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Thrombin generation assay using factor IXa as a trigger to quantify accurately factor VIII levels in haemophilia A
Background: The available methods for measuring factor VIII (FVIII) activity suffer reportedly from lack of sensitivity and precision in the
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| Published in: | Journal of thrombosis and haemostasis 2011-08, Vol.9 (8), p.1549-1555 |
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| Main Authors: | , , , , , |
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| cites | cdi_FETCH-LOGICAL-c4188-ff77597a36aca220bedbc182577fdf3cc8c915ab04fdd31bf8d8138a9392d6fc3 |
| container_end_page | 1555 |
| container_issue | 8 |
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| container_title | Journal of thrombosis and haemostasis |
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| creator | NINIVAGGI, M. DARGAUD, Y. Van OERLE, R. De LAAT, B. HEMKER, H. C. LINDHOUT, T. |
| description | Background: The available methods for measuring factor VIII (FVIII) activity suffer reportedly from lack of sensitivity and precision in the |
| doi_str_mv | 10.1111/j.1538-7836.2011.04358.x |
| format | article |
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C. ; LINDHOUT, T.</creator><creatorcontrib>NINIVAGGI, M. ; DARGAUD, Y. ; Van OERLE, R. ; De LAAT, B. ; HEMKER, H. C. ; LINDHOUT, T.</creatorcontrib><description>Background: The available methods for measuring factor VIII (FVIII) activity suffer reportedly from lack of sensitivity and precision in the < 1 IU dL−1 range. This precludes correlation of clinical phenotype with FVIII levels. Objectives: To study a possible association between clinical phenotype in patients with FVIII levels < 1 IU dL−1. Methods/Results: The FIXa‐driven FVIII assay (FVIII‐CAT) has a detection limit of 0.05 IU dL−1. For the range of 0–2 IU dL−1 FVIII, the intra‐assay coefficient of variation (CV) is around 2% and the inter‐assay CV is about 8%. We tested 30 hemophiliacs with FVIII:C between < 1 and 6 IU dL−1 as measured in the one‐stage clotting assay using the FVIII‐CAT assay. For genetic defects related to moderate hemophilia, the FVIII‐CAT test finds FVIII levels that are in good agreement with those determined with the one‐stage assay. Of the 21 hemophilic patients with FVIII < 1 IU dL−1, four patients exhibited a mild bleeding phenotype. When we applied TF‐initiated thrombin generation, patients with a mild clinical phenotype showed significantly higher endogenous thrombin potentials. Conclusion: The novel developed FVIII assay measures accurately FVIII levels below 1 IU dL−1. Its application demonstrated that the clinical heterogeneity in individuals with < 1 IU dL−1 FVIII is not associated with their FVIII level.</description><identifier>ISSN: 1538-7933</identifier><identifier>ISSN: 1538-7836</identifier><identifier>EISSN: 1538-7836</identifier><identifier>DOI: 10.1111/j.1538-7836.2011.04358.x</identifier><identifier>PMID: 21605333</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Biomarkers - blood ; Blood Coagulation Tests ; factor IXa‐driven thrombin generation ; Factor VIII - analysis ; Factor Xa - metabolism ; France ; FVIII‐assay ; hemophilia A ; Hemophilia A - blood ; Hemophilia A - diagnosis ; Humans ; Kinetics ; Middle Aged ; Netherlands ; Phenotype ; Predictive Value of Tests ; Reproducibility of Results ; Sensitivity and Specificity ; Severity of Illness Index ; Thrombin - metabolism ; Thromboplastin - metabolism ; Young Adult</subject><ispartof>Journal of thrombosis and haemostasis, 2011-08, Vol.9 (8), p.1549-1555</ispartof><rights>2011 International Society on Thrombosis and Haemostasis</rights><rights>2011 International Society on Thrombosis and Haemostasis.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4188-ff77597a36aca220bedbc182577fdf3cc8c915ab04fdd31bf8d8138a9392d6fc3</citedby><cites>FETCH-LOGICAL-c4188-ff77597a36aca220bedbc182577fdf3cc8c915ab04fdd31bf8d8138a9392d6fc3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21605333$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>NINIVAGGI, M.