BAY 81-8973, a full-length recombinant factor VIII: results from an International comparative laboratory field study
Introduction BAY 81‐8973 is a full‐length, unmodified, recombinant human factor VIII (FVIII) with the same primary amino acid sequence as sucrose‐formulated recombinant FVIII but produced with certain more advanced manufacturing technologies. Aim This global laboratory study evaluated variability in...
Gespeichert in:
| Veröffentlicht in: | Haemophilia : the official journal of the World Federation of Hemophilia 2016-05, Vol.22 (3), p.e192-e199 |
|---|---|
| Hauptverfasser: | , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | e199 |
|---|---|
| container_issue | 3 |
| container_start_page | e192 |
| container_title | Haemophilia : the official journal of the World Federation of Hemophilia |
| container_volume | 22 |
| creator | Kitchen, S. Beckmann, H. Katterle, Y. Bruns, S. Tseneklidou-Stoeter, D. Maas Enriquez, M. |
| description | Introduction
BAY 81‐8973 is a full‐length, unmodified, recombinant human factor VIII (FVIII) with the same primary amino acid sequence as sucrose‐formulated recombinant FVIII but produced with certain more advanced manufacturing technologies.
Aim
This global laboratory study evaluated variability in measurement of BAY 81‐8973 using one‐stage and chromogenic assays compared with antihaemophilic factor (recombinant) plasma/albumin‐free method (rAHF‐PFM; Advate®) under assay conditions routinely used in clinical laboratories.
Methods
BAY 81‐8973 or rAHF‐PFM was spiked into FVIII‐deficient plasma at 0.043 (low), 0.375 (medium) and 0.865 (normal) IU mL−1. Participating laboratories analysed blinded samples and normal plasma in triplicate using their routine assay, reagents and standards. Results were analysed for intra‐ and interlaboratory variability.
Results
Forty‐one laboratories in 11 countries participated in the study. One‐stage assay and chromogenic assays were used by 40 and 10 laboratories, respectively; 9 laboratories used both assays. Intralaboratory variability was |
| doi_str_mv | 10.1111/hae.12925 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1808673611</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2509243258</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4595-b9bfdee1a63528f8bc9b7a5466eb6f389fdb028a22de614e0d3face224cdd0013</originalsourceid><addsrcrecordid>eNqNkUtv1DAUhS0Eog9Y8AeQJTYgkdaP2EnYzYxKJ1IFSLwEG8tOrmmKEw-2U5h_j4dpu0BCwhtfy985ukcHoSeUnNB8Ti81nFDWMHEPHVIuRcEElfd3s6BFzag8QEcxXhFCOSPyITpgFeGEVvwQpeXiC64z1VT8JdbYzs4VDqZv6RIH6PxohklPCVvdJR_wp7ZtX-WPOLsUsQ1-xHrC7ZQgTDoNftIOZ9FGh_y6Buy08Xn0YYvtAK7HMc399hF6YLWL8PjmPkYfX599WK2Li7fn7WpxUXSlaERhGmN7AKolF6y2tekaU2lRSglGWl43tjeE1ZqxHiQtgfQ8rwmMlV3f78Ieo-d7303wP2aISY1D7MA5PYGfo6I1qWXFJf0PtGpIKUoqSEaf_YVe-TnHd1ExQRpWcibqTL3YU13wMQawahOGUYetokTtWlO5NfWntcw-vXGczQj9HXlbUwZO98DPwcH2305qvTi7tSz2iiEm-HWn0OG7yokroT6_OVdLsl4tv75_p9b8NwiursQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2509243258</pqid></control><display><type>article</type><title>BAY 81-8973, a full-length recombinant factor VIII: results from an International comparative laboratory field study</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Kitchen, S. ; Beckmann, H. ; Katterle, Y. ; Bruns, S. ; Tseneklidou-Stoeter, D. ; Maas Enriquez, M.</creator><creatorcontrib>Kitchen, S. ; Beckmann, H. ; Katterle, Y. ; Bruns, S. ; Tseneklidou-Stoeter, D. ; Maas Enriquez, M.</creatorcontrib><description>Introduction
BAY 81‐8973 is a full‐length, unmodified, recombinant human factor VIII (FVIII) with the same primary amino acid sequence as sucrose‐formulated recombinant FVIII but produced with certain more advanced manufacturing technologies.
Aim
This global laboratory study evaluated variability in measurement of BAY 81‐8973 using one‐stage and chromogenic assays compared with antihaemophilic factor (recombinant) plasma/albumin‐free method (rAHF‐PFM; Advate®) under assay conditions routinely used in clinical laboratories.
