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Research Articles

Abbott D-dimer assay: analytical performance and diagnostic accuracy in management of venous thromboembolism

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Pages 53-61 | Received 01 Aug 2023, Accepted 10 Feb 2024, Published online: 16 Feb 2024

References

  • ISTH Steering Committee for World Thrombosis Day. Thrombosis: a major contributor to the global disease burden. J Thromb Haemost. 2014;12:1580–1590.
  • Turpie AG, Chin BS, Lip GY. Venous thromboembolism: pathophysiology, clinical features, and prevention. BMJ. 2002;325(7369):887–890. doi: 10.1136/bmj.325.7369.887.
  • Jurić I, Nesek Adam V. Venous thromboembolism in the emergency department – single-center experience. Acta Clin Croat. 2022;61(Suppl. 1):44–48. doi: 10.20471/acc.2022.61.s1.07.
  • Ortel TL, Neumann I, Ageno W, et al. American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism. Blood Adv. 2020;4(19):4693–4738. doi: 10.1182/bloodadvances.2020001830.
  • Konstantinides SV, Meyer G, Becattini C, et al. 2019 ESC guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020;41(4):543–603. doi: 10.1093/eurheartj/ehz405.
  • Schulman S, Konstantinides S, Hu Y, et al. Venous thromboembolic diseases: diagnosis, management and thrombophilia testing: observations on NICE guideline [NG158]. Thromb Haemost. 2020;120(8):1143–1146. doi: 10.1055/s-0040-1712913.
  • Favresse J, Lippi G, Roy PM, et al. D-dimer: preanalytical, analytical, postanalytical variables, and clinical applications. Crit Rev Clin Lab Sci. 2018;55(8):548–577. doi: 10.1080/10408363.2018.1529734.
  • D-dimer for use with Alinity c. [package insert]. H25351R0Y, B1R10K. Abbott Laboratories, Chicago, USA; 2022.
  • Clinical and Laboratory Standards Institute (CLSI). Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline. 3rd ed. Wayne (PA): CLSI EP28-A3c; 2010.
  • Arai N, Collins A. Overview of a new D-dimer reagent innovance D-DIMER. Sysmex J Int. 2008;18:15–22.
  • INNOVANCE D-Dimer Calibrator. Certificate of traceability. D-01183. Siemens Healthcare Diagnostics Products GmbH, Marburg, Germany; 2017.
  • Clinical and Laboratory Standards Institute (CLSI). User verification of performance for precision and trueness; approved guideline. 2nd ed. Wayne (PA): CLSI EP15-A2; 2005.
  • Schouten HJ, Geersing GJ, Koek HL, et al. 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. 2013;346(1):f2492. doi: 10.1136/bmj.f2492.
  • Clinical and Laboratory Standards Institute (CLSI). User verification of precision and estimation of bias; approved guideline. 3rd ed. Wayne (PA): CLSI EP15-A3; 2014.
  • Aarsand AK, Fernandez-Calle P, Webster C, et al. The EFLM biological variation database; 2023 [cited 2023 Jun 28]. Available from: https://biologicalvariation.eu/
  • Lapić I, Coen Herak D, Prpić S, et al. Verification of automated latex-enhanced particle immunoturbidimetric D-dimer assays on different analytical platforms and comparability of test results. Biochem Med. 2020;30:030705.
  • La’ulu SL, Dominguez CM, Roberts WL. Performance characteristics of the AxSYM D-dimer assay. Clin Chim Acta. 2008;390(1–2):148–151. doi: 10.1016/j.cca.2008.01.019.
  • Park SJ, Chi HS, Chun SH, et al. Evaluation of performance including influence by interfering substances of the innovance D-dimer assay on the Sysmex coagulation analyzer. Ann Clin Lab Sci. 2011;41:20–24.
  • Salvagno GL, Lippi G, Montagnana M, et al. Performance of the automated and rapid HemosIL D-dimer HS on the ACL TOP analyzer. Blood Coagul Fibrinol. 2008;19(8):817–821. doi: 10.1097/MBC.0b013e32830f1bae.
  • Stegnar M, Bozic M. Determination of D-dimer by different quantitative assays – a harmonization exercise. Biochem Med. 2008;18:216–223. doi: 10.11613/BM.2008.022.
  • CLSI. Quantitative D-dimer for exclusion of venous thromboembolic disease. CLSI document H59-A. Wayne (PA): Clinical and Laboratory Standard Institute; 2011.
  • Di Nisio M, Squizzato A, Rutjes AWS, et al. Diagnostic accuracy of D-dimer test for exclusion of venous thromboembolism: a systematic review. J Thromb Haemost. 2007;5(2):296–304. doi: 10.1111/j.1538-7836.2007.02328.x.
  • Hamer HM, Stroobants AK, Bavalia R, et al. Diagnostic accuracy of four different D-dimer assays: a post-hoc analysis of the YEARS study. Thromb Res. 2021;201:18–22. doi: 10.1016/j.thromres.2021.02.003.
  • Legnani C, Cini M, Frascaro M, et al. Diagnostic accuracy of a new d-dimer assay (Sclavo Auto d-dimer) for exclusion of deep vein thrombosis in symptomatic outpatients. Clin Appl Thromb Hemost. 2017;23(3):221–228. doi: 10.1177/1076029616649436.
  • Lippi G, Bonfanti L, Saccenti C, et al. Causes of elevated D-dimer in patients admitted to a large urban emergency department. Eur J Intern Med. 2014;25(1):45–48. doi: 10.1016/j.ejim.2013.07.012.
  • Innocenti F, Lazzari C, Ricci F, et al. D-dimer tests in the emergency department: current insights. Open Access Emerg Med. 2021;13:465–479. doi: 10.2147/OAEM.S238696.
  • Lippi G, Perilli V. Has ‘'D-Dimeritis'’ worsened during the coronavirus 2019 pandemic? Semin Thromb Hemost. 2023;49(5):565–567. doi: 10.1055/s-0043-1761464.

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