Development of a novel automated screening method for detection of FVIII Inhibitors
Summary Introduction Factor VIII activity is routinely determined by measuring the activated partial thromboplastin time (aPTT) of a patient plasma sample and determining percent activity from a standard curve. To maximize the detection of a clotting factor inhibitor, a subjective assessment of para...
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| Veröffentlicht in: | International journal of laboratory hematology 2017-04, Vol.39 (2), p.185-190 |
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| creator | Evans, M. S. Donaldson, K. J. Eyster, M. E. |
| description | Summary
Introduction
Factor VIII activity is routinely determined by measuring the activated partial thromboplastin time (aPTT) of a patient plasma sample and determining percent activity from a standard curve. To maximize the detection of a clotting factor inhibitor, a subjective assessment of parallelism of a patient curve compared with a standard curve is performed. We developed and validated an automated objective method to assess parallelism as a rapid screening tool for detection of an inhibitor to factor VIII during routine FVIII assays.
Methods
We performed FVIII assays on a subset of FVIII‐deficient patients with hemophilia A with and without inhibitors. Utilizing a ratio of the slopes from parallelism curves obtained by an independent Microsoft excel program in patients compared with a normal standard curve, we determined a cutoff ratio predictive for presence of an inhibitor.
Results
A cutoff ratio of patient to control slopes of |
| doi_str_mv | 10.1111/ijlh.12601 |
| format | Article |
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Introduction
Factor VIII activity is routinely determined by measuring the activated partial thromboplastin time (aPTT) of a patient plasma sample and determining percent activity from a standard curve. To maximize the detection of a clotting factor inhibitor, a subjective assessment of parallelism of a patient curve compared with a standard curve is performed. We developed and validated an automated objective method to assess parallelism as a rapid screening tool for detection of an inhibitor to factor VIII during routine FVIII assays.
Methods
We performed FVIII assays on a subset of FVIII‐deficient patients with hemophilia A with and without inhibitors. Utilizing a ratio of the slopes from parallelism curves obtained by an independent Microsoft excel program in patients compared with a normal standard curve, we determined a cutoff ratio predictive for presence of an inhibitor.
Results
A cutoff ratio of patient to control slopes of <0.45 for the detection of an inhibitor to FVIII was 100% sensitive and 91.6% specific, with a positive predictive value of 92.3% and a negative predictive value of 100%.
Conclusion
Utilizing a ratio of the slopes from parallelism curves in patients with and without an inhibitor, we developed and validated a rapid, automated, and objective method to assess parallelism as an added screening tool for detection of an inhibitor to factor VIII during routine FVIII assays on a STAGO‐based coagulation platform. This simple automated method has the potential to detect inhibitors to other clotting factors.</description><identifier>ISSN: 1751-5521</identifier><identifier>EISSN: 1751-553X</identifier><identifier>DOI: 10.1111/ijlh.12601</identifier><identifier>PMID: 28133956</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Autoantibodies - blood ; automated laboratory screening ; Automation ; Blood Coagulation Tests ; Clotting ; Coagulation ; Coagulation factors ; coagulation inhibitors ; Factor VIII - analysis ; Factor VIII - antagonists & inhibitors ; Factor VIII - immunology ; Factor VIII deficiency ; Female ; FVIII ; Hemophilia ; Hemophilia A - diagnosis ; Hemorrhage ; High-Throughput Screening Assays - methods ; Humans ; inhibitors ; Male ; Patients ; Predictive Value of Tests ; Sensitivity and Specificity ; Thromboplastin</subject><ispartof>International journal of laboratory hematology, 2017-04, Vol.39 (2), p.185-190</ispartof><rights>2017 John Wiley & Sons Ltd</rights><rights>2017 John Wiley & Sons Ltd.</rights><rights>Copyright © 2017 John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3901-25aa536ad513fa9509880cae61ac54497120e535dd7c58c68acda25b39af484f3</citedby><cites>FETCH-LOGICAL-c3901-25aa536ad513fa9509880cae61ac54497120e535dd7c58c68acda25b39af484f3</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%2Fijlh.12601$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fijlh.12601$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28133956$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Evans, M. S.</creatorcontrib><creatorcontrib>Donaldson, K. J.</creatorcontrib><creatorcontrib>Eyster, M. E.</creatorcontrib><title>Development of a novel automated screening method for detection of FVIII Inhibitors</title><title>International journal of laboratory hematology</title><addtitle>Int J Lab Hematol</addtitle><description>Summary
Introduction
Factor VIII activity is routinely determined by measuring the activated partial thromboplastin time (aPTT) of a patient plasma sample and determining percent activity from a standard curve. To maximize the detection of a clotting factor inhibitor, a subjective assessment of parallelism of a patient curve compared with a standard curve is performed. We developed and validated an automated objective method to assess parallelism as a rapid screening tool for detection of an inhibitor to factor VIII during routine FVIII assays.
