Skip to main content
SpringerLink
Log in

Protocols for D-Dimer Measurements for Aid to Diagnosis or Exclusion of Venous Thromboembolism

  • Protocol
  • First Online:
Hemostasis and Thrombosis

Part of the book series: Methods in Molecular Biology ((MIMB,volume 2663))

  • 1800 Accesses

Abstract

Measuring D-dimer is commonly used as a surrogate to indicate a clot-forming process, with subsequent lysis. This test has two primary intended uses: (1) as aid to diagnosis of various conditions and (2) venous thromboembolism (VTE) exclusion. If the manufacturer cites a VTE exclusion claim, the D-dimer test must only be used in evaluating patients with a non-high or unlikely pretest probability for pulmonary embolism and deep vein thrombosis. D-dimer kits with only aid to diagnosis claim should not be used for VTE exclusion. The intended use of the D-dimer may vary by region, and readership should consult manufacturer instructions for use to assure proper use of the assay. In this chapter, several methods for measuring D-dimer will be described.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution

Subscribe and save

Springer+ Basic
$34.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or eBook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Protocol
USD 49.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 219.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 199.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 279.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Similar content being viewed by others

Abbreviations

4PLC:

four-parameter logistic curve

CI:

confidence interval

CLIA:

chemiluminescent immunoassay

CLSI:

Clinical and Laboratory Standards Institute

CV:

coefficient of variation

DDi:

D-dimer

DEA:

diethanolamine

DIC:

disseminated intravascular coagulation

DVT:

deep vein thrombosis

EDTA:

ethylenediaminetetraacetic acid

ELFA:

enzyme-linked immunosorbent fluorescent assay

ELISA:

enzyme-linked immunosorbent assay

FbDP:

fibrin degradation products

FDP:

fibrin(ogen) degradation products

FEU:

fibrinogen equivalent unit

HAMA:

human anti-mouse antibodies

HCV:

hepatitis C virus

HIV:

human immunodeficiency virus

ID:

identification

IFU:

instructions for use

IU:

international units

LIA:

latex immunoassay

MLE:

Master Lot Entry

NPV:

negative predictive value

PC:

control line or control zone

PE:

pulmonary embolism

POC:

point of care

PPP:

platelet-poor plasma

PTP:

pretest probability

RFV:

relative fluorescence value

RLUs:

relative light units

SPR:

Solid Phase Receptacle

T:

test line or test zone

TMB:

tetramethylbenzidine

VTE:

venous thromboembolism

References

  1. Horan JT, Francis CW (2001) Fibrin degradation products, fibrin monomer and soluble fibrin in disseminated intravascular coagulation. Semin Thromb Hemost 27:657–666

    Article  CAS  PubMed  Google Scholar 

  2. Ratky SM, Martin MJ, Gordon YB, Baker LRI, Leslie J, Chard T (1975) A comparison between radioimmunoassay and other immunological techniques for the measurement of fibrinogen/fibrin degradation products in serum. Brit J of Haematol 30:145–149

    Article  CAS  Google Scholar 

  3. Cooke ED, Bowcock SA, Pilcher MF, Ibbotson RM, Gordon YB, Sola CM et al (1975) Serum fibrin(ogen) degradation products in diagnosis of deep-vein thrombosis and pulmonary embolism after hip surgery. Lancet 12;2(7924):51–54

    Article  Google Scholar 

  4. Clinical and Laboratory Standards Institute (CLSI) (2011) Quantitative D-dimer for the exclusion of venous thromboembolic disease; approved guideline. CLSI document H59-A. CLSI, Wayne

    Google Scholar 

  5. Suzuki K, Wada H, Imai H, Iba T, Thachil J, Toh CH; Subcommittee on Disseminated Intravascular Coagulation (2018) A re-evaluation of the D-dimer cut-off value for making a diagnosis according to the ISTH overt-DIC diagnostic criteria: communication from the SSC of the ISTH. J Thromb Haemost 16(7):1442–1444

