Evaluation of a new soluble transferrin receptor assay and comparison to three measurement procedures
•A new soluble transferrin receptor (sTfR) immunoturbidimetric assay was evaluated.•Comparisons to three measurement procedures demonstrated high correlation (r > 0.975).•Variable analytical bias was observed ranging from 0.44 to 1.24 mg/L.•Agreement in interpretation was moderate ranging from 74...
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| Veröffentlicht in: | Clinical biochemistry 2025-01, Vol.135, p.110862, Article 110862 |
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| creator | Bohn, Mary Kathryn Berman, Marvin Ali, Salman Cheng, Pow Lee Wang, Xiao Yan Schneider, Randal J. Kulasingam, Vathany |
| description | •A new soluble transferrin receptor (sTfR) immunoturbidimetric assay was evaluated.•Comparisons to three measurement procedures demonstrated high correlation (r > 0.975).•Variable analytical bias was observed ranging from 0.44 to 1.24 mg/L.•Agreement in interpretation was moderate ranging from 74.2 to 80.5%.•Findings underline need for method-specific consideration of sTfR measurement and interpretation.
Soluble transferrin receptor (sTfR) is a useful marker in the differentiation of anemia. Clinical utility is limited by lack of standardization between measurement procedures and interpretative recommendations. Our objective was to evaluate the analytical performance of a research sTfR immunoturbidimetric assay (Alinity c, Abbott Diagnostics) and compare it to three established measurement procedures.
Assay imprecision was assessed with 7 panels across the analytical measuring interval. 159 patient samples were measured across four instrument systems (Alinity c [Abbott Diagnostics], Tina-quant c502 [Roche Diagnostics], Quantex Biokit [Werfen], and ACCESS [Beckman Coulter]). Ferritin was also measured to calculate an sTfR/Log Ferritin ratio. Sera from 100 reference individuals were assayed for sTfR and ferritin (Alinity) for reference interval (RI) verification (sTfR) or establishment (sTfR index).
Assay imprecision met defined goals. Method comparison between Alinity c and ACCESS sTfR assays showed good agreement (slope: 1.06, intercept: −0.12, r: 0.989). Comparisons across other assays demonstrated significant proportional bias with slopes ranging from 0.44 (Tina-quant c502, mean bias: −2.52 mg/L) to 1.24 (Quantex Biokit, mean bias: 0.60 mg/L). A proportional bias was observed between other instruments. While the sTfR RI was verified on the Alinity assay, agreement in interpretation (within vs outside RI) between Alinity and other platforms ranged from 74.2 to 80.5 %.
We report the first characterization of the performance of a research sTfR immunoturbidimetric assay (Alinity c, Abbott Diagnostics). Our findings emphasize the lack of harmonization between measurement procedures and result interpretation for sTfR and sTfR index, necessitating standardization efforts and clinical studies. |
| doi_str_mv | 10.1016/j.clinbiochem.2024.110862 |
| format | Article |
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Soluble transferrin receptor (sTfR) is a useful marker in the differentiation of anemia. Clinical utility is limited by lack of standardization between measurement procedures and interpretative recommendations. Our objective was to evaluate the analytical performance of a research sTfR immunoturbidimetric assay (Alinity c, Abbott Diagnostics) and compare it to three established measurement procedures.
Assay imprecision was assessed with 7 panels across the analytical measuring interval. 159 patient samples were measured across four instrument systems (Alinity c [Abbott Diagnostics], Tina-quant c502 [Roche Diagnostics], Quantex Biokit [Werfen], and ACCESS [Beckman Coulter]). Ferritin was also measured to calculate an sTfR/Log Ferritin ratio. Sera from 100 reference individuals were assayed for sTfR and ferritin (Alinity) for reference interval (RI) verification (sTfR) or establishment (sTfR index).
