine</title><addtitle>Clin Chem Lab Med</addtitle><description>Background Manufacturers of high-sensitivity cardiac troponin (hs-cTn) assays have restricted use of what sample types or matrices are acceptable to use for measurement. Our goal was to evaluate the comparability of the Siemens ADVIA Centaur hs-cTnI assay across different matrices and under different storage conditions. Methods Three different QC-plasma matrices were evaluated for imprecision <10 ng/L. Passing-Bablok regression and difference plots were determined for cTnI concentrations spanning the reference interval (limit of quantification to male 99th-percentile: 2.5 ng/L to <60 ng/L) between serum and lithium heparin plasma, lithium heparin and EDTA plasma and between the Siemens and Abbott hs-cTnI assays. Stability at room temperature (RT) and 2-8 °C was also assessed across the three matrices. Results Over 16-weeks the SDs were ≤1.0 ng/L for QCs ranging from 5.0 to 8.3 ng/L. Across the reference interval there was excellent agreement between lithium heparin plasma and serum for the Siemens hs-cTnI assay (slope=0.98/intercept=-0.1), however, cTnI concentrations were proportionally lower in EDTA as compared to lithium heparin plasma (slope=0.90, 95% CI: 0.88-0.92). In lithium heparin plasma the Siemens hs-cTnI concentrations were higher than the Abbott hs-cTnI concentrations (slope=1.26/intercept=-0.2). Stability of cTnI in lithium heparin plasma as compared in serum and EDTA plasma appeared more labile, with decreases ≥20% in concentrations evident as early as 1-day in storage at RT. Conclusions There is excellent agreement in concentrations between lithium heparin plasma and serum with the Siemens ADVIA Centaur hs-cTnI assay; however, cTnI concentrations in EDTA plasma are lower. Reference intervals and clinical studies in EDTA plasma for the Centaur hs-cTnI assay are required before clinical use.</description><subject>analytical variation</subject><subject>Anticoagulants</subject><subject>Assaying</subject><subject>Blood Chemical Analysis - standards</subject><subject>Blood Specimen Collection</subject><subject>Calcium-binding protein</subject><subject>Edetic acid</subject><subject>Edetic Acid - chemistry</subject><subject>EDTA plasma</subject><subject>Ethylenediaminetetraacetic acids</subject><subject>Heart</subject><subject>Heparin</subject><subject>Heparin - chemistry</subject><subject>high-sensitivity cardiac troponin</subject><subject>Humans</subject><subject>Immunoassay - standards</subject><subject>Lithium</subject><subject>lithium heparin plasma</subject><subject>matrix</subject><subject>Plasma</subject><subject>Quality Control</subject><subject>Reference Values</subject><subject>Sensitivity</subject><subject>serum</subject><subject>Slope stability</subject><subject>stability</subject><subject>Stability analysis</subject><subject>Storage</subject><subject>Storage conditions</subject><subject>Troponin</subject><subject>Troponin I</subject><subject>Troponin I - blood</subject><issn>1434-6621</issn><issn>1437-4331</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNptkDtPwzAURi0EoqWwMqJILCwpfseRuqCKR6VKDMBsubbTusoLOwHy70loAQkx3Tuc77tXB4BzBKeIIXatdV7EGCIRIwThARgjSpKYEoIOv3Yac47RCJyEsIUQMUaTYzAiUBAhKB6D2ZMq6txGhWq8-4hUaaKNW2_iYMvgGvfmmi7SyhundNT4qq5KV0aLSIWgunAKjjKVB3u2nxPwcnf7PH-Il4_3i_nNMtYk4U2cUKxEqsgKizTJtFYGWYq5gVZRnmUcC8tSg1OiCBMs4cJgo8nKcsgYJkyTCbja9da-em1taGThgrZ5rkpbtUFiJAQTfZD36OUfdFu1vuy_kxhDIjBFlPXUdEdpX4XgbSZr7wrlO4mgHLzKwascvMrBax-42Ne2q8KaH_xbZA_MdsC7yhvrjV37tuuX3_P_N7OEJf1Dnxc9hek</recordid><startdate>20190424</startdate><enddate>20190424</enddate><creator>Kavsak, Peter A.</creator><creator>Roy, Chantele</creator><creator>Malinowski, Paul</creator><creator>Clark, Lorna</creator><creator>Lamers, Shana</creator><creator>Bamford, Karen</creator><creator>Hill, Stephen</creator><creator>Worster, Andrew</creator><creator>Jaffe, Allan S.</creator><general>De Gruyter</general><general>Walter De Gruyter & Company</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>7QO</scope><scope>7T7</scope><scope>7TK</scope><scope>7U7</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>20190424</creationdate><title>Sample matrix and high-sensitivity cardiac troponin I assays</title><author>Kavsak, Peter A. ; Roy, Chantele ; Malinowski, Paul ; Clark, Lorna ; Lamers, Shana ; Bamford, Karen ; Hill, Stephen ; Worster, Andrew ; Jaffe, Allan S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c376t-742a89a3b2897fccad1e426d0ea46ff628e59d293a3585768d2dc3be6055235c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>analytical variation</topic><topic>Anticoagulants</topic><topic>Assaying</topic><topic>Blood Chemical Analysis - standards</topic><topic>Blood Specimen Collection</topic><topic>Calcium-binding protein</topic><topic>Edetic acid</topic><topic>Edetic Acid - chemistry</topic><topic>EDTA plasma</topic><topic>Ethylenediaminetetraacetic acids</topic><topic>Heart</topic><topic>Heparin</topic><topic>Heparin - chemistry</topic><topic>high-sensitivity cardiac troponin</topic><topic>Humans</topic><topic>Immunoassay - standards</topic><topic>Lithium</topic><topic>lithium heparin plasma</topic><topic>matrix</topic><topic>Plasma</topic><topic>Quality Control</topic><topic>Reference Values</topic><topic>Sensitivity</topic><topic>serum</topic><topic>Slope stability</topic><topic>stability</topic><topic>Stability analysis</topic><topic>Storage</topic><topic>Storage conditions</topic><topic>Troponin</topic><topic>Troponin I</topic><topic>Troponin I - blood</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kavsak, Peter A.