    Google Scholar 

  6. Johnson ED, Schell JC, Rodgers GM (2019) The D-dimer assay. Am J Hematol 94:833–839

    PubMed  Google Scholar 

  7. Kearon C, Akl EA (2014) Duration of anticoagulant therapy for deep vein thrombosis and pulmonary embolism. Blood 123:1794–1801

    Article  CAS  PubMed  Google Scholar 

  8. Rodger MA, Le Gal G, Anderson DR, Schmidt J, Pernod G, Kahn SR, et al; REVERSE II Study Investigators (2017) Validating the HERDOO2 rule to guide treatment duration for women with unprovoked venous thrombosis: multinational prospective cohort management study. BMJ 356:j1065

    Google Scholar 

  9. Kearon C, Kahn SR (2020) Long-term treatment of venous thromboembolism. Blood 135:317–325

    Article  PubMed  Google Scholar 

  10. Thachil J, Juffermans NP, Ranucci M, Connors JM, Warkentin TE, Ortel TL, Levi M, Iba T, Levy JH (2020) ISTH DIC subcommittee communication on anticoagulation in COVID-19. J Thromb Haemost 18:2138–2144

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. Schouten HJ, Geersing GJ, Koek HL, Zuithoff NP, Janssen KJ, Douma RA et al (2013) Diagnostic accuracy of conventional or age adjusted D-dimer cut-off values in older patients with suspected venous thromboembolism: systematic review and meta-analysis. BMJ 3(346):f2492

    Article  Google Scholar 

  12. Righini M, Van Es J, Den Exter PL, Roy PM, Verschuren F, Ghuysen A et al (2014) Age-adjusted D-dimer cutoff levels to rule out pulmonary embolism: the ADJUST-PE study. JAMA 311:1117–1124

    Article  CAS  PubMed  Google Scholar 

  13. Wells PS, Anderson DR, Bormanis J, Guy F, Mitchell M, Gray L et al (1999) Application of a diagnostic clinical model for the management of hospitalized patients with suspected deep-vein thrombosis. Thromb Haemost 81:493–497

    Article  CAS  PubMed  Google Scholar 

  14. Wells PS, Anderson DR, Rodger M, Ginsberg JS, Kearon C, Gent M et al (2000) Derivation of a simple clinical model to categorize patients probability of pulmonary embolism: increasing the models utility with the SimpliRED D-dimer. Thromb Haemost 83:416–420

    Article  CAS  PubMed  Google Scholar 

  15. Gosselin RC, Owings JT, Kehoe J, Anderson JT, Dwyre DM, Jacoby RC et al (2003) Comparison of six D-dimer methods in patients suspected of deep vein thrombosis. Blood Coagul Fibrinolysis 14:545–550

    Article  CAS  PubMed  Google Scholar 

  16. Longstaff C, Adcock D, Olson JD, Jennings I, Kitchen S, Mutch N et al (2016) Harmonisation of D-dimer – a call for action. Thromb Res 137:219–220

    Article  CAS  PubMed  Google Scholar 

  17. Thachil J, Longstaff C, Favaloro EJ, Lippi G, Urano T, Kim PY; SSC Subcommittee on Fibrinolysis of the International Society on Thrombosis and Haemostasis (2020) The need for accurate D-dimer reporting in COVID-19: communication from the ISTH SSC on fibrinolysis. J Thromb Haemost 18:2408–2411

    Article  Google Scholar 

  18. Lippi G, Favaloro EJ (2020) D-dimer measurement in COVID-19: silver bullet or clinical distraction? Thromb Res 196:635–637

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  19. HemosIL™ D-Dimer HS Instructions for Use. Product 0020007700; revision 5; April 2010. Instrumentation Laboratory, Medford

    Google Scholar 

  20. HemosIL® D-Dimer 500 Instructions for Use. Product 0020301000; revision 3; February 2017. Instrumentation Laboratory, Medford

    Google Scholar 

  21. Olson JD, Cunningham MT, Higgins RA, Eby CS, Brandt JT (2013) D-dimer: simple test, tough problems. Arch Pathol Lab Med 137:1030–1038