Methods
BAY 81‐8973 or rAHF‐PFM was spiked into FVIII‐deficient plasma at 0.043 (low), 0.375 (medium) and 0.865 (normal) IU mL−1. Participating laboratories analysed blinded samples and normal plasma in triplicate using their routine assay, reagents and standards. Results were analysed for intra‐ and interlaboratory variability.
Results
Forty‐one laboratories in 11 countries participated in the study. One‐stage assay and chromogenic assays were used by 40 and 10 laboratories, respectively; 9 laboratories used both assays. Intralaboratory variability was <11% for both assays and both products at all concentrations. Interlaboratory variability was highest at the low concentration in the chromogenic and one‐stage assay for BAY 81‐8973 (60.0% and 33.7%, respectively) and rAHF‐PFM (51.0% and 30.8%) and was lowest at the normal concentration (BAY 81‐8973, 5.4% and 14.0%; rAHF‐PFM, 5.8% and 12.4%), which was similar to the plasma control (6.6% and 10.3%). The chromogenic:one‐stage assay ratio ranged from 0.95 (low concentration) to 1.10 (normal concentration) for BAY 81‐8973 and 0.96–1.18 for rAHF‐PFM.
Conclusions
BAY 81‐8973 can be accurately measured in plasma using the one‐stage and chromogenic assays routinely used in clinical laboratories without a product‐specific standard.</description><identifier>ISSN: 1351-8216</identifier><identifier>EISSN: 1365-2516</identifier><identifier>DOI: 10.1111/hae.12925</identifier><identifier>PMID: 27030173</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Advanced manufacturing technologies ; Amino acid sequence ; chromogenic assay ; Coagulation factors ; factor VIII ; Factor VIII - analysis ; Factor VIII - therapeutic use ; field study ; Hemophilia A - drug therapy ; Humans ; International Cooperation ; Laboratories ; Medical laboratories ; Observer Variation ; one-stage assay ; Pharmaceutical Preparations - analysis ; Plasma ; Plasma - chemistry ; postinfusion monitoring ; recombinant factor VIII ; Recombinant Proteins - analysis ; Recombinant Proteins - therapeutic use ; Sucrose</subject><ispartof>Haemophilia : the official journal of the World Federation of Hemophilia, 2016-05, Vol.22 (3), p.e192-e199</ispartof><rights>2016 The Authors. Published by John Wiley & Sons Ltd.</rights><rights>2016 The Authors. Haemophilia Published by John Wiley & Sons Ltd.</rights><rights>2016. This article is published under http://creativecommons.org/licenses/by-nc/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-c4595-b9bfdee1a63528f8bc9b7a5466eb6f389fdb028a22de614e0d3face224cdd0013</citedby><cites>FETCH-LOGICAL-c4595-b9bfdee1a63528f8bc9b7a5466eb6f389fdb028a22de614e0d3face224cdd0013</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fhae.12925$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fhae.12925$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,777,781,1412,27905,27906,45555,45556</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27030173$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kitchen, S.</creatorcontrib><creatorcontrib>Beckmann, H.</creatorcontrib><creatorcontrib>Katterle, Y.</creatorcontrib><creatorcontrib>Bruns, S.</creatorcontrib><creatorcontrib>Tseneklidou-Stoeter, D.</creatorcontrib><creatorcontrib>Maas Enriquez, M.</creatorcontrib><title>BAY 81-8973, a full-length recombinant factor VIII: results from an International comparative laboratory field study</title><title>Haemophilia : the official journal of the World Federation of Hemophilia</title><addtitle>Haemophilia</addtitle><description>Introduction
BAY 81‐8973 is a full‐length, unmodified, recombinant human factor VIII (FVIII) with the same primary amino acid sequence as sucrose‐formulated recombinant FVIII but produced with certain more advanced manufacturing technologies.
Aim
This global laboratory study evaluated variability in measurement of BAY 81‐8973 using one‐stage and chromogenic assays compared with antihaemophilic factor (recombinant) plasma/albumin‐free method (rAHF‐PFM; Advate®) under assay conditions routinely used in clinical laboratories.
Methods
BAY 81‐8973 or rAHF‐PFM was spiked into FVIII‐deficient plasma at 0.043 (low), 0.375 (medium) and 0.865 (normal) IU mL−1. Participating laboratories analysed blinded samples and normal plasma in triplicate using their routine assay, reagents and standards. Results were analysed for intra‐ and interlaboratory variability.