</creatorcontrib><creatorcontrib>DARGAUD, Y.</creatorcontrib><creatorcontrib>Van OERLE, R.</creatorcontrib><creatorcontrib>De LAAT, B.</creatorcontrib><creatorcontrib>HEMKER, H. C.</creatorcontrib><creatorcontrib>LINDHOUT, T.</creatorcontrib><title>Thrombin generation assay using factor IXa as a trigger to quantify accurately factor VIII levels in haemophilia A</title><title>Journal of thrombosis and haemostasis</title><addtitle>J Thromb Haemost</addtitle><description>Background: The available methods for measuring factor VIII (FVIII) activity suffer reportedly from lack of sensitivity and precision in the < 1 IU dL−1 range. This precludes correlation of clinical phenotype with FVIII levels. Objectives: To study a possible association between clinical phenotype in patients with FVIII levels < 1 IU dL−1. Methods/Results: The FIXa‐driven FVIII assay (FVIII‐CAT) has a detection limit of 0.05 IU dL−1. For the range of 0–2 IU dL−1 FVIII, the intra‐assay coefficient of variation (CV) is around 2% and the inter‐assay CV is about 8%. We tested 30 hemophiliacs with FVIII:C between < 1 and 6 IU dL−1 as measured in the one‐stage clotting assay using the FVIII‐CAT assay. For genetic defects related to moderate hemophilia, the FVIII‐CAT test finds FVIII levels that are in good agreement with those determined with the one‐stage assay. Of the 21 hemophilic patients with FVIII < 1 IU dL−1, four patients exhibited a mild bleeding phenotype. When we applied TF‐initiated thrombin generation, patients with a mild clinical phenotype showed significantly higher endogenous thrombin potentials. Conclusion: The novel developed FVIII assay measures accurately FVIII levels below 1 IU dL−1. Its application demonstrated that the clinical heterogeneity in individuals with < 1 IU dL−1 FVIII is not associated with their FVIII level.</description><subject>Adult</subject><subject>Aged</subject><subject>Biomarkers - blood</subject><subject>Blood Coagulation Tests</subject><subject>factor IXa‐driven thrombin generation</subject><subject>Factor VIII - analysis</subject><subject>Factor Xa - metabolism</subject><subject>France</subject><subject>FVIII‐assay</subject><subject>hemophilia A</subject><subject>Hemophilia A - blood</subject><subject>Hemophilia A - diagnosis</subject><subject>Humans</subject><subject>Kinetics</subject><subject>Middle Aged</subject><subject>Netherlands</subject><subject>Phenotype</subject><subject>Predictive Value of Tests</subject><subject>Reproducibility of Results</subject><subject>Sensitivity and Specificity</subject><subject>Severity of Illness Index</subject><subject>Thrombin - metabolism</subject><subject>Thromboplastin - metabolism</subject><subject>Young Adult</subject><issn>1538-7933</issn><issn>1538-7836</issn><issn>1538-7836</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><recordid>eNqNkMtOwzAQRS0E4v0LyDtWDXamaZwFiwoBDUJiUxA7a-LYras8WjuB5u9JaMsabzyyz70jHUIoZwHvz90q4BGIUSxgEoSM84CNIRLB9oic_30cH-YE4IxceL9ijCdRyE7JWcgnLAKAc-LmS1eXma3oQlfaYWPriqL32NHW22pBDaqmdjT9xP6ZIm2cXSy0o01NNy1WjTUdRaXaPqqL7oB_pGlKC_2lC0_77iXqsl4vbWGRTq_IicHC6-v9fUnenx7nD7PR69tz-jB9HakxF2JkTBxHSYwwQYVhyDKdZ4qLMIpjkxtQSqiER5ixsclz4JkRueAgMIEkzCdGwSW53fWuXb1ptW9kab3SRYGVrlsvhQBgcRiznhQ7Urnae6eNXDtbouskZ3IQLldycCkHr3IQLn-Fy20fvdkvabNS53_Bg-EeuN8B37bQ3b-L5ct8NkzwA-PYkIQ</recordid><startdate>201108</startdate><enddate>201108</enddate><creator>NINIVAGGI, M.</creator><creator>DARGAUD, Y.</creator><creator>Van OERLE, R.</creator><creator>De LAAT, B.</creator><creator>HEMKER, H. C.</creator><creator>LINDHOUT, T.</creator><general>Blackwell Publishing Ltd</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>201108</creationdate><title>Thrombin generation assay using factor IXa as a trigger to quantify accurately factor VIII levels in haemophilia A</title><author>NINIVAGGI, M. ; DARGAUD, Y. ; Van OERLE, R. ; De LAAT, B. ; HEMKER, H. C. ; LINDHOUT, T.