Methods
We performed FVIII assays on a subset of FVIII‐deficient patients with hemophilia A with and without inhibitors. Utilizing a ratio of the slopes from parallelism curves obtained by an independent Microsoft excel program in patients compared with a normal standard curve, we determined a cutoff ratio predictive for presence of an inhibitor.
Results
A cutoff ratio of patient to control slopes of <0.45 for the detection of an inhibitor to FVIII was 100% sensitive and 91.6% specific, with a positive predictive value of 92.3% and a negative predictive value of 100%.
Conclusion
Utilizing a ratio of the slopes from parallelism curves in patients with and without an inhibitor, we developed and validated a rapid, automated, and objective method to assess parallelism as an added screening tool for detection of an inhibitor to factor VIII during routine FVIII assays on a STAGO‐based coagulation platform. This simple automated method has the potential to detect inhibitors to other clotting factors.</description><subject>Autoantibodies - blood</subject><subject>automated laboratory screening</subject><subject>Automation</subject><subject>Blood Coagulation Tests</subject><subject>Clotting</subject><subject>Coagulation</subject><subject>Coagulation factors</subject><subject>coagulation inhibitors</subject><subject>Factor VIII - analysis</subject><subject>Factor VIII - antagonists & inhibitors</subject><subject>Factor VIII - immunology</subject><subject>Factor VIII deficiency</subject><subject>Female</subject><subject>FVIII</subject><subject>Hemophilia</subject><subject>Hemophilia A - diagnosis</subject><subject>Hemorrhage</subject><subject>High-Throughput Screening Assays - methods</subject><subject>Humans</subject><subject>inhibitors</subject><subject>Male</subject><subject>Patients</subject><subject>Predictive Value of Tests</subject><subject>Sensitivity and Specificity</subject><subject>Thromboplastin</subject><issn>1751-5521</issn><issn>1751-553X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqN0U1r2zAYB3AxWtY022UfoAh6KYV0eiRLlo6lb3EJ9LAXdhOK_HhxsK1Usjv67essXQ47lOoiIX76P4g_IV-AXcC4vtbrZnUBXDH4QCaQS5hJKX4d7M8cjshxSmvGZJ4x85EccQ1CGKkm5Ns1PmETNi12PQ0VdbQL4wV1Qx9a12NJk4-IXd39pi32q1DSKkRaYo--r0O3fXP7sygKWnSreln3IaZP5LByTcLPr_uU_Li9-X41ny0e7oqry8XMC8NgxqVzUihXShCVM5IZrZl3qMB5mWUmB85QClmWuZfaK-186bhcCuOqTGeVmJKzXe4mhscBU2_bOnlsGtdhGJIFrSFXUmn-Dqq4GWcyMdLT_-g6DLEbP2LBcJZpYVQ2qvOd8jGkFLGym1i3Lj5bYHbbit22Yv-2MuKT18hh2WK5p_9qGAHswJ-6wec3omxxv5jvQl8A4lSVmg</recordid><startdate>201704</startdate><enddate>201704</enddate><creator>Evans, M. S.</creator><creator>Donaldson, K. J.</creator><creator>Eyster, M. E.</creator><general>Wiley Subscription Services, 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>7T5</scope><scope>H94</scope><scope>7X8</scope></search><sort><creationdate>201704</creationdate><title>Development of a novel automated screening method for detection of FVIII Inhibitors</title><author>Evans, M. S. ; Donaldson, K. J. ; Eyster, M. E.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3901-25aa536ad513fa9509880cae61ac54497120e535dd7c58c68acda25b39af484f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Autoantibodies - blood</topic><topic>automated laboratory screening</topic><topic>Automation</topic><topic>Blood Coagulation Tests</topic><topic>Clotting</topic><topic>Coagulation</topic><topic>Coagulation factors</topic><topic>coagulation inhibitors</topic><topic>Factor VIII - analysis</topic><topic>Factor VIII - antagonists & inhibitors</topic><topic>Factor VIII - immunology</topic><topic>Factor VIII deficiency</topic><topic>Female</topic><topic>FVIII</topic><topic>Hemophilia</topic><topic>Hemophilia A - diagnosis</topic><topic>Hemorrhage</topic><topic>High-Throughput Screening Assays - methods</topic><topic>Humans</topic><topic>inhibitors</topic><topic>Male</topic><topic>Patients</topic><topic>Predictive Value of Tests</topic><topic>Sensitivity and Specificity</topic><topic>Thromboplastin</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Evans, M. S.