{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T09:04:30Z","timestamp":1792746270920,"version":"4.5.0"},"reference-count":29,"publisher":"Georg Thieme Verlag KG","issue":"06","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Semin Thromb Hemost"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>D-dimers represent the breakdown products of fibrin. Thus, elevated plasma D-dimers will arise following a thrombotic event, such as a deep vein thrombosis or a pulmonary embolism, and therefore, a nonelevated D-dimer is used to effectively exclude such events. D-dimers are also elevated in a range of other conditions, for example, during disseminated intravascular coagulation. D-dimer levels may also be associated with prognostic value. For example, highly raised D-dimer levels can be associated with worsening clinical features in coronavirus disease 2019. Thus, D-dimer testing represents a commonly requested hemostasis test, often performed in 24\/7 laboratories. Unfortunately, D-dimer testing is neither standardized nor harmonized across manufacturers or laboratories. Indeed, considering reporting units and the magnitude of units, up to 28 different combinations may be reported by laboratories. We provide updated findings for D-dimer testing in our geographic region, using recent data from the Royal College of Pathologists of Australasia Quality Assurance Programs, an international external quality assessment program, currently with over 450 participants in the D-dimer module. Data show a wide variety of assays in use and variable outcomes in reported numerical values when assessing proficiency samples. D-dimer testing mostly comprised reagents from three main manufacturing suppliers, with a small number of users of reagents from other manufacturers. Reported results showed important differences in numerical values for the same homogeneous tested samples when normalized to a single reporting unit (e.g., mg\/L). Nevertheless, despite using different test reagents and reporting, most participants uniformly identified D-dimer values as below or above a \u201cdetection\u201d cut-off for samples that were constructed to be below or above most cut-off values. As expected, mixed findings were reported for samples containing levels around expected cut-off values. We hope that our findings, reflecting on the heterogeneity of test reagents and test data, help improve diagnostic testing for D-dimer testing and facilitate harmonization and standardization, in the future.<\/jats:p>","DOI":"10.1055\/s-0044-1781450","type":"journal-article","created":{"date-parts":[[2024,3,1]],"date-time":"2024-03-01T19:14:43Z","timestamp":1709320483000},"page":"629-640","source":"Crossref","is-referenced-by-count":8,"title":["Variable Performance of D-dimer Testing by Hemostasis Laboratories: The Australasian\/Asia-Pacific Experience"],"prefix":"10.1055","volume":"51","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2103-1661","authenticated-orcid":false,"given":"Emmanuel J.","family":"Favaloro","sequence":"additional","affiliation":[{"name":"Department of Haematology, Sydney Centres for Thrombosis and Haemostasis, Institute of Clinical Pathology and Medical Research (ICPMR), NSW Health Pathology, Westmead Hospital, Westmead, NSW, Australia"},{"name":"Faculty of Science and Health, Charles Sturt University, Wagga Wagga, NSW, Australia"},{"name":"School of Medical Sciences, Faculty of Medicine and Health, University of Sydney, Westmead Hospital, Westmead, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandya","family":"Arunachalam","sequence":"additional","affiliation":[{"name":"RCPAQAP Haematology, St Leonards, NSW, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elysse","family":"Dean","sequence":"additional","affiliation":[{"name":"RCPAQAP Haematology, St Leonards, NSW, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2024,3,1]]},"reference":[{"issue":"06","key":"ref1","doi-asserted-by":"crossref","first-page":"672","DOI":"10.1055\/s-0042-1748193","article-title":"D-dimers-\u201cnormal\u201d levels versus elevated levels due to a range of conditions, including \u201cD-dimeritis,\u201d inflammation, thromboembolism, disseminated intravascular coagulation, and COVID-19","volume":"48","author":"J Thachil","year":"2022","journal-title":"Semin Thromb Hemost"},{"issue":"05","key":"ref2","doi-asserted-by":"crossref","first-page":"876","DOI":"10.1055\/s-0040-1709650","article-title":"D-dimer is associated with severity of