Performance characteristics of the Beckman Coulter UniCel DxI 800 TSH (3rd IS) assay
Beckman Coulter recently reformulated their commercial TSH assay with primary calibration to the World Health Organization 3rd TSH international standard. An extensive evaluation of the performance characteristics for this assay was completed. Intra-day and inter-day precision was evaluated using 3...
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| Veröffentlicht in: | Clinica chimica acta 2018-03, Vol.478, p.90-100 |
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| container_title | Clinica chimica acta |
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| creator | Winston-McPherson, Gabrielle N. Samraj, Annie N. Poster, Kristina Yamaguchi, Diane Dickerson, Jane A. Drees, Julia C. Holmes, Daniel T. Greene, Dina N. |
| description | Beckman Coulter recently reformulated their commercial TSH assay with primary calibration to the World Health Organization 3rd TSH international standard. An extensive evaluation of the performance characteristics for this assay was completed.
Intra-day and inter-day precision was evaluated using 3 concentrations of commercial quality control material. Linearity, reportable range, stability, sensitivity and susceptibility to common inferences were determined using pooled patient specimens. Inter-assay variability was assessed across 5 different platforms (n=47 patient specimens).
Intra-day and inter-day CVs were |
| doi_str_mv | 10.1016/j.cca.2017.12.029 |
| format | Article |
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Intra-day and inter-day precision was evaluated using 3 concentrations of commercial quality control material. Linearity, reportable range, stability, sensitivity and susceptibility to common inferences were determined using pooled patient specimens. Inter-assay variability was assessed across 5 different platforms (n=47 patient specimens).
Intra-day and inter-day CVs were <10% at all concentrations evaluated. The LOQ, LOD and LOB were 0.0047μIU/ml (10% CV), 0.0012μIU/ml and 0.0005μIU/ml, respectively. Variable bias was observed for the TSH3 assay when evaluated against the previous generation assay and other platforms, but overall TSH3 gave comparable results.
The TSH3 assay for UniCel DxI 800, is precise, highly sensitive and comparable to the previous generation assay. The assay is acceptable for clinical testing.
•Beckman Coulter reformulated their commercial TSH assay (TSH3).•A comprehensive evaluation of TSH3 was completed.•TSH3 produced comparable results when evaluated against 5 other TSH assays.•TSH demonstrated acceptable intra-day and inter-day (<10%) precision.•TSH3 performs with improved precision and sensitivity.</description><identifier>ISSN: 0009-8981</identifier><identifier>EISSN: 1873-3492</identifier><identifier>DOI: 10.1016/j.cca.2017.12.029</identifier><identifier>PMID: 29275143</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>3rd IS ; Access ; Beckman Coulter ; Bias ; Calibration ; Clinical Laboratory Techniques - instrumentation ; Clinical Laboratory Techniques - standards ; DxI ; Harmonization ; Humans ; Immunoassay ; Quality Control ; Reproducibility of Results ; Thyrotropin - analysis ; TSH ; Validation</subject><ispartof>Clinica chimica acta, 2018-03, Vol.478, p.90-100</ispartof><rights>2018 Elsevier B.V.</rights><rights>Copyright © 2018 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c419t-2aa1ea5fcd061ffa0b517a40597270d0fb62cfcc64f77bffd41c4103d769e6183</citedby><cites>FETCH-LOGICAL-c419t-2aa1ea5fcd061ffa0b517a40597270d0fb62cfcc64f77bffd41c4103d769e6183</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0009898117305296$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29275143$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Winston-McPherson, Gabrielle N.</creatorcontrib><creatorcontrib>Samraj, Annie N.</creatorcontrib><creatorcontrib>Poster, Kristina</creatorcontrib><creatorcontrib>Yamaguchi, Diane</creatorcontrib><creatorcontrib>Dickerson, Jane A.</creatorcontrib><creatorcontrib>Drees, Julia C.</creatorcontrib><creatorcontrib>Holmes, Daniel T.</creatorcontrib><creatorcontrib>Greene, Dina N.</creatorcontrib><title>Performance characteristics of the Beckman Coulter UniCel DxI 800 TSH (3rd IS) assay</title><title>Clinica chimica acta</title><addtitle>Clin Chim Acta</addtitle><description>Beckman Coulter recently reformulated their commercial TSH assay with primary calibration to the World Health Organization 3rd TSH international standard. An extensive evaluation of the performance characteristics for this assay was completed.