</creatorcontrib><creatorcontrib>Donaldson, K. J.</creatorcontrib><creatorcontrib>Eyster, M. E.</creatorcontrib><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>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of laboratory hematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Evans, M. S.</au><au>Donaldson, K. J.</au><au>Eyster, M. E.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Development of a novel automated screening method for detection of FVIII Inhibitors</atitle><jtitle>International journal of laboratory hematology</jtitle><addtitle>Int J Lab Hematol</addtitle><date>2017-04</date><risdate>2017</risdate><volume>39</volume><issue>2</issue><spage>185</spage><epage>190</epage><pages>185-190</pages><issn>1751-5521</issn><eissn>1751-553X</eissn><abstract>Summary
Introduction
Factor VIII activity is routinely determined by measuring the activated partial thromboplastin time (aPTT) of a patient plasma sample and determining percent activity from a standard curve. To maximize the detection of a clotting factor inhibitor, a subjective assessment of parallelism of a patient curve compared with a standard curve is performed. We developed and validated an automated objective method to assess parallelism as a rapid screening tool for detection of an inhibitor to factor VIII during routine FVIII assays.
Methods
We performed FVIII assays on a subset of FVIII‐deficient patients with hemophilia A with and without inhibitors. Utilizing a ratio of the slopes from parallelism curves obtained by an independent Microsoft excel program in patients compared with a normal standard curve, we determined a cutoff ratio predictive for presence of an inhibitor.
Results
A cutoff ratio of patient to control slopes of <0.45 for the detection of an inhibitor to FVIII was 100% sensitive and 91.6% specific, with a positive predictive value of 92.3% and a negative predictive value of 100%.
Conclusion
Utilizing a ratio of the slopes from parallelism curves in patients with and without an inhibitor, we developed and validated a rapid, automated, and objective method to assess parallelism as an added screening tool for detection of an inhibitor to factor VIII during routine FVIII assays on a STAGO‐based coagulation platform. This simple automated method has the potential to detect inhibitors to other clotting factors.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>28133956</pmid><doi>10.1111/ijlh.12601</doi><tpages>6</tpages></addata></record> |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Autoantibodies - blood automated laboratory screening Automation Blood Coagulation Tests Clotting Coagulation Coagulation factors coagulation inhibitors Factor VIII - analysis Factor VIII - antagonists & inhibitors Factor VIII - immunology Factor VIII deficiency Female FVIII Hemophilia Hemophilia A - diagnosis Hemorrhage High-Throughput Screening Assays - methods Humans inhibitors Male Patients Predictive Value of Tests Sensitivity and Specificity Thromboplastin |
| title | Development of a novel automated screening method for detection of FVIII Inhibitors |
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