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Quality assessment and harmonization of laboratories across Europe for multiple SARS‐CoV‐2 serology assays
Background and Objectives There is a need for conversion of SARS‐CoV‐2 serology data from different laboratories to a harmonized international unit. We aimed to compare the performance of multiple SARS‐CoV‐2 antibody serology assays among 25 laboratories across 12 European countries. Materials and M...
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| Published in: | Vox sanguinis 2023-08, Vol.118 (8), p.666-673 |
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| Main Authors: | , , , , , , , |
| Format: | Article |
| Language: | English |
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| cited_by | cdi_FETCH-LOGICAL-c3530-291e71fd5eefdbcd19e77d33c51fc1c204fecc455cda2f753f58ff5e3a689d0b3 |
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| container_end_page | 673 |
| container_issue | 8 |
| container_start_page | 666 |
| container_title | Vox sanguinis |
| container_volume | 118 |
| creator | Steenhuis, Maurice Wouters, Elise Schrezenmeier, Hubert Rispens, Theo Tiberghien, Pierre Harvala, Heli Feys, Hendrik B. Schoot, C. Ellen |
| description | Background and Objectives
There is a need for conversion of SARS‐CoV‐2 serology data from different laboratories to a harmonized international unit. We aimed to compare the performance of multiple SARS‐CoV‐2 antibody serology assays among 25 laboratories across 12 European countries.
Materials and Methods
To investigate this we have distributed to all participating laboratories a panel of 15 SARS‐CoV‐2 plasma samples and a single batch of pooled plasma calibrated to the WHO IS 20/136 standard.
Results
All assays showed excellent discrimination between SARS‐CoV‐2 seronegative plasma samples and pre‐vaccinated seropositive plasma samples but differed substantially in raw antibody titres. Titres could be harmonized to binding antibody units per millilitre by calibration in relation to a reference reagent.
Conclusion
The standardization of antibody quantification is of paramount importance to allow interpretation and comparison of serology data reported in clinical trials in order to identify donor cohorts from whom the most effective convalescent plasma can be collected. |
| doi_str_mv | 10.1111/vox.13480 |
| format | article |
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There is a need for conversion of SARS‐CoV‐2 serology data from different laboratories to a harmonized international unit. We aimed to compare the performance of multiple SARS‐CoV‐2 antibody serology assays among 25 laboratories across 12 European countries.
Materials and Methods
To investigate this we have distributed to all participating laboratories a panel of 15 SARS‐CoV‐2 plasma samples and a single batch of pooled plasma calibrated to the WHO IS 20/136 standard.
Results
All assays showed excellent discrimination between SARS‐CoV‐2 seronegative plasma samples and pre‐vaccinated seropositive plasma samples but differed substantially in raw antibody titres. Titres could be harmonized to binding antibody units per millilitre by calibration in relation to a reference reagent.
Conclusion
The standardization of antibody quantification is of paramount importance to allow interpretation and comparison of serology data reported in clinical trials in order to identify donor cohorts from whom the most effective convalescent plasma can be collected.</description><identifier>ISSN: 0042-9007</identifier><identifier>EISSN: 1423-0410</identifier><identifier>DOI: 10.1111/vox.13480</identifier><identifier>PMID: 37401414</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Antibodies ; Assaying ; Calibration ; Clinical trials ; convalescent ; conversion factor ; COVID‐19 ; harmonization ; Laboratories ; Plasma ; Quality assessment ; Quality control ; Reagents ; Serology ; Severe acute respiratory syndrome ; Severe acute respiratory syndrome coronavirus 2 ; Standardization</subject><ispartof>Vox sanguinis, 2023-08, Vol.118 (8), p.666-673</ispartof><rights>2023 International Society of Blood Transfusion.</rights><rights>Copyright Vox Sanguinis © 2023 International Society of Blood Transfusion</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3530-291e71fd5eefdbcd19e77d33c51fc1c204fecc455cda2f753f58ff5e3a689d0b3</citedby><cites>FETCH-LOGICAL-c3530-291e71fd5eefdbcd19e77d33c51fc1c204fecc455cda2f753f58ff5e3a689d0b3</cites><orcidid>0000-0003-0052-8852 ; 0000-0003-1322-5869 ; 0000-0002-9310-8322</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,778,782,27907,27908</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37401414$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Steenhuis, Maurice</creatorcontrib><creatorcontrib>Wouters, Elise</creatorcontrib><creatorcontrib>Schrezenmeier, Hubert</creatorcontrib><creatorcontrib>Rispens, Theo</creatorcontrib><creatorcontrib>Tiberghien, Pierre</creatorcontrib><creatorcontrib>Harvala, Heli</creatorcontrib><creatorcontrib>Feys, Hendrik B.</creatorcontrib><creatorcontrib>Schoot, C. Ellen</creatorcontrib><creatorcontrib>SUPPORT-E Collaborators</creatorcontrib><creatorcontrib>SUPPORT‐E Collaborators</creatorcontrib><title>Quality assessment and harmonization of laboratories across Europe for multiple SARS‐CoV‐2 serology assays</title><title>Vox sanguinis</title><addtitle>Vox Sang</addtitle><description>Background and Objectives
There is a need for conversion of SARS‐CoV‐2 serology data from different laboratories to a harmonized international unit. We aimed to compare the performance of multiple SARS‐CoV‐2 antibody serology assays among 25 laboratories across 12 European countries.