Intra-day and inter-day precision was evaluated using 3 concentrations of commercial quality control material. Linearity, reportable range, stability, sensitivity and susceptibility to common inferences were determined using pooled patient specimens. Inter-assay variability was assessed across 5 different platforms (n=47 patient specimens).
Intra-day and inter-day CVs were <10% at all concentrations evaluated. The LOQ, LOD and LOB were 0.0047μIU/ml (10% CV), 0.0012μIU/ml and 0.0005μIU/ml, respectively. Variable bias was observed for the TSH3 assay when evaluated against the previous generation assay and other platforms, but overall TSH3 gave comparable results.
The TSH3 assay for UniCel DxI 800, is precise, highly sensitive and comparable to the previous generation assay. The assay is acceptable for clinical testing.
•Beckman Coulter reformulated their commercial TSH assay (TSH3).•A comprehensive evaluation of TSH3 was completed.•TSH3 produced comparable results when evaluated against 5 other TSH assays.•TSH demonstrated acceptable intra-day and inter-day (<10%) precision.•TSH3 performs with improved precision and sensitivity.</description><subject>3rd IS</subject><subject>Access</subject><subject>Beckman Coulter</subject><subject>Bias</subject><subject>Calibration</subject><subject>Clinical Laboratory Techniques - instrumentation</subject><subject>Clinical Laboratory Techniques - standards</subject><subject>DxI</subject><subject>Harmonization</subject><subject>Humans</subject><subject>Immunoassay</subject><subject>Quality Control</subject><subject>Reproducibility of Results</subject><subject>Thyrotropin - analysis</subject><subject>TSH</subject><subject>Validation</subject><issn>0009-8981</issn><issn>1873-3492</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kMtOwzAQRS0EgvL4ADbIS1gkzDhpHIsVlFclJJDari3XGQuXtAE7RfD3GBVYsrJGPvdq5jB2jJAjYHW-yK01uQCUOYochNpiA6xlkRWlEttsAAAqq1WNe2w_xkUaS6hwl-0JJeQQy2LApk8UXBeWZmWJ22cTjO0p-Nh7G3nneP9M_IrsSwL4qFu36ZPPVn5ELb_-GPMagE8n9_y0CA0fT864idF8HrIdZ9pIRz_vAZvd3kxH99nD4914dPmQ2RJVnwljkMzQ2SZt5ZyB-RClKWGopJDQgJtXwjprq9JJOXeuKTEFoWhkpajCujhgp5ve19C9rSn2eumjpbY1K-rWUaOqAUFIAQnFDWpDF2Mgp1-DX5rwqRH0t0y90Emm_papUegkM2VOfurX8yU1f4lfewm42ACUjnz3FHS0npLJxgeyvW46_0_9FyDVgmM</recordid><startdate>201803</startdate><enddate>201803</enddate><creator>Winston-McPherson, Gabrielle N.</creator><creator>Samraj, Annie N.</creator><creator>Poster, Kristina</creator><creator>Yamaguchi, Diane</creator><creator>Dickerson, Jane A.</creator><creator>Drees, Julia C.</creator><creator>Holmes, Daniel T.</creator><creator>Greene, Dina N.</creator><general>Elsevier B.V</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>7X8</scope></search><sort><creationdate>201803</creationdate><title>Performance characteristics of the Beckman Coulter UniCel DxI 800 TSH (3rd IS) assay</title><author>Winston-McPherson, Gabrielle N. ; Samraj, Annie N. ; Poster, Kristina ; Yamaguchi, Diane ; Dickerson, Jane A. ; Drees, Julia C. ; Holmes, Daniel T. ; Greene, Dina N.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c419t-2aa1ea5fcd061ffa0b517a40597270d0fb62cfcc64f77bffd41c4103d769e6183</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>3rd IS</topic><topic>Access</topic><topic>Beckman Coulter</topic><topic>Bias</topic><topic>Calibration</topic><topic>Clinical Laboratory Techniques - instrumentation</topic><topic>Clinical Laboratory Techniques - standards</topic><topic>DxI</topic><topic>Harmonization</topic><topic>Humans</topic><topic>Immunoassay</topic><topic>Quality Control</topic><topic>Reproducibility of Results</topic><topic>Thyrotropin - analysis</topic><topic>TSH</topic><topic>Validation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Winston-McPherson, Gabrielle N.