Assay imprecision met defined goals. Method comparison between Alinity c and ACCESS sTfR assays showed good agreement (slope: 1.06, intercept: −0.12, r: 0.989). Comparisons across other assays demonstrated significant proportional bias with slopes ranging from 0.44 (Tina-quant c502, mean bias: −2.52 mg/L) to 1.24 (Quantex Biokit, mean bias: 0.60 mg/L). A proportional bias was observed between other instruments. While the sTfR RI was verified on the Alinity assay, agreement in interpretation (within vs outside RI) between Alinity and other platforms ranged from 74.2 to 80.5 %.
We report the first characterization of the performance of a research sTfR immunoturbidimetric assay (Alinity c, Abbott Diagnostics). Our findings emphasize the lack of harmonization between measurement procedures and result interpretation for sTfR and sTfR index, necessitating standardization efforts and clinical studies.</description><identifier>ISSN: 0009-9120</identifier><identifier>ISSN: 1873-2933</identifier><identifier>EISSN: 1873-2933</identifier><identifier>DOI: 10.1016/j.clinbiochem.2024.110862</identifier><identifier>PMID: 39653307</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Aged ; Anemia - blood ; Anemia - diagnosis ; Biomarkers - blood ; Female ; Ferritin ; Ferritins - blood ; Humans ; Immunoturbidimetry - methods ; Immunoturbidimetry - standards ; Iron deficiency anemia ; Male ; Method evaluation ; Middle Aged ; Receptors, Transferrin - blood ; Reference Values ; Soluble transferrin receptor</subject><ispartof>Clinical biochemistry, 2025-01, Vol.135, p.110862, Article 110862</ispartof><rights>2024 The Canadian Society of Clinical Chemists</rights><rights>Copyright © 2024 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c251t-ed92cbae1b332d268de325cf3da98f6382c8bcffba151dc98ed60350a37c4d813</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0009912024001565$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27903,27904,65309</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39653307$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bohn, Mary Kathryn</creatorcontrib><creatorcontrib>Berman, Marvin</creatorcontrib><creatorcontrib>Ali, Salman</creatorcontrib><creatorcontrib>Cheng, Pow Lee</creatorcontrib><creatorcontrib>Wang, Xiao Yan</creatorcontrib><creatorcontrib>Schneider, Randal J.</creatorcontrib><creatorcontrib>Kulasingam, Vathany</creatorcontrib><title>Evaluation of a new soluble transferrin receptor assay and comparison to three measurement procedures</title><title>Clinical biochemistry</title><addtitle>Clin Biochem</addtitle><description>•A new soluble transferrin receptor (sTfR) immunoturbidimetric assay was evaluated.•Comparisons to three measurement procedures demonstrated high correlation (r > 0.975).•Variable analytical bias was observed ranging from 0.44 to 1.24 mg/L.•Agreement in interpretation was moderate ranging from 74.2 to 80.5%.•Findings underline need for method-specific consideration of sTfR measurement and interpretation.
Soluble transferrin receptor (sTfR) is a useful marker in the differentiation of anemia. Clinical utility is limited by lack of standardization between measurement procedures and interpretative recommendations. Our objective was to evaluate the analytical performance of a research sTfR immunoturbidimetric assay (Alinity c, Abbott Diagnostics) and compare it to three established measurement procedures.
Assay imprecision was assessed with 7 panels across the analytical measuring interval. 159 patient samples were measured across four instrument systems (Alinity c [Abbott Diagnostics], Tina-quant c502 [Roche Diagnostics], Quantex Biokit [Werfen], and ACCESS [Beckman Coulter]). Ferritin was also measured to calculate an sTfR/Log Ferritin ratio. Sera from 100 reference individuals were assayed for sTfR and ferritin (Alinity) for reference interval (RI) verification (sTfR) or establishment (sTfR index).