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4188-ff77597a36aca220bedbc182577fdf3cc8c915ab04fdd31bf8d8138a9392d6fc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Biomarkers - blood</topic><topic>Blood Coagulation Tests</topic><topic>factor IXa‐driven thrombin generation</topic><topic>Factor VIII - analysis</topic><topic>Factor Xa - metabolism</topic><topic>France</topic><topic>FVIII‐assay</topic><topic>hemophilia A</topic><topic>Hemophilia A - blood</topic><topic>Hemophilia A - diagnosis</topic><topic>Humans</topic><topic>Kinetics</topic><topic>Middle Aged</topic><topic>Netherlands</topic><topic>Phenotype</topic><topic>Predictive Value of Tests</topic><topic>Reproducibility of Results</topic><topic>Sensitivity and Specificity</topic><topic>Severity of Illness Index</topic><topic>Thrombin - metabolism</topic><topic>Thromboplastin - metabolism</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>NINIVAGGI, M.</creatorcontrib><creatorcontrib>DARGAUD, Y.</creatorcontrib><creatorcontrib>Van OERLE, R.</creatorcontrib><creatorcontrib>De LAAT, B.</creatorcontrib><creatorcontrib>HEMKER, H. C.</creatorcontrib><creatorcontrib>LINDHOUT, T.</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>Journal of thrombosis and haemostasis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>NINIVAGGI, M.</au><au>DARGAUD, Y.</au><au>Van OERLE, R.</au><au>De LAAT, B.</au><au>HEMKER, H. C.</au><au>LINDHOUT, T.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Thrombin generation assay using factor IXa as a trigger to quantify accurately factor VIII levels in haemophilia A</atitle><jtitle>Journal of thrombosis and haemostasis</jtitle><addtitle>J Thromb Haemost</addtitle><date>2011-08</date><risdate>2011</risdate><volume>9</volume><issue>8</issue><spage>1549</spage><epage>1555</epage><pages>1549-1555</pages><issn>1538-7933</issn><issn>1538-7836</issn><eissn>1538-7836</eissn><abstract>Background: The available methods for measuring factor VIII (FVIII) activity suffer reportedly from lack of sensitivity and precision in the < 1 IU dL−1 range. This precludes correlation of clinical phenotype with FVIII levels. Objectives: To study a possible association between clinical phenotype in patients with FVIII levels < 1 IU dL−1. Methods/Results: The FIXa‐driven FVIII assay (FVIII‐CAT) has a detection limit of 0.05 IU dL−1. For the range of 0–2 IU dL−1 FVIII, the intra‐assay coefficient of variation (CV) is around 2% and the inter‐assay CV is about 8%. We tested 30 hemophiliacs with FVIII:C between < 1 and 6 IU dL−1 as measured in the one‐stage clotting assay using the FVIII‐CAT assay. For genetic defects related to moderate hemophilia, the FVIII‐CAT test finds FVIII levels that are in good agreement with those determined with the one‐stage assay. Of the 21 hemophilic patients with FVIII < 1 IU dL−1, four patients exhibited a mild bleeding phenotype. When we applied TF‐initiated thrombin generation, patients with a mild clinical phenotype showed significantly higher endogenous thrombin potentials. Conclusion: The novel developed FVIII assay measures accurately FVIII levels below 1 IU dL−1. Its application demonstrated that the clinical heterogeneity in individuals with < 1 IU dL−1 FVIII is not associated with their FVIII level.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>21605333</pmid><doi>10.1111/j.1538-7836.2011.04358.x</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of thrombosis and haemostasis, 2011-08, Vol.9 (8), p.1549-1555 |
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| subjects | Adult Aged Biomarkers - blood Blood Coagulation Tests factor IXa‐driven thrombin generation Factor VIII - analysis Factor Xa - metabolism France FVIII‐assay hemophilia A Hemophilia A - blood Hemophilia A - diagnosis Humans Kinetics Middle Aged Netherlands Phenotype Predictive Value of Tests Reproducibility of Results Sensitivity and Specificity Severity of Illness Index Thrombin - metabolism Thromboplastin - metabolism Young Adult |
| title | Thrombin generation assay using factor IXa as a trigger to quantify accurately factor VIII levels in haemophilia A |
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