Analytical validation of a multi‐protein, serum‐based assay for disease activity assessments in multiple sclerosis
Purpose To characterize and analytically validate the MSDA Test, a multi‐protein, serum‐based biomarker assay developed using Olink® PEA methodology. Experimental design Two lots of the MSDA Test panel were manufactured and subjected to a comprehensive analytical characterization and validation prot...
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| Veröffentlicht in: | Proteomics. Clinical applications 2023-05, Vol.17 (3), p.e2200018-n/a |
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| creator | Qureshi, Ferhan Hu, Wayne Loh, Louisa Patel, Hemali DeGuzman, Maria Becich, Michael Rubio da Costa, Fatima Gehman, Victor Zhang, Fujun Foley, John Chitnis, Tanuja |
| description | Purpose
To characterize and analytically validate the MSDA Test, a multi‐protein, serum‐based biomarker assay developed using Olink® PEA methodology.
Experimental design
Two lots of the MSDA Test panel were manufactured and subjected to a comprehensive analytical characterization and validation protocol to detect biomarkers present in the serum of patients with multiple sclerosis (MS). Biomarker concentrations were incorporated into a final algorithm used for calculating four Disease Pathway scores (Immunomodulation, Neuroinflammation, Myelin Biology, and Neuroaxonal Integrity) and an overall Disease Activity score.
Results
Analytical characterization demonstrated that the multi‐protein panel satisfied the criteria necessary for a fit‐for‐purpose validation considering the assay's intended clinical use. This panel met acceptability criteria for 18 biomarkers included in the final algorithm out of 21 biomarkers evaluated. VCAN was omitted based on factors outside of analytical validation; COL4A1 and GH were excluded based on imprecision and diurnal variability, respectively. Performance of the four Disease Pathway and overall Disease Activity scores met the established acceptability criteria.
Conclusions and clinical relevance
Analytical validation of this multi‐protein, serum‐based assay is the first step in establishing its potential utility as a quantitative, minimally invasive, and scalable biomarker panel to enhance the standard of care for patients with MS. |
| doi_str_mv | 10.1002/prca.202200018 |
| format | Article |
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To characterize and analytically validate the MSDA Test, a multi‐protein, serum‐based biomarker assay developed using Olink® PEA methodology.
Experimental design
Two lots of the MSDA Test panel were manufactured and subjected to a comprehensive analytical characterization and validation protocol to detect biomarkers present in the serum of patients with multiple sclerosis (MS). Biomarker concentrations were incorporated into a final algorithm used for calculating four Disease Pathway scores (Immunomodulation, Neuroinflammation, Myelin Biology, and Neuroaxonal Integrity) and an overall Disease Activity score.
Results
Analytical characterization demonstrated that the multi‐protein panel satisfied the criteria necessary for a fit‐for‐purpose validation considering the assay's intended clinical use. This panel met acceptability criteria for 18 biomarkers included in the final algorithm out of 21 biomarkers evaluated. VCAN was omitted based on factors outside of analytical validation; COL4A1 and GH were excluded based on imprecision and diurnal variability, respectively. Performance of the four Disease Pathway and overall Disease Activity scores met the established acceptability criteria.
Conclusions and clinical relevance
Analytical validation of this multi‐protein, serum‐based assay is the first step in establishing its potential utility as a quantitative, minimally invasive, and scalable biomarker panel to enhance the standard of care for patients with MS.</description><identifier>ISSN: 1862-8346</identifier><identifier>EISSN: 1862-8354</identifier><identifier>DOI: 10.1002/prca.202200018</identifier><identifier>PMID: 36843211</identifier><language>eng</language><publisher>Germany: Wiley Subscription Services, Inc</publisher><subject>Acceptability ; Acceptance criteria ; Algorithms ; analytical characterization ; analytical validation ; Assaying ; biomarker ; Biomarkers ; Blood Proteins ; Design of experiments ; Humans ; Immunomodulation ; Inflammation ; Mathematical analysis ; Multiple Sclerosis ; Myelin ; Proteins ; proximity extension assay</subject><ispartof>Proteomics. Clinical applications, 2023-05, Vol.17 (3), p.e2200018-n/a</ispartof><rights>2023 The Authors. Proteomics – Clinical Applications published by Wiley‐VCH GmbH.</rights><rights>2023 The Authors. Proteomics - Clinical Applications published by Wiley-VCH GmbH.</rights><rights>2023. This article is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4083-acd723967f3ed5ea7983dc145df354076837dbd22d67e3afa2ff7943d7ff2a913</citedby><cites>FETCH-LOGICAL-c4083-acd723967f3ed5ea7983dc145df354076837dbd22d67e3afa2ff7943d7ff2a913</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fprca.202200018$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fprca.202200018$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36843211$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Qureshi, Ferhan</creatorcontrib><creatorcontrib>Hu, Wayne</creatorcontrib><creatorcontrib>Loh, Louisa</creatorcontrib><creatorcontrib>Patel, Hemali</creatorcontrib><creatorcontrib>DeGuzman, Maria</creatorcontrib><creatorcontrib>Becich, Michael</creatorcontrib><creatorcontrib>Rubio da Costa, Fatima</creatorcontrib><creatorcontrib>Gehman, Victor</creatorcontrib><creatorcontrib>Zhang, Fujun</creatorcontrib><creatorcontrib>Foley, John</creatorcontrib><creatorcontrib>Chitnis, Tanuja</creatorcontrib><title>Analytical validation of a multi‐protein, serum‐based assay for disease activity assessments in multiple sclerosis</title><title>Proteomics. Clinical applications</title><addtitle>Proteomics Clin Appl</addtitle><description>Purpose
To characterize and analytically validate the MSDA Test, a multi‐protein, serum‐based biomarker assay developed using Olink® PEA methodology.