Results
Forty‐one laboratories in 11 countries participated in the study. One‐stage assay and chromogenic assays were used by 40 and 10 laboratories, respectively; 9 laboratories used both assays. Intralaboratory variability was <11% for both assays and both products at all concentrations. Interlaboratory variability was highest at the low concentration in the chromogenic and one‐stage assay for BAY 81‐8973 (60.0% and 33.7%, respectively) and rAHF‐PFM (51.0% and 30.8%) and was lowest at the normal concentration (BAY 81‐8973, 5.4% and 14.0%; rAHF‐PFM, 5.8% and 12.4%), which was similar to the plasma control (6.6% and 10.3%). The chromogenic:one‐stage assay ratio ranged from 0.95 (low concentration) to 1.10 (normal concentration) for BAY 81‐8973 and 0.96–1.18 for rAHF‐PFM.
Conclusions
BAY 81‐8973 can be accurately measured in plasma using the one‐stage and chromogenic assays routinely used in clinical laboratories without a product‐specific standard.</description><subject>Advanced manufacturing technologies</subject><subject>Amino acid sequence</subject><subject>chromogenic assay</subject><subject>Coagulation factors</subject><subject>factor VIII</subject><subject>Factor VIII - analysis</subject><subject>Factor VIII - therapeutic use</subject><subject>field study</subject><subject>Hemophilia A - drug therapy</subject><subject>Humans</subject><subject>International Cooperation</subject><subject>Laboratories</subject><subject>Medical laboratories</subject><subject>Observer Variation</subject><subject>one-stage assay</subject><subject>Pharmaceutical Preparations - analysis</subject><subject>Plasma</subject><subject>Plasma - chemistry</subject><subject>postinfusion monitoring</subject><subject>recombinant factor VIII</subject><subject>Recombinant Proteins - analysis</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Sucrose</subject><issn>1351-8216</issn><issn>1365-2516</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNqNkUtv1DAUhS0Eog9Y8AeQJTYgkdaP2EnYzYxKJ1IFSLwEG8tOrmmKEw-2U5h_j4dpu0BCwhtfy985ukcHoSeUnNB8Ti81nFDWMHEPHVIuRcEElfd3s6BFzag8QEcxXhFCOSPyITpgFeGEVvwQpeXiC64z1VT8JdbYzs4VDqZv6RIH6PxohklPCVvdJR_wp7ZtX-WPOLsUsQ1-xHrC7ZQgTDoNftIOZ9FGh_y6Buy08Xn0YYvtAK7HMc399hF6YLWL8PjmPkYfX599WK2Li7fn7WpxUXSlaERhGmN7AKolF6y2tekaU2lRSglGWl43tjeE1ZqxHiQtgfQ8rwmMlV3f78Ieo-d7303wP2aISY1D7MA5PYGfo6I1qWXFJf0PtGpIKUoqSEaf_YVe-TnHd1ExQRpWcibqTL3YU13wMQawahOGUYetokTtWlO5NfWntcw-vXGczQj9HXlbUwZO98DPwcH2305qvTi7tSz2iiEm-HWn0OG7yokroT6_OVdLsl4tv75_p9b8NwiursQ</recordid><startdate>201605</startdate><enddate>201605</enddate><creator>Kitchen, S.</creator><creator>Beckmann, H.</creator><creator>Katterle, Y.</creator><creator>Bruns, S.</creator><creator>Tseneklidou-Stoeter, D.</creator><creator>Maas Enriquez, M.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><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>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope></search><sort><creationdate>201605</creationdate><title>BAY 81-8973, a full-length recombinant factor VIII: results from an International comparative laboratory field study</title><author>Kitchen, S. ; Beckmann, H. ; Katterle, Y. ; Bruns, S. ; Tseneklidou-Stoeter, D. ; Maas Enriquez, M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4595-b9bfdee1a63528f8bc9b7a5466eb6f389fdb028a22de614e0d3face224cdd0013</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Advanced manufacturing technologies</topic><topic>Amino acid sequence</topic><topic>chromogenic assay</topic><topic>Coagulation factors</topic><topic>factor VIII</topic><topic>Factor VIII - analysis</topic><topic>Factor VIII - therapeutic use</topic><topic>field study</topic><topic>Hemophilia A - drug therapy</topic><topic>Humans</topic><topic>International Cooperation</topic><topic>Laboratories</topic><topic>Medical laboratories</topic><topic>Observer Variation</topic><topic>one-stage assay</topic><topic>Pharmaceutical Preparations - analysis</topic><topic>Plasma</topic><topic>Plasma - chemistry</topic><topic>postinfusion monitoring</topic><topic>recombinant factor VIII</topic><topic>Recombinant Proteins - analysis</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Sucrose</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kitchen, S.</creatorcontrib><creatorcontrib>Beckmann, H.</creatorcontrib><creatorcontrib>Katterle, Y.</creatorcontrib><creatorcontrib>Bruns, S.</creatorcontrib><creatorcontrib>Tseneklidou-Stoeter, D.</creatorcontrib><creatorcontrib>Maas Enriquez, M.</creatorcontrib><collection>Istex</collection><collection>Wiley Online Library Open Access</collection><collection>Wiley 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>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Haemophilia : the official journal of the World Federation of Hemophilia</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kitchen, S.</au><au>Beckmann, H.</au><au>Katterle, Y.</au><au>Bruns, S.</au><au>Tseneklidou-Stoeter, D.</au><au>Maas Enriquez, M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>BAY 81-8973, a full-length recombinant factor VIII: results from an International comparative laboratory field study</atitle><jtitle>Haemophilia : the official journal of the World Federation of Hemophilia</jtitle><addtitle>Haemophilia</addtitle><date>2016-05</date><risdate>2016</risdate><volume>22</volume><issue>3</issue><spage>e192</spage><epage>e199</epage><pages>e192-e199</pages><issn>1351-8216</issn><eissn>1365-2516</eissn><abstract>Introduction
BAY 81‐8973 is a full‐length, unmodified, recombinant human factor VIII (FVIII) with the same primary amino acid sequence as sucrose‐formulated recombinant FVIII but produced with certain more advanced manufacturing technologies.