</creatorcontrib><creatorcontrib>Samraj, Annie N.</creatorcontrib><creatorcontrib>Poster, Kristina</creatorcontrib><creatorcontrib>Yamaguchi, Diane</creatorcontrib><creatorcontrib>Dickerson, Jane A.</creatorcontrib><creatorcontrib>Drees, Julia C.</creatorcontrib><creatorcontrib>Holmes, Daniel T.</creatorcontrib><creatorcontrib>Greene, Dina N.</creatorcontrib><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>Clinica chimica acta</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Winston-McPherson, Gabrielle N.</au><au>Samraj, Annie N.</au><au>Poster, Kristina</au><au>Yamaguchi, Diane</au><au>Dickerson, Jane A.</au><au>Drees, Julia C.</au><au>Holmes, Daniel T.</au><au>Greene, Dina N.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Performance characteristics of the Beckman Coulter UniCel DxI 800 TSH (3rd IS) assay</atitle><jtitle>Clinica chimica acta</jtitle><addtitle>Clin Chim Acta</addtitle><date>2018-03</date><risdate>2018</risdate><volume>478</volume><spage>90</spage><epage>100</epage><pages>90-100</pages><issn>0009-8981</issn><eissn>1873-3492</eissn><abstract>Beckman Coulter recently reformulated their commercial TSH assay with primary calibration to the World Health Organization 3rd TSH international standard. An extensive evaluation of the performance characteristics for this assay was completed.
Intra-day and inter-day precision was evaluated using 3 concentrations of commercial quality control material. Linearity, reportable range, stability, sensitivity and susceptibility to common inferences were determined using pooled patient specimens. Inter-assay variability was assessed across 5 different platforms (n=47 patient specimens).
Intra-day and inter-day CVs were <10% at all concentrations evaluated. The LOQ, LOD and LOB were 0.0047μIU/ml (10% CV), 0.0012μIU/ml and 0.0005μIU/ml, respectively. Variable bias was observed for the TSH3 assay when evaluated against the previous generation assay and other platforms, but overall TSH3 gave comparable results.
The TSH3 assay for UniCel DxI 800, is precise, highly sensitive and comparable to the previous generation assay. The assay is acceptable for clinical testing.
•Beckman Coulter reformulated their commercial TSH assay (TSH3).•A comprehensive evaluation of TSH3 was completed.•TSH3 produced comparable results when evaluated against 5 other TSH assays.•TSH demonstrated acceptable intra-day and inter-day (<10%) precision.•TSH3 performs with improved precision and sensitivity.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>29275143</pmid><doi>10.1016/j.cca.2017.12.029</doi><tpages>11</tpages></addata></record> |
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| subjects | 3rd IS Access Beckman Coulter Bias Calibration Clinical Laboratory Techniques - instrumentation Clinical Laboratory Techniques - standards DxI Harmonization Humans Immunoassay Quality Control Reproducibility of Results Thyrotropin - analysis TSH Validation |
| title | Performance characteristics of the Beckman Coulter UniCel DxI 800 TSH (3rd IS) assay |
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