Experimental design
Two lots of the MSDA Test panel were manufactured and subjected to a comprehensive analytical characterization and validation protocol to detect biomarkers present in the serum of patients with multiple sclerosis (MS). Biomarker concentrations were incorporated into a final algorithm used for calculating four Disease Pathway scores (Immunomodulation, Neuroinflammation, Myelin Biology, and Neuroaxonal Integrity) and an overall Disease Activity score.
Results
Analytical characterization demonstrated that the multi‐protein panel satisfied the criteria necessary for a fit‐for‐purpose validation considering the assay's intended clinical use. This panel met acceptability criteria for 18 biomarkers included in the final algorithm out of 21 biomarkers evaluated. VCAN was omitted based on factors outside of analytical validation; COL4A1 and GH were excluded based on imprecision and diurnal variability, respectively. Performance of the four Disease Pathway and overall Disease Activity scores met the established acceptability criteria.
Conclusions and clinical relevance
Analytical validation of this multi‐protein, serum‐based assay is the first step in establishing its potential utility as a quantitative, minimally invasive, and scalable biomarker panel to enhance the standard of care for patients with MS.</description><subject>Acceptability</subject><subject>Acceptance criteria</subject><subject>Algorithms</subject><subject>analytical characterization</subject><subject>analytical validation</subject><subject>Assaying</subject><subject>biomarker</subject><subject>Biomarkers</subject><subject>Blood Proteins</subject><subject>Design of experiments</subject><subject>Humans</subject><subject>Immunomodulation</subject><subject>Inflammation</subject><subject>Mathematical analysis</subject><subject>Multiple Sclerosis</subject><subject>Myelin</subject><subject>Proteins</subject><subject>proximity extension assay</subject><issn>1862-8346</issn><issn>1862-8354</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNqFkU2L1EAQhhtxcdfVq0dp8OLBGfsr6c5xGPyChRXRc6jproZeOsmYSkZy8yf4G_0l28Osc_CypyqqnnrhrZexV1KspRDq_X70sFZCKSGEdE_YlXS1Wjldmafn3tSX7DnRnRCVUVY8Y5e6dkYrKa_YYdNDXqbkIfMD5BRgSkPPh8iBd3Oe0t_ff_bjMGHq33HCce7KYAeEgQMRLDwOIw-JsIw4-Ckd0rQcV0jUYT8RT_1JaJ-Rk884DpToBbuIkAlfPtRr9uPjh-_bz6ub209ftpublTfC6RX4YJVuahs1hgrBNk4HL00VYnEobO20DbugVKgtaoigYrSN0cHGqKCR-pq9PekWDz9npKntEnnMGXocZmqVdcI42Zgj-uY_9G6Yx_KdQjmpnWkqZQu1PlG--KARY7sfUwfj0krRHhNpj4m050TKwesH2XnXYTjj_yIogDkBv1LG5RG59uu37UapSut7INOasg</recordid><startdate>202305</startdate><enddate>202305</enddate><creator>Qureshi, Ferhan</creator><creator>Hu, Wayne</creator><creator>Loh, Louisa</creator><creator>Patel, Hemali</creator><creator>DeGuzman, Maria</creator><creator>Becich, Michael</creator><creator>Rubio da Costa, Fatima</creator><creator>Gehman, Victor</creator><creator>Zhang, Fujun</creator><creator>Foley, John</creator><creator>Chitnis, Tanuja</creator><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>WIN</scope><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>7T5</scope><scope>7TK</scope><scope>7TM</scope><scope>7TO</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope></search><sort><creationdate>202305</creationdate><title>Analytical validation of a multi‐protein, serum‐based assay for disease activity assessments in multiple sclerosis</title><author>Qureshi, Ferhan ; Hu, Wayne ; Loh, Louisa ; Patel, Hemali ; DeGuzman, Maria ; Becich, Michael ; Rubio da Costa, Fatima ; Gehman, Victor ; Zhang, Fujun ; Foley, John ; Chitnis, Tanuja</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4083-acd723967f3ed5ea7983dc145df354076837dbd22d67e3afa2ff7943d7ff2a913</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Acceptability</topic><topic>Acceptance criteria</topic><topic>Algorithms</topic><topic>analytical characterization</topic><topic>analytical validation</topic><topic>Assaying</topic><topic>biomarker</topic><topic>Biomarkers</topic><topic>Blood Proteins</topic><topic>Design of experiments</topic><topic>Humans</topic><topic>Immunomodulation</topic><topic>Inflammation</topic><topic>Mathematical