    Article  CAS  PubMed  Google Scholar 

  22. Clinical and Laboratory Standards Institute (CLSI) (2008) Collection, transport, and processing of blood specimens for testing plasma-based coagulation assays and molecular hemostasis assays; Approved guideline – fifth edition. CLSI document H21-A5. CLSI, Wayne

    Google Scholar 

  23. Gosselin RC, Marlar RA (2019) Preanalytical variables in Coagulation testing: setting the stage for accurate results. Semin Thromb Hemost 45:433–448

    Article  PubMed  Google Scholar 

  24. Asserachrom® D-Di Instructions for use. Product 00947; July 2015. Diagnostica Stago, Asnières sur Seine, France

    Google Scholar 

  25. Vidas® D-Dimer Exclusion II™ (DEX2) Instructions for Use. Product #30 455. Revision B, Jun 2011. bioMérieux SA. Marcy-l’Etoile, France

    Google Scholar 

  26. STA® – Liastest® D-Di U.S. Instructions for Use. U.S. Specific package insert. (Product # 00515). Jan 2017. Diagnostica Stago, Asnières sur Seine, France

    Google Scholar 

  27. HemosIL® AcuStar D-Dimer Instructions for Use (Product 0009802000). Revision 7, Nov 2016. Instrumentation Laboratory, Bedford MA

    Google Scholar 

  28. Clinical and Laboratory Standards Institute (CLSI). (2006) Preparation and testing of reagent water in the clinical laboratory. Approved guideline, 4th Edition CLSI document C3-A4. CLSI, Wayne, PA

    Google Scholar 

  29. D-dimer Rapid Test Cassette Package insert. Home Health UK. Number 145638302. Effective date: 2018-05-17

    Google Scholar 

  30. HemosIL® AcuStar™ D-Dimer Controls Instructions for Use. (Product #0009802100). Revision 7, Dec 2016. Instrumentation Laboratory, Bedford MA

    Google Scholar 

  31. Favaloro EJ, Chapman K, Mohammed S, Vong R, Pasalic L (2023) Automated and rapid ADAMTS13 testing using chemiluminescence: utility for identification or exclusion of TTP and beyond. In: Favaloro EJ, Gosselin RC (eds) Hemostasis and thrombosis: methods and protocols. Methods in molecular biology. Springer, Cham, pp 487–504. 10.1007/978-1-0716-3175-1_32

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. University of California, Davis Health System, Thrombosis & Hemostasis Center, Sacramento, CA, USA

    Robert C. Gosselin

Authors
  1. Robert C. Gosselin
    View author publications

    You can also search for this author in PubMed Google Scholar

Editor information

Editors and Affiliations

  1. School of Medical Sciences, Faculty of Medicine and Health University of Sydney, Westmead Hospital, Westmead, NSW, Australia

    Emmanuel J. Favaloro

  2. Hemostasis & Thrombosis Center, University of California, Davis, Sacramento, CA, USA

    Robert C. Gosselin

Rights and permissions

Reprints and permissions

Copyright information

© 2023 The Author(s), under exclusive license to Springer Science+Business Media, LLC, part of Springer Nature

About this protocol

Check for updates. Verify currency and authenticity via CrossMark

Cite this protocol

Gosselin, R.C. (2023). Protocols for D-Dimer Measurements for Aid to Diagnosis or Exclusion of Venous Thromboembolism. In: Favaloro, E.J., Gosselin, R.C. (eds) Hemostasis and Thrombosis. Methods in Molecular Biology, vol 2663. Humana, New York, NY. https://doi.org/10.1007/978-1-0716-3175-1_8

Download citation

  • DOI: https://doi.org/10.1007/978-1-0716-3175-1_8

  • Published:

  • Publisher Name: Humana, New York, NY

  • Print ISBN: 978-1-0716-3174-4

  • Online ISBN: 978-1-0716-3175-1

  • eBook Packages: Springer Protocols

Publish with us

Policies and ethics

Search

Navigation