{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T00:28:48Z","timestamp":1778718528958,"version":"3.51.4"},"reference-count":23,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2024,7,24]],"date-time":"2024-07-24T00:00:00Z","timestamp":1721779200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,9,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Historically, von Willebrand factor (VWF) activity assays utilized ristocetin despite limitations including poor limits of detection and high imprecision. Newer VWF activity assays such as the INNOVANCE\u00ae VWF Ac assay, however, do not rely on ristocetin to measure platelet-dependent VWF function. The purpose of this study was to evaluate the analytical and clinical performance of the Siemens Healthineers INNOVANCE VWF Ac Assay on the Siemens BCS\u00ae XP and the Sysmex\u00ae CS-2500 systems in a large reference laboratory setting.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Performance indicators for the INNOVANCE VWF Ac assay were the limit of quantitation (LoQ), precision, and method comparison. Method comparison studies were performed using remnant plasma patient samples from routine coagulation tests and analyzed using both the INNOVANCE VWF Ac assay and the Siemens Healthineers ristocetin-dependent BC von Willebrand Reagent.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Evaluation of the INNOVANCE VWF Ac assay on the BCS\u00ae XP and CS-2500 systems demonstrated good precision and a lower LoQ compared to the BC von Willebrand Reagent. Method comparisons support the use of the INNOVANCE VWF Ac assay on the BCS\u00ae XP and CS-2500 systems to measure platelet-dependent VWF function. The INNOVANCE VWF Ac assay was able to further assist in von Willebrand disease classification in 6\/7 (86%) samples when the result was below the LoQ for the BC von Willebrand Reagent (ristocetin cofactor activity).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>These data are consistent with the 2021 American Society of Hematology\/International Society on Thrombosis and Haemostasis\/National Hemophilia Foundation\/World Federation of Hemophilia von Willebrand disease guidelines that suggest using newer assays such as the INNOVANCE VWF Ac assay in place of ristocetin cofactor activity assays.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jalm\/jfae063","type":"journal-article","created":{"date-parts":[[2024,7,25]],"date-time":"2024-07-25T02:35:38Z","timestamp":1721874938000},"page":"926-939","source":"Crossref","is-referenced-by-count":1,"title":["Analytical and Clinical Validation of a Non-Ristocetin Based VWF Assay on 2 Automated Analyzers in a Large Reference Laboratory"],"prefix":"10.1093","volume":"9","author":[{"given":"Vivek","family":"Kumar","sequence":"first","affiliation":[{"name":"Quest Diagnostics , Secaucus, NJ , United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Debra","family":"Goode","sequence":"additional","affiliation":[{"name":"Quest Diagnostics , Secaucus, NJ , United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura A","family":"Worfolk","sequence":"additional","affiliation":[{"name":"Quest Diagnostics , Secaucus, NJ , United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeanne","family":"Rhea-McManus","sequence":"additional","affiliation":[{"name":"Siemens Healthcare Diagnostics Inc. , Tarrytown, NY , United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John V","family":"Mitsios","sequence":"additional","affiliation":[{"name":"Siemens Healthcare Diagnostics Inc. , Tarrytown, NY , United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7645-4277","authenticated-orcid":false,"given":"Edward C C","family":"Wong","sequence":"additional","affiliation":[{"name":"Quest Diagnostics , Secaucus, NJ , United States"},{"name":"Department of Pediatrics, George Washington School of Medicine and Health Sciences , Washington, DC , United States"},{"name":"Department of Pathology, George Washington School of Medicine and Health Sciences , Washington, DC , United States"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2024,7,24]]},"reference":[{"key":"2024090311495541600_jfae063-B1","doi-asserted-by":"crossref","first-page":"213","DOI":"10.1111\/j.1538-7836.2009.03661.x","article-title":"The