2,268
Views
7
CrossRef citations to date
0
Altmetric
Original Articles

Analytical performance and user-friendliness of five novel point-of-care D-dimer assays

ORCID Icon, , , , &
Pages 433-440 | Received 22 Jan 2020, Accepted 10 May 2020, Published online: 27 May 2020

References

  • Huerta C, Johansson S, Wallander MA, et al. Risk factors and short-term mortality of venous thromboembolism diagnosed in the primary care setting in the United Kingdom. Arch Intern Med. 2007;167(9):935–943.
  • Naess IA, Christiansen SC, Romundstad P, et al. Incidence and mortality of venous thrombosis: a population-based study. J Thromb Haemost. 2007;5(4):692–699.
  • Kearon C. Natural history of venous thromboembolism. Circulation. 2003;107(90231):22I–230.
  • Meyer G, Roy PM, Gilberg S, et al. Pulmonary embolism. BMJ. 2010;340(apr13 2):c1421–c1421.
  • Oudega R, Moons KG, Hoes AW. Limited value of patient history and physical examination in diagnosing deep vein thrombosis in primary care. Fam Pract. 2005;22(1):86–91.
  • Schiff GD, Hasan O, Kim S, et al. Diagnostic error in medicine: analysis of 583 physician-reported errors. Arch Intern Med. 2009;169(20):1881–1887.
  • Bates SM, Jaeschke R, Stevens SM, et al. Diagnosis of DVT: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2):e351S–e2299.
  • Buller HR, Ten Cate-Hoek AJ, Hoes AW, et al. Safely ruling out deep venous thrombosis in primary care. Ann Intern Med. 2009;150(4):229–235.
  • Geersing GJ, Erkens PM, Lucassen WA, et al. Safe exclusion of pulmonary embolism using the Wells rule and qualitative D-dimer testing in primary care: prospective cohort study. BMJ. 2012;345:e6564.
  • Deep vein thrombosis (DVT): Diagnosis. Thrombosis Canada; 2017. http://thrombosiscanada.ca/wp-content/uploads/2017/05/Deep-Vein-Thrombosis-Diagnosis-2017May16-Final.pdf
  • Lim W, Le Gal G, Bates SM, et al. American Society of Hematology 2018 guidelines for management of venous thromboembolism: diagnosis of venous thromboembolism. Blood Adv. 2018;2(22):3226–3256.
  • NHG-werkgroep Diepe veneuze trombose en longembolie. NHG-Standaard Diepe veneuze trombose en longembolie (tweede partiële herziening). Huisarts Wet 2017;60(9):460.
  • Tran HA, Gibbs H, Merriman E, et al. New guidelines from the Thrombosis and Haemostasis Society of Australia and New Zealand for the diagnosis and management of venous thromboembolism. Med J Aust. 2019;210(5):227–235.
  • Oudega R, Moons KG, Hoes AW. Ruling out deep venous thrombosis in primary care. A simple diagnostic algorithm including D-dimer testing. Thromb Haemost. 2005;94(1):200–205.
  • van Belle A, Buller HR, Huisman MV, et al. Effectiveness of managing suspected pulmonary embolism using an algorithm combining clinical probability, D-dimer testing, and computed tomography. JAMA. 2006;295(2):172–179.
  • Saltro Diagnostic Centre. Communiqué of the Dutch Society of Clinical Biochemistry. Utrecht, the Netherlands; 2014.
  • Aguilar C, Sartori M, D'Angelo A, et al. Validation of the STA-Liatest DDi assay for exclusion of proximal deep vein thrombosis according to the latest Clinical and Laboratory Standards Institute/Food and Drug Administration guideline: results of a multicenter management study. Blood Coagul Fibrinolysis. 2018;29(6):562–566.
  • Kline JA, Hogg MM, Courtney DM, et al. D-dimer threshold increase with pretest probability unlikely for pulmonary embolism to decrease unnecessary computerized tomographic pulmonary angiography. J Thromb Haemost. 2012;10(4):572–581.
  • CLSI. Document EP05-A2: Evaluation of precision performance of quantitative measurement methods; approved guideline. 2nd ed.; 2004.
  • Michinela J, Ricós C, Perich C, et al. Biological variation database and quality specifications for