Keywords
How to Cite
Abstract
The aim of this study was to evaluate the correlation of D-Dimer (DD) results obtained in a series of samples from COVID-19 patients by 4 methods used in 3 laboratories. Population: 39 consecutive patients with positive rt-PCR for COVID-19, admitted to Hospital Universitario Austral (HUA) and Hospital Solidario COVID Austral, in October 2020; 22 men and 17 women. Age: 12-82 years, with an average of 52 years. The 46 citrated plasma samples obtained were immediately processed in center 1 (HUA), aliquoted and frozen at -70 ° C for their referral to the other centers. Determination of DD: Center 1: VIDAS® DEX2, VIDAS 3 unit (BioMérieux) (Method A). Center 2: Innovance D-dimer, in CS 2500 (Siemens) (Method B). In center 3, they were processed by Liatest DDi plus, in STA Compact Max (Stago) (Method C) and by HemosIL D dimer, in ACL TOP 500 (Instrumentation Laboratory) (Method D). The EP Evaluator® was used for statistical analysis: comparison of multiple instruments and comparison of 2 instruments. The levels of DD found for method A: mean 3833 ng / ml FEU (range: 170-34390); method B: mean: 4567 ng / ml FEU (180-36910); method C: mean: 3916 ng / ml FEU (189-28520); method D: mean: 3429 ng / ml FEU (230-15046) (the result obtained in DD units was converted to FEU units using a conversion factor of 2). The multiple instrument comparison test, using a Total Allowable Error (TEa) of 34.53%, calculated by minimal biological variability for method A (considered as reference), showed that the different methodologies were not comparable. When comparing each of the methodologies B, C and D vs A, the comparison VIDAS® DEX2 vs Liatest DDi plus showed a correlation coefficient: (R) 0.9501, slope: 0.941 (0.850-1.031), intercept: 310, 1 (-375.5-995.8). The rest of the comparisons showed correlation coefficients less than 0.86. Although there was an 80% (37/46) agreement between the different methodologies when comparing patients with values greater than cut off (500 ng / ml FEU), the proportion of the increase in DD with respect to the upper limit of normal (ULN) was different for each method. Therefore, in our series of COVID-19 patient samples, the 4 methods for the quantitative determination of DD are not comparable, coinciding with what is described in the bibliography for other pathologies. For this reason, absolute or ULN cutoff values should not be extrapolated between the different methods.
References
Linkins LA, Takach Lapner S. Review of D-dimer testing: Good, Bad, and Ugly. Int J Lab Hematol. 2017 May;39 Suppl 1:98-103.
Johnson ED, Schell JC, Rodgers GM. The D-dimer assay. Am J Hematol. 2019 Jul;94(7):833-839.
Duboscq C, Ceresetto J, Martinuzzo M y col. Uso y limitaciones del dímero D en la exclusión del tromboembolismo venoso. Hematología. 2019; 22(1), 55-65.
Privitera V, Rosa C. Dímero-D en COVID-19: utilidad clínica y costo-efectividad. Hematología. 2021;25(Número Extraordinario XXV Congreso Argentino de Hematología):321-333.
Dempfle CE. Validation, calibration, and specificity of quantitative D-dimer assays. Semin Vasc Med. 2005 Nov;5(4):315-20.
Meijer P, Kluft C. The harmonization of quantitative test results of different D-dimer methods. Semin Vasc Med. 2005 Nov;5(4):321-7.
Longstaff C, Adcock D, Olson JD, Jennings I, Kitchen S, Mutch N, Meijer P, Favaloro EJ, Lippi G, Thachil J. Harmonisation of D-dimer - A call for action. Thromb Res. 2016 Jan;137:219-220.
CLSI Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease, approved guidelines 1st Edition, CLSI documents H59 A Wayne PA: Clinical Laboratory Standards Institute 2011.
Lippi G, Plebani M. Laboratory abnormalities in patients with COVID-2019 infection. Clin Chem Lab Med. 2020 Jun 25;58(7):1131-1134.
Guan WJ, Ni ZY, Hu Y y col; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720.
Bao J, Li C, Zhang K, Kang H, Chen W, Gu B. Comparative analysis of laboratory indexes of severe and non-severe patients infected with COVID-19. Clin Chim Acta. 2020 Oct;509:180-194.
Lippi G, Favaloro EJ. D-dimer is Associated with Severity of Coronavirus Disease 2019: A Pooled Analysis. Thromb Haemost. 2020 May;120(5):876-878.
Zhou F, Yu T, Du R y col. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. Erratum in: Lancet. 2020 Mar 28;395(10229):1038.
Zhang L, Yan X, Fan Q, Liu H, Liu X, Liu Z, Zhang Z. D-dimer levels on admission to predict in-hospital mortality in patients with Covid-19. J Thromb Haemost. 2020 Jun;18(6):1324-1329.
Moreno G, Carbonel R, Bodí M, Rodríguez A. Revisión sistemática sobre la utilidad pronóstica del dímero-D, coagulación intravascular diseminada y tratamiento anticoagulante en pacientes graves con COVID-19. Med Intensiva. 2020. https://doi.org/10.1016/j.medin.2020.06.006.
Lodigiani C, Iapichino G, Carenzo L y col; Humanitas COVID-19 Task Force. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy.
Thromb Res. 2020 Jul;191:9-14.
Berger JS, Kunichoff D, Adhikari S y col. Prevalence and Outcomes of D-Dimer Elevation in Hospitalized Patients With COVID-19. Arterioscler Thromb Vasc Biol. 2020 Oct;40(10):2539-2547.
Thachil J, Tang N, Gando S y col. ISTH interim guidance on recognition and management of coagulopathy in COVID-19. J Thromb Haemost. 2020 May;18(5):1023-1026.
Nopp S, Moik F, Jilma B, Pabinger I, Ay C. Risk of venous thromboembolism in patients with COVID-19: A systematic review and meta-analysis. Res Pract Thromb Haemost. 2020 Sep 25;4(7):1178-91.
Nauka PC, Baron SW, Assa A y col. Utility of D-dimer in predicting venous thromboembolism in non-mechanically ventilated COVID-19 survivors. Thromb Res. 2021 Mar;199:82-84.
Spyropoulos AC, Levy JH, Ageno W y col; Subcommittee on Perioperative, Critical Care Thrombosis, Haemostasis of the Scientific, Standardization Committee of the International Society on Thrombosis and Haemostasis. Scientific and Standardization Committee commu-nication: Clinical guidance on the diagnosis, prevention, and treatment of venous thromboembolism in hospitalized patients with COVID-19. J
Thromb Haemost. 2020 Aug;18(8):1859-1865.
Kogan AE, Mukharyamova KS, Bereznikova AV, Filatov VL, Koshkina EV, Bloshchitsyna MN, Katrukha AG. Monoclonal antibodies with equal specificity to D-dimer and high-molecular-weight fibrin degradation products. Blood Coagul Fibrinolysis. 2016 Jul;27(5):542-50.
All material published in the journal HEMATOLOGÍA (electronic and print version) is transferred to the Argentinean Society of Hematology. In accordance with the copyright Act (Act 11 723), a copyright transfer form will be sent to the authors of approved works, which has to be signed by all the authors before its publication. Authors should keep a copy of the original since the journal is not responsible for damages or losses of the material that was submitted. Authors should send an electronic version to the email: revista@sah.org.ar