analysis</topic><topic>Multiple Sclerosis</topic><topic>Myelin</topic><topic>Proteins</topic><topic>proximity extension assay</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Qureshi, Ferhan</creatorcontrib><creatorcontrib>Hu, Wayne</creatorcontrib><creatorcontrib>Loh, Louisa</creatorcontrib><creatorcontrib>Patel, Hemali</creatorcontrib><creatorcontrib>DeGuzman, Maria</creatorcontrib><creatorcontrib>Becich, Michael</creatorcontrib><creatorcontrib>Rubio da Costa, Fatima</creatorcontrib><creatorcontrib>Gehman, Victor</creatorcontrib><creatorcontrib>Zhang, Fujun</creatorcontrib><creatorcontrib>Foley, John</creatorcontrib><creatorcontrib>Chitnis, Tanuja</creatorcontrib><collection>Wiley Online Library (Open Access Collection)</collection><collection>Wiley Online Library Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Proteomics. Clinical applications</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Qureshi, Ferhan</au><au>Hu, Wayne</au><au>Loh, Louisa</au><au>Patel, Hemali</au><au>DeGuzman, Maria</au><au>Becich, Michael</au><au>Rubio da Costa, Fatima</au><au>Gehman, Victor</au><au>Zhang, Fujun</au><au>Foley, John</au><au>Chitnis, Tanuja</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Analytical validation of a multi‐protein, serum‐based assay for disease activity assessments in multiple sclerosis</atitle><jtitle>Proteomics. Clinical applications</jtitle><addtitle>Proteomics Clin Appl</addtitle><date>2023-05</date><risdate>2023</risdate><volume>17</volume><issue>3</issue><spage>e2200018</spage><epage>n/a</epage><pages>e2200018-n/a</pages><issn>1862-8346</issn><eissn>1862-8354</eissn><abstract>Purpose
To characterize and analytically validate the MSDA Test, a multi‐protein, serum‐based biomarker assay developed using Olink® PEA methodology.
Experimental design
Two lots of the MSDA Test panel were manufactured and subjected to a comprehensive analytical characterization and validation protocol to detect biomarkers present in the serum of patients with multiple sclerosis (MS). Biomarker concentrations were incorporated into a final algorithm used for calculating four Disease Pathway scores (Immunomodulation, Neuroinflammation, Myelin Biology, and Neuroaxonal Integrity) and an overall Disease Activity score.
Results
Analytical characterization demonstrated that the multi‐protein panel satisfied the criteria necessary for a fit‐for‐purpose validation considering the assay's intended clinical use. This panel met acceptability criteria for 18 biomarkers included in the final algorithm out of 21 biomarkers evaluated. VCAN was omitted based on factors outside of analytical validation; COL4A1 and GH were excluded based on imprecision and diurnal variability, respectively. Performance of the four Disease Pathway and overall Disease Activity scores met the established acceptability criteria.
Conclusions and clinical relevance
Analytical validation of this multi‐protein, serum‐based assay is the first step in establishing its potential utility as a quantitative, minimally invasive, and scalable biomarker panel to enhance the standard of care for patients with MS.</abstract><cop>Germany</cop><pub>Wiley Subscription Services, Inc</pub><pmid>36843211</pmid><doi>10.1002/prca.202200018</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1862-8346 |
| ispartof | Proteomics. Clinical applications, 2023-05, Vol.17 (3), p.e2200018-n/a |
| issn | 1862-8346 1862-8354 |
| language | eng |
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| source | MEDLINE; Access via Wiley Online Library |
| subjects | Acceptability Acceptance criteria Algorithms analytical characterization analytical validation Assaying biomarker Biomarkers Blood Proteins Design of experiments Humans Immunomodulation Inflammation Mathematical analysis Multiple Sclerosis Myelin Proteins proximity extension assay |
| title | Analytical validation of a multi‐protein, serum‐based assay for disease activity assessments in multiple sclerosis |
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