prevalence of symptomatic von Willebrand disease in primary care practice","volume":"8","author":"Bowman","year":"2010","journal-title":"J Thromb Haemost"},{"key":"2024090311495541600_jfae063-B2","doi-asserted-by":"crossref","first-page":"280","DOI":"10.1182\/blood-2009-10-249102","article-title":"Common VWF exon 28 polymorphisms in African Americans affecting the VWF activity assay by ristocetin cofactor","volume":"116","author":"Flood","year":"2010","journal-title":"Blood"},{"key":"2024090311495541600_jfae063-B3","doi-asserted-by":"crossref","first-page":"280","DOI":"10.1182\/bloodadvances.2020003265","article-title":"ASH ISTH NHF WFH 2021 guidelines on the diagnosis of von Willebrand disease","volume":"5","author":"James","year":"2021","journal-title":"Blood Adv"},{"key":"2024090311495541600_jfae063-B4","doi-asserted-by":"crossref","first-page":"453","DOI":"10.1111\/bjh.13064","article-title":"The diagnosis and management of von Willebrand disease: a United Kingdom Haemophilia Centre Doctors Organization guideline approved by the British Committee for Standards in Haematology","volume":"167","author":"Laffan","year":"2014","journal-title":"Br J Haematol"},{"key":"2024090311495541600_jfae063-B5","doi-asserted-by":"crossref","first-page":"366","DOI":"10.1002\/ajh.21405","article-title":"Clinical and laboratory diagnosis of von Willebrand disease: a synopsis of the 2008 NHLBI\/NIH guidelines","volume":"84","author":"Nichols","year":"2009","journal-title":"Am J Hematol"},{"key":"2024090311495541600_jfae063-B6","doi-asserted-by":"crossref","first-page":"2103","DOI":"10.1111\/j.1538-7836.2006.02146.x","article-title":"Update on the pathophysiology and classification of von Willebrand disease: a report of the Subcommittee on von Willebrand Factor","volume":"4","author":"Sadler","year":"2006","journal-title":"J Thromb Haemost"},{"key":"2024090311495541600_jfae063-B7","doi-asserted-by":"crossref","first-page":"775","DOI":"10.1111\/j.1538-7836.2005.01245.x","article-title":"Provisional criteria for the diagnosis of VWD type 1","volume":"3","author":"Sadler","year":"2005","journal-title":"J Thromb Haemost"},{"key":"2024090311495541600_jfae063-B8","doi-asserted-by":"crossref","first-page":"301","DOI":"10.1182\/bloodadvances.2020003264","article-title":"ASH ISTH NHF WFH 2021 guidelines on the management of von Willebrand disease","volume":"5","author":"Connell","year":"2021","journal-title":"Blood Adv"},{"key":"2024090311495541600_jfae063-B9","doi-asserted-by":"crossref","first-page":"739","DOI":"10.1055\/s-0042-1754354","article-title":"How do laboratories perform von Willebrand disease diagnostics and classification of von Willebrand disease patients? Results from external quality data and an international survey","volume":"48","author":"Hollestelle","year":"2022","journal-title":"Semin Thromb Hemost"},{"key":"2024090311495541600_jfae063-B10","doi-asserted-by":"crossref","first-page":"171","DOI":"10.1111\/j.1365-2516.2007.01643.x","article-title":"von Willebrand disease (VWD): evidence-based diagnosis and management guidelines, the National Heart, Lung, and Blood Institute (NHLBI) expert panel report (USA)","volume":"14","author":"Nichols","year":"2008","journal-title":"Haemophilia"},{"key":"2024090311495541600_jfae063-B11","doi-asserted-by":"crossref","first-page":"62","DOI":"10.1182\/bloodadvances.2021005430","article-title":"von Willebrand factor levels in the diagnosis of von Willebrand disease: a systematic review and meta-analysis","volume":"6","author":"Kalot","year":"2022","journal-title":"Blood Adv"},{"key":"2024090311495541600_jfae063-B12","doi-asserted-by":"crossref","first-page":"492","DOI":"10.1055\/s-2006-947863","article-title":"Laboratory tests for measurement of von Willebrand factor show poor agreement among different centers: results from the United Kingdom National External Quality Assessment Scheme for Blood Coagulation","volume":"32","author":"Kitchen","year":"2006","journal-title":"Semin Thromb Hemost"},{"key":"2024090311495541600_jfae063-B13","doi-asserted-by":"crossref","first-page":"e211","DOI":"10.1111\/hae.12384","article-title":"Diagnostic