coronavirus disease 2019 (COVID-19): a pooled analysis","volume":"120","author":"G Lippi","year":"2020","journal-title":"Thromb Haemost"},{"key":"ref3","doi-asserted-by":"crossref","first-page":"635","DOI":"10.1016\/j.thromres.2020.09.040","article-title":"D-dimer measurement in COVID-19: silver bullet or clinical distraction?","volume":"196","author":"G Lippi","year":"2020","journal-title":"Thromb Res"},{"issue":"01","key":"ref4","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1515\/cclm-2021-1039","article-title":"Review and evolution of guidelines for diagnosis of COVID-19 vaccine induced thrombotic thrombocytopenia (VITT)","volume":"60","author":"E J Favaloro","year":"2021","journal-title":"Clin Chem Lab Med"},{"issue":"12","key":"ref5","doi-asserted-by":"crossref","first-page":"2896","DOI":"10.1111\/jth.15881","article-title":"Assessment of immunological anti-platelet factor 4 antibodies for vaccine-induced thrombotic thrombocytopenia (VITT) in a large Australian cohort: a multicenter study comprising 1284 patients","volume":"20","author":"E J Favaloro","year":"2022","journal-title":"J Thromb Haemost"},{"key":"ref6","doi-asserted-by":"crossref","first-page":"219","DOI":"10.1016\/j.thromres.2015.11.031","article-title":"Harmonisation of D-dimer\u2014a call for action","volume":"137","author":"C Longstaff","year":"2016","journal-title":"Thromb Res"},{"issue":"03","key":"ref7","doi-asserted-by":"crossref","first-page":"287","DOI":"10.1055\/s-0035-1549092","article-title":"International survey on D-dimer test reporting: a call for standardization","volume":"41","author":"G Lippi","year":"2015","journal-title":"Semin Thromb Hemost"},{"issue":"04","key":"ref8","doi-asserted-by":"crossref","first-page":"538","DOI":"10.1016\/j.pathol.2020.08.010","article-title":"Variability in D-dimer reporting revisited","volume":"53","author":"E J Favaloro","year":"2021","journal-title":"Pathology"},{"issue":"08","key":"ref9","doi-asserted-by":"crossref","first-page":"1191","DOI":"10.1515\/cclm-2020-0573","article-title":"Reporting of D-dimer data in COVID-19: some confusion and potential for misinformation","volume":"58","author":"E J Favaloro","year":"2020","journal-title":"Clin Chem Lab Med"},{"key":"ref10","volume-title":"Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline","author":"CLSI","year":"2011"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1016\/j.rpth.2024.102335","article-title":"D-dimer diagnostics: can i use any D-dimer assay? Bridging the knowledge-to-action gap","author":"S Selby","year":"2024","journal-title":"Res Pract Thromb Haemost"},{"issue":"02","key":"ref12","doi-asserted-by":"crossref","first-page":"407","DOI":"10.1111\/ijlh.13760","article-title":"Impact of COVID-19 pandemic on the quality of test output in haemostasis laboratories","volume":"44","author":"R A Arisz","year":"2022","journal-title":"Int J Lab Hematol"},{"issue":"01","key":"ref13","doi-asserted-by":"crossref","first-page":"155","DOI":"10.1016\/j.pathol.2022.02.013","article-title":"Pathology utilisation during COVID-19 outbreaks beyond viral testing: routine coagulation and D-dimer testing","volume":"55","author":"E J Favaloro","year":"2023","journal-title":"Pathology"},{"issue":"S 01","key":"ref14","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1111\/ijlh.12998","article-title":"What have we learned from coagulation laboratory participation in external quality programs?","volume":"41","author":"K J Smock","year":"2019","journal-title":"Int J Lab Hematol"},{"issue":"02","key":"ref15","doi-asserted-by":"crossref","first-page":"298","DOI":"10.1111\/ijlh.12973","article-title":"A pilot study to introduce a local external quality assurance scheme for D-dimers in the National Health Laboratory Service, in South Africa","volume":"41","author":"H Aggett","year":"2019","journal-title":"Int J Lab Hematol"},{"issue":"06","key":"ref16","doi-asserted-by":"crossref","first-page":"625","DOI":"10.1055\/s-2000-13218","article-title":"Performance of semiquantitative and quantitative D-dimer assays in the ECAT external quality assessment program","volume":"26","author":"M P de Maat","year":"2000","journal-title":"Semin Thromb Hemost"},{"issue":"S 02","key":"ref17","first-page":"99","article-title":"Quality control and quality assessment of coagulation tests in Japan","volume":"33","author":"K Matsuno","year":"2002","journal-title":"Southeast Asian J Trop Med Public Health"},{"issue":"05","key":"ref18","first-page":"54","article-title":"Proficiency