Aim
This global laboratory study evaluated variability in measurement of BAY 81‐8973 using one‐stage and chromogenic assays compared with antihaemophilic factor (recombinant) plasma/albumin‐free method (rAHF‐PFM; Advate®) under assay conditions routinely used in clinical laboratories.
Methods
BAY 81‐8973 or rAHF‐PFM was spiked into FVIII‐deficient plasma at 0.043 (low), 0.375 (medium) and 0.865 (normal) IU mL−1. Participating laboratories analysed blinded samples and normal plasma in triplicate using their routine assay, reagents and standards. Results were analysed for intra‐ and interlaboratory variability.
Results
Forty‐one laboratories in 11 countries participated in the study. One‐stage assay and chromogenic assays were used by 40 and 10 laboratories, respectively; 9 laboratories used both assays. Intralaboratory variability was <11% for both assays and both products at all concentrations. Interlaboratory variability was highest at the low concentration in the chromogenic and one‐stage assay for BAY 81‐8973 (60.0% and 33.7%, respectively) and rAHF‐PFM (51.0% and 30.8%) and was lowest at the normal concentration (BAY 81‐8973, 5.4% and 14.0%; rAHF‐PFM, 5.8% and 12.4%), which was similar to the plasma control (6.6% and 10.3%). The chromogenic:one‐stage assay ratio ranged from 0.95 (low concentration) to 1.10 (normal concentration) for BAY 81‐8973 and 0.96–1.18 for rAHF‐PFM.
Conclusions
BAY 81‐8973 can be accurately measured in plasma using the one‐stage and chromogenic assays routinely used in clinical laboratories without a product‐specific standard.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>27030173</pmid><doi>10.1111/hae.12925</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1351-8216 |
| ispartof | Haemophilia : the official journal of the World Federation of Hemophilia, 2016-05, Vol.22 (3), p.e192-e199 |
| issn | 1351-8216 1365-2516 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1808673611 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Advanced manufacturing technologies Amino acid sequence chromogenic assay Coagulation factors factor VIII Factor VIII - analysis Factor VIII - therapeutic use field study Hemophilia A - drug therapy Humans International Cooperation Laboratories Medical laboratories Observer Variation one-stage assay Pharmaceutical Preparations - analysis Plasma Plasma - chemistry postinfusion monitoring recombinant factor VIII Recombinant Proteins - analysis Recombinant Proteins - therapeutic use Sucrose |
| title | BAY 81-8973, a full-length recombinant factor VIII: results from an International comparative laboratory field study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-19T01%3A44%3A49IST&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=BAY%2081-8973,%20a%20full-length%20recombinant%20factor%20VIII:%20results%20from%20an%20International%20comparative%20laboratory%20field%20study&rft.jtitle=Haemophilia%20:%20the%20official%20journal%20of%20the%20World%20Federation%20of%20Hemophilia&rft.au=Kitchen,%20S.&rft.date=2016-05&rft.volume=22&rft.issue=3&rft.spage=e192&rft.epage=e199&rft.pages=e192-e199&rft.issn=1351-8216&rft.eissn=1365-2516&rft_id=info:doi/10.1111/hae.12925&rft_dat=%3Cproquest_cross%3E2509243258%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=2509243258&rft_id=info:pmid/27030173&rfr_iscdi=true |