Assay imprecision met defined goals. Method comparison between Alinity c and ACCESS sTfR assays showed good agreement (slope: 1.06, intercept: −0.12, r: 0.989). Comparisons across other assays demonstrated significant proportional bias with slopes ranging from 0.44 (Tina-quant c502, mean bias: −2.52 mg/L) to 1.24 (Quantex Biokit, mean bias: 0.60 mg/L). A proportional bias was observed between other instruments. While the sTfR RI was verified on the Alinity assay, agreement in interpretation (within vs outside RI) between Alinity and other platforms ranged from 74.2 to 80.5 %.
We report the first characterization of the performance of a research sTfR immunoturbidimetric assay (Alinity c, Abbott Diagnostics). Our findings emphasize the lack of harmonization between measurement procedures and result interpretation for sTfR and sTfR index, necessitating standardization efforts and clinical studies.</description><subject>Adult</subject><subject>Aged</subject><subject>Anemia - blood</subject><subject>Anemia - diagnosis</subject><subject>Biomarkers - blood</subject><subject>Female</subject><subject>Ferritin</subject><subject>Ferritins - blood</subject><subject>Humans</subject><subject>Immunoturbidimetry - methods</subject><subject>Immunoturbidimetry - standards</subject><subject>Iron deficiency anemia</subject><subject>Male</subject><subject>Method evaluation</subject><subject>Middle Aged</subject><subject>Receptors, Transferrin - blood</subject><subject>Reference Values</subject><subject>Soluble transferrin receptor</subject><issn>0009-9120</issn><issn>1873-2933</issn><issn>1873-2933</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2025</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkMtKAzEUhoMoWi-vIHHnZmouM2lmKcUbCG50HTLJGZoyk9Qko_j2prSKS1eHA99_fs6H0BUlc0qouFnPzeB854JZwThnhNVzSokU7ADNqFzwirWcH6IZIaStWsrICTpNaV1WVktxjE54KxrOyWKG4O5DD5POLngceqyxh0-cwjB1A-ActU89xOg8jmBgk0PEOiX9hbW32IRxo6NLJZoDzqsIgEfQaYowgs94E4MBW7Z0jo56PSS42M8z9HZ_97p8rJ5fHp6Wt8-VYQ3NFdiWmU4D7ThnlglpgbPG9NzqVvaCS2ZkZ_q-07Sh1rQSrCC8IZovTG0l5Wfoene3VL9PkLIaXTIwDNpDmJLitBaCSC7qgrY71MSQUoRebaIbdfxSlKitZbVWfyyrrWW1s1yyl_uaqRvB_iZ_tBZguQOgPPvhIKpkHPhiwxWPWdng_lHzDV1Jlp8</recordid><startdate>202501</startdate><enddate>202501</enddate><creator>Bohn, Mary Kathryn</creator><creator>Berman, Marvin</creator><creator>Ali, Salman</creator><creator>Cheng, Pow Lee</creator><creator>Wang, Xiao Yan</creator><creator>Schneider, Randal J.</creator><creator>Kulasingam, Vathany</creator><general>Elsevier 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>7X8</scope></search><sort><creationdate>202501</creationdate><title>Evaluation of a new soluble transferrin receptor assay and comparison to three measurement procedures</title><author>Bohn, Mary Kathryn ; Berman, Marvin ; Ali, Salman ; Cheng, Pow Lee ; Wang, Xiao Yan ; Schneider, Randal J. ; Kulasingam, Vathany</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c251t-ed92cbae1b332d268de325cf3da98f6382c8bcffba151dc98ed60350a37c4d813</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2025</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Anemia - blood</topic><topic>Anemia - diagnosis</topic><topic>Biomarkers - blood</topic><topic>Female</topic><topic>Ferritin</topic><topic>Ferritins - blood</topic><topic>Humans</topic><topic>Immunoturbidimetry - methods</topic><topic>Immunoturbidimetry - standards</topic><topic>Iron deficiency anemia</topic><topic>Male</topic><topic>Method evaluation</topic><topic>Middle Aged</topic><topic>Receptors, Transferrin - blood</topic><topic>Reference Values</topic><topic>Soluble transferrin receptor</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bohn, Mary Kathryn</creatorcontrib><creatorcontrib>Berman, Marvin</creatorcontrib><creatorcontrib>Ali, Salman</creatorcontrib><creatorcontrib>Cheng, Pow Lee</creatorcontrib><creatorcontrib>Wang, Xiao Yan</creatorcontrib><creatorcontrib>Schneider, Randal J.