testing finds too-high cutoffs","volume":"19","author":"M T Cunningham","year":"2005","journal-title":"CAP Today"},{"issue":"06","key":"ref19","doi-asserted-by":"crossref","first-page":"439","DOI":"10.1097\/01.mbc.0000179912.80656.2b","article-title":"The performance of quantitative D-dimer assays in laboratory routine","volume":"16","author":"M Spannagl","year":"2005","journal-title":"Blood Coagul Fibrinolysis"},{"issue":"01","key":"ref20","doi-asserted-by":"crossref","first-page":"184","DOI":"10.1111\/j.1538-7836.2006.02252.x","article-title":"Performance of quantitative D-dimer methods: results of the Italian external quality assessment scheme","volume":"5","author":"A Tripodi","year":"2007","journal-title":"J Thromb Haemost"},{"issue":"03","key":"ref21","doi-asserted-by":"crossref","first-page":"235","DOI":"10.1055\/s-2007-971809","article-title":"Emerging technologies and quality assurance in hemostasis: a review of findings from the Royal College of Pathologists of Australasia Quality Assurance Program","volume":"33","author":"E J Favaloro","year":"2007","journal-title":"Semin Thromb Hemost"},{"issue":"03","key":"ref22","doi-asserted-by":"crossref","first-page":"243","DOI":"10.1055\/s-2007-971810","article-title":"Emerging technologies and quality assurance: the United Kingdom National External Quality Assessment Scheme perspective","volume":"33","author":"I Jennings","year":"2007","journal-title":"Semin Thromb Hemost"},{"issue":"03","key":"ref23","doi-asserted-by":"crossref","first-page":"290","DOI":"10.1055\/s-2007-971816","article-title":"Standardization, regulation, quality assurance and emerging technologies in hemostasis: issues, controversies, benefits, and limitations","volume":"33","author":"E J Favaloro","year":"2007","journal-title":"Semin Thromb Hemost"},{"issue":"05","key":"ref24","doi-asserted-by":"crossref","first-page":"805","DOI":"10.1309\/AJCPUBFRQ8Q6ZWTY","article-title":"Human-derived D-dimer for external quality assessment: results of four surveys in Ontario","volume":"130","author":"M A Crowther","year":"2008","journal-title":"Am J Clin Pathol"},{"issue":"08","key":"ref25","doi-asserted-by":"crossref","first-page":"1030","DOI":"10.5858\/arpa.2012-0296-CP","article-title":"D-dimer: simple test, tough problems","volume":"137","author":"J D Olson","year":"2013","journal-title":"Arch Pathol Lab Med"},{"issue":"02","key":"ref26","doi-asserted-by":"crossref","first-page":"498","DOI":"10.1111\/jth.15555","article-title":"Is it possible to make a common reference standard for D-dimer measurements? Communication from the ISTH SSC Subcommittee on Fibrinolysis","volume":"20","author":"S Bevan","year":"2022","journal-title":"J Thromb Haemost"},{"issue":"03","key":"ref27","doi-asserted-by":"crossref","first-page":"567","DOI":"10.1160\/TH05-01-0042","article-title":"A model for the harmonisation of test results of different quantitative D-dimer methods","volume":"95","author":"P Meijer","year":"2006","journal-title":"Thromb Haemost"},{"issue":"01","key":"ref28","doi-asserted-by":"crossref","first-page":"103","DOI":"10.1007\/s11239-021-02527-y","article-title":"Harmonized D-dimer levels upon admission for prognosis of COVID-19 severity: results from a Spanish multicenter registry (BIOCOVID-Spain study)","volume":"53","author":"L Garc\u00eda de Guadiana-Romualdo","year":"2022","journal-title":"J Thromb Thrombolysis"},{"issue":"09","key":"ref29","doi-asserted-by":"crossref","first-page":"2408","DOI":"10.1111\/jth.14956","article-title":"The need for accurate D-dimer reporting in COVID-19: communication from the ISTH SSC on fibrinolysis","volume":"18","author":"J Thachil","year":"2020","journal-title":"J Thromb Haemost"}],"container-title":["Seminars in Thrombosis and Hemostasis"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/s-0044-1781450.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,14]],"date-time":"2025-08-14T23:42:05Z","timestamp":1755214925000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/s-0044-1781450"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,3,1]]},"references-count":29,"journal-issue":{"issue":"06","published-online":{"date-parts":[[2025,8,8]]},"published-print":{"date-parts":[[2025,9]]}},"URL":"https:\/\/doi.org\/10.1055\/s-0044-1781450","archive":["Portico","CLOCKSS"],"relation":{},"ISSN":["0094-6176","1098-9064"],"issn-type":[{"value":"0094-6176","type":"print"},{"value":"1098-9064","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,3,1]]}}}