Materials and Methods
To investigate this we have distributed to all participating laboratories a panel of 15 SARS‐CoV‐2 plasma samples and a single batch of pooled plasma calibrated to the WHO IS 20/136 standard.
Results
All assays showed excellent discrimination between SARS‐CoV‐2 seronegative plasma samples and pre‐vaccinated seropositive plasma samples but differed substantially in raw antibody titres. Titres could be harmonized to binding antibody units per millilitre by calibration in relation to a reference reagent.
Conclusion
The standardization of antibody quantification is of paramount importance to allow interpretation and comparison of serology data reported in clinical trials in order to identify donor cohorts from whom the most effective convalescent plasma can be collected.</description><subject>Antibodies</subject><subject>Assaying</subject><subject>Calibration</subject><subject>Clinical trials</subject><subject>convalescent</subject><subject>conversion factor</subject><subject>COVID‐19</subject><subject>harmonization</subject><subject>Laboratories</subject><subject>Plasma</subject><subject>Quality assessment</subject><subject>Quality control</subject><subject>Reagents</subject><subject>Serology</subject><subject>Severe acute respiratory syndrome</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Standardization</subject><issn>0042-9007</issn><issn>1423-0410</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNp1kc1OGzEQx62KqoTQQ1-gssQFDgvjr-7mGEUBKkVC5SPqbeV4x2Uj7zrYu0B66iPwjH2SuglwQGIOM5effpqZPyFfGByzVCf3_vGYCVnABzJgkosMJIMdMgCQPBsB5LtkL8YlABS8UJ_IrsglMMnkgLQ_eu3qbk11jBhjg21HdVvRWx0a39a_dVf7lnpLnV74oDsfaoxUm-BjpNM--BVS6wNtetfVK4f0anx59ffP08TPU-c0YvDO_9r49Truk49Wu4ifn-eQ3JxOryfn2ezi7PtkPMuMUAIyPmKYM1spRFstTMVGmOeVEEYxa5jhIC0aI5UyleY2V8KqwlqFQn8rRhUsxJAcbr2r4O96jF3Z1NGgc7pF38eSF0IAV6kl9OANuvR9aNN2iVIMFJM5S9TRltpcHtCWq1A3OqxLBuX_EMoUQrkJIbFfn439osHqlXz5egJOtsBD7XD9vqmcX_zcKv8BLXeUhA</recordid><startdate>202308</startdate><enddate>202308</enddate><creator>Steenhuis, Maurice</creator><creator>Wouters, Elise</creator><creator>Schrezenmeier, Hubert</creator><creator>Rispens, Theo</creator><creator>Tiberghien, Pierre</creator><creator>Harvala, Heli</creator><creator>Feys, Hendrik B.</creator><creator>Schoot, C. Ellen</creator><general>Blackwell Publishing Ltd</general><general>S. Karger AG</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7T5</scope><scope>7TM</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-0052-8852</orcidid><orcidid>https://orcid.org/0000-0003-1322-5869</orcidid><orcidid>https://orcid.org/0000-0002-9310-8322</orcidid></search><sort><creationdate>202308</creationdate><title>Quality assessment and harmonization of laboratories across Europe for multiple SARS‐CoV‐2 serology assays</title><author>Steenhuis, Maurice ; Wouters, Elise ; Schrezenmeier, Hubert ; Rispens, Theo ; Tiberghien, Pierre ; Harvala, Heli ; Feys, Hendrik B. ; Schoot, C. Ellen</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3530-291e71fd5eefdbcd19e77d33c51fc1c204fecc455cda2f753f58ff5e3a689d0b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Antibodies</topic><topic>Assaying</topic><topic>Calibration</topic><topic>Clinical trials</topic><topic>convalescent</topic><topic>conversion factor</topic><topic>COVID‐19</topic><topic>harmonization</topic><topic>Laboratories</topic><topic>Plasma</topic><topic>Quality assessment</topic><topic>Quality control</topic><topic>Reagents</topic><topic>Serology</topic><topic>Severe acute respiratory syndrome</topic><topic>Severe acute respiratory syndrome coronavirus 2</topic><topic>Standardization</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Steenhuis, Maurice</creatorcontrib><creatorcontrib>Wouters, Elise</creatorcontrib><creatorcontrib>Schrezenmeier, Hubert</creatorcontrib><creatorcontrib>Rispens, Theo</creatorcontrib><creatorcontrib>Tiberghien, Pierre</creatorcontrib><creatorcontrib>Harvala, Heli</creatorcontrib><creatorcontrib>Feys, Hendrik B.