challenges in patients with bleeding phenotype and von Willebrand exon 28 polymorphism p.D1472H","volume":"20","author":"Francis","year":"2014","journal-title":"Haemophilia"},{"key":"2024090311495541600_jfae063-B14","doi-asserted-by":"crossref","first-page":"e67","DOI":"10.1182\/blood-2010-08-299016","article-title":"Gain-of-function GPIb ELISA assay for VWF activity in the Zimmerman Program for the Molecular and Clinical Biology of VWD","volume":"117","author":"Flood","year":"2011","journal-title":"Blood"},{"key":"2024090311495541600_jfae063-B15","doi-asserted-by":"crossref","first-page":"217","DOI":"10.1093\/clinchem\/9.2.217","article-title":"A study of the accuracy and precision of clinical chemistry determinations in 170 Canadian laboratories","volume":"9","author":"Tonks","year":"1963","journal-title":"Clin Chem"},{"key":"2024090311495541600_jfae063-B16","first-page":"38","article-title":"A quality control program for quantitative clinical chemistry estimations","volume":"30","author":"Tonks","year":"1968","journal-title":"Can J Med Technol"},{"key":"2024090311495541600_jfae063-B17","volume-title":"Basic method validation","author":"Westgard","year":"2008"},{"key":"2024090311495541600_jfae063-B18","doi-asserted-by":"crossref","first-page":"338","DOI":"10.1111\/hae.12064","article-title":"A comparative evaluation of a new automated assay for von Willebrand factor activity","volume":"19","author":"Lawrie","year":"2013","journal-title":"Haemophilia"},{"key":"2024090311495541600_jfae063-B19","doi-asserted-by":"crossref","first-page":"341","DOI":"10.1111\/ijlh.12218","article-title":"Evaluation of an automated method for measuring von Willebrand factor activity in clinical samples without ristocetin","volume":"36","author":"Graf","year":"2014","journal-title":"Int J Lab Hematol"},{"key":"2024090311495541600_jfae063-B20","doi-asserted-by":"crossref","first-page":"860","DOI":"10.1097\/MBC.0000000000000169","article-title":"Performance evaluation and multicentre study of a von Willebrand factor activity assay based on GPIb binding in the absence of ristocetin","volume":"25","author":"Patzke","year":"2014","journal-title":"Blood Coagul Fibrinolysis"},{"key":"2024090311495541600_jfae063-B21","doi-asserted-by":"crossref","first-page":"416","DOI":"10.1182\/bloodadvances.2021005946","article-title":"Commentary on the ASH ISTH NHF WFH 2021 guidelines on the diagnosis of VWD: reflections based on recent contemporary test data","volume":"6","author":"Favaloro","year":"2022","journal-title":"Blood Adv"},{"key":"2024090311495541600_jfae063-B22","doi-asserted-by":"crossref","first-page":"2842","DOI":"10.1111\/j.1538-7836.2010.04123.x","article-title":"Validation of improved performance characteristics for the automated von Willebrand factor ristocetin cofactor activity assay","volume":"8","author":"Favaloro","year":"2010","journal-title":"J Thromb Haemost"},{"key":"2024090311495541600_jfae063-B23","doi-asserted-by":"crossref","first-page":"690","DOI":"10.1055\/s-0042-1749591","article-title":"Analysis of College of American Pathologists von Willebrand Factor Proficiency Testing Program","volume":"48","author":"Salazar","year":"2022","journal-title":"Semin Thromb Hemost"}],"container-title":["The Journal of Applied Laboratory Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jalm\/article-pdf\/9\/5\/926\/59001207\/jfae063.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jalm\/article-pdf\/9\/5\/926\/59001207\/jfae063.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,9,3]],"date-time":"2024-09-03T13:48:57Z","timestamp":1725371337000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jalm\/article\/9\/5\/926\/7719019"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,24]]},"references-count":23,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2024,7,24]]},"published-print":{"date-parts":[[2024,9,3]]}},"URL":"https:\/\/doi.org\/10.1093\/jalm\/jfae063","relation":{},"ISSN":["2475-7241"],"issn-type":[{"value":"2475-7241","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2024,9]]},"published":{"date-parts":[[2024,7,24]]}}}