</creatorcontrib><creatorcontrib>Kulasingam, Vathany</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>Clinical biochemistry</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bohn, Mary Kathryn</au><au>Berman, Marvin</au><au>Ali, Salman</au><au>Cheng, Pow Lee</au><au>Wang, Xiao Yan</au><au>Schneider, Randal J.</au><au>Kulasingam, Vathany</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of a new soluble transferrin receptor assay and comparison to three measurement procedures</atitle><jtitle>Clinical biochemistry</jtitle><addtitle>Clin Biochem</addtitle><date>2025-01</date><risdate>2025</risdate><volume>135</volume><spage>110862</spage><pages>110862-</pages><artnum>110862</artnum><issn>0009-9120</issn><issn>1873-2933</issn><eissn>1873-2933</eissn><abstract>•A new soluble transferrin receptor (sTfR) immunoturbidimetric assay was evaluated.•Comparisons to three measurement procedures demonstrated high correlation (r > 0.975).•Variable analytical bias was observed ranging from 0.44 to 1.24 mg/L.•Agreement in interpretation was moderate ranging from 74.2 to 80.5%.•Findings underline need for method-specific consideration of sTfR measurement and interpretation.
Soluble transferrin receptor (sTfR) is a useful marker in the differentiation of anemia. Clinical utility is limited by lack of standardization between measurement procedures and interpretative recommendations. Our objective was to evaluate the analytical performance of a research sTfR immunoturbidimetric assay (Alinity c, Abbott Diagnostics) and compare it to three established measurement procedures.
Assay imprecision was assessed with 7 panels across the analytical measuring interval. 159 patient samples were measured across four instrument systems (Alinity c [Abbott Diagnostics], Tina-quant c502 [Roche Diagnostics], Quantex Biokit [Werfen], and ACCESS [Beckman Coulter]). Ferritin was also measured to calculate an sTfR/Log Ferritin ratio. Sera from 100 reference individuals were assayed for sTfR and ferritin (Alinity) for reference interval (RI) verification (sTfR) or establishment (sTfR index).
Assay imprecision met defined goals. Method comparison between Alinity c and ACCESS sTfR assays showed good agreement (slope: 1.06, intercept: −0.12, r: 0.989). Comparisons across other assays demonstrated significant proportional bias with slopes ranging from 0.44 (Tina-quant c502, mean bias: −2.52 mg/L) to 1.24 (Quantex Biokit, mean bias: 0.60 mg/L). A proportional bias was observed between other instruments. While the sTfR RI was verified on the Alinity assay, agreement in interpretation (within vs outside RI) between Alinity and other platforms ranged from 74.2 to 80.5 %.
We report the first characterization of the performance of a research sTfR immunoturbidimetric assay (Alinity c, Abbott Diagnostics). Our findings emphasize the lack of harmonization between measurement procedures and result interpretation for sTfR and sTfR index, necessitating standardization efforts and clinical studies.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>39653307</pmid><doi>10.1016/j.clinbiochem.2024.110862</doi></addata></record> |
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| subjects | Adult Aged Anemia - blood Anemia - diagnosis Biomarkers - blood Female Ferritin Ferritins - blood Humans Immunoturbidimetry - methods Immunoturbidimetry - standards Iron deficiency anemia Male Method evaluation Middle Aged Receptors, Transferrin - blood Reference Values Soluble transferrin receptor |
| title | Evaluation of a new soluble transferrin receptor assay and comparison to three measurement procedures |
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