</creatorcontrib><creatorcontrib>Roy, Chantele</creatorcontrib><creatorcontrib>Malinowski, Paul</creatorcontrib><creatorcontrib>Clark, Lorna</creatorcontrib><creatorcontrib>Lamers, Shana</creatorcontrib><creatorcontrib>Bamford, Karen</creatorcontrib><creatorcontrib>Hill, Stephen</creatorcontrib><creatorcontrib>Worster, Andrew</creatorcontrib><creatorcontrib>Jaffe, Allan S.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical chemistry and laboratory medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kavsak, Peter A.</au><au>Roy, Chantele</au><au>Malinowski, Paul</au><au>Clark, Lorna</au><au>Lamers, Shana</au><au>Bamford, Karen</au><au>Hill, Stephen</au><au>Worster, Andrew</au><au>Jaffe, Allan S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Sample matrix and high-sensitivity cardiac troponin I assays</atitle><jtitle>Clinical chemistry and laboratory medicine</jtitle><addtitle>Clin Chem Lab Med</addtitle><date>2019-04-24</date><risdate>2019</risdate><volume>57</volume><issue>5</issue><spage>745</spage><epage>751</epage><pages>745-751</pages><issn>1434-6621</issn><eissn>1437-4331</eissn><abstract>Background Manufacturers of high-sensitivity cardiac troponin (hs-cTn) assays have restricted use of what sample types or matrices are acceptable to use for measurement. Our goal was to evaluate the comparability of the Siemens ADVIA Centaur hs-cTnI assay across different matrices and under different storage conditions. Methods Three different QC-plasma matrices were evaluated for imprecision <10 ng/L. Passing-Bablok regression and difference plots were determined for cTnI concentrations spanning the reference interval (limit of quantification to male 99th-percentile: 2.5 ng/L to <60 ng/L) between serum and lithium heparin plasma, lithium heparin and EDTA plasma and between the Siemens and Abbott hs-cTnI assays. Stability at room temperature (RT) and 2-8 °C was also assessed across the three matrices. Results Over 16-weeks the SDs were ≤1.0 ng/L for QCs ranging from 5.0 to 8.3 ng/L. Across the reference interval there was excellent agreement between lithium heparin plasma and serum for the Siemens hs-cTnI assay (slope=0.98/intercept=-0.1), however, cTnI concentrations were proportionally lower in EDTA as compared to lithium heparin plasma (slope=0.90, 95% CI: 0.88-0.92). In lithium heparin plasma the Siemens hs-cTnI concentrations were higher than the Abbott hs-cTnI concentrations (slope=1.26/intercept=-0.2). Stability of cTnI in lithium heparin plasma as compared in serum and EDTA plasma appeared more labile, with decreases ≥20% in concentrations evident as early as 1-day in storage at RT. Conclusions There is excellent agreement in concentrations between lithium heparin plasma and serum with the Siemens ADVIA Centaur hs-cTnI assay; however, cTnI concentrations in EDTA plasma are lower. Reference intervals and clinical studies in EDTA plasma for the Centaur hs-cTnI assay are required before clinical use.</abstract><cop>Germany</cop><pub>De Gruyter</pub><pmid>30838842</pmid><doi>10.1515/cclm-2018-1100</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1434-6621 |
| ispartof | Clinical chemistry and laboratory medicine, 2019-04, Vol.57 (5), p.745-751 |
| issn | 1434-6621 1437-4331 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2188587686 |
| source | MEDLINE; De Gruyter journals |
| subjects | analytical variation Anticoagulants Assaying Blood Chemical Analysis - standards Blood Specimen Collection Calcium-binding protein Edetic acid Edetic Acid - chemistry EDTA plasma Ethylenediaminetetraacetic acids Heart Heparin Heparin - chemistry high-sensitivity cardiac troponin Humans Immunoassay - standards Lithium lithium heparin plasma matrix Plasma Quality Control Reference Values Sensitivity serum Slope stability stability Stability analysis Storage Storage conditions Troponin Troponin I Troponin I - blood |
| title | Sample matrix and high-sensitivity cardiac troponin I assays |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-07T10%3A30%3A33IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Sample%20matrix%20and%20high-sensitivity%20cardiac%20troponin%20I%20assays&rft.jtitle=Clinical%20chemistry%20and%20laboratory%20medicine&rft.au=Kavsak,%20Peter%20A.&rft.date=2019-04-24&rft.volume=57&rft.issue=5&rft.spage=745&rft.epage=751&rft.pages=745-751&rft.issn=1434-6621&rft.eissn=1437-4331&rft_id=info:doi/10.1515/cclm-2018-1100&rft_dat=%3Cproquest_cross%3E2188587686%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2203824145&rft_id=info:pmid/30838842&rfr_iscdi=true |