</creatorcontrib><creatorcontrib>Schoot, C. Ellen</creatorcontrib><creatorcontrib>SUPPORT-E Collaborators</creatorcontrib><creatorcontrib>SUPPORT‐E Collaborators</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>MEDLINE - Academic</collection><jtitle>Vox sanguinis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Steenhuis, Maurice</au><au>Wouters, Elise</au><au>Schrezenmeier, Hubert</au><au>Rispens, Theo</au><au>Tiberghien, Pierre</au><au>Harvala, Heli</au><au>Feys, Hendrik B.</au><au>Schoot, C. Ellen</au><aucorp>SUPPORT-E Collaborators</aucorp><aucorp>SUPPORT‐E Collaborators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Quality assessment and harmonization of laboratories across Europe for multiple SARS‐CoV‐2 serology assays</atitle><jtitle>Vox sanguinis</jtitle><addtitle>Vox Sang</addtitle><date>2023-08</date><risdate>2023</risdate><volume>118</volume><issue>8</issue><spage>666</spage><epage>673</epage><pages>666-673</pages><issn>0042-9007</issn><eissn>1423-0410</eissn><abstract>Background and Objectives
There is a need for conversion of SARS‐CoV‐2 serology data from different laboratories to a harmonized international unit. We aimed to compare the performance of multiple SARS‐CoV‐2 antibody serology assays among 25 laboratories across 12 European countries.
Materials and Methods
To investigate this we have distributed to all participating laboratories a panel of 15 SARS‐CoV‐2 plasma samples and a single batch of pooled plasma calibrated to the WHO IS 20/136 standard.
Results
All assays showed excellent discrimination between SARS‐CoV‐2 seronegative plasma samples and pre‐vaccinated seropositive plasma samples but differed substantially in raw antibody titres. Titres could be harmonized to binding antibody units per millilitre by calibration in relation to a reference reagent.
Conclusion
The standardization of antibody quantification is of paramount importance to allow interpretation and comparison of serology data reported in clinical trials in order to identify donor cohorts from whom the most effective convalescent plasma can be collected.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>37401414</pmid><doi>10.1111/vox.13480</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0003-0052-8852</orcidid><orcidid>https://orcid.org/0000-0003-1322-5869</orcidid><orcidid>https://orcid.org/0000-0002-9310-8322</orcidid></addata></record> |
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| identifier | ISSN: 0042-9007 |
| ispartof | Vox sanguinis, 2023-08, Vol.118 (8), p.666-673 |
| issn | 0042-9007 1423-0410 |
| language | eng |
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| source | Wiley-Blackwell Read & Publish Collection |
| subjects | Antibodies Assaying Calibration Clinical trials convalescent conversion factor COVID‐19 harmonization Laboratories Plasma Quality assessment Quality control Reagents Serology Severe acute respiratory syndrome Severe acute respiratory syndrome coronavirus 2 Standardization |
| title | Quality assessment and harmonization of laboratories across Europe for multiple SARS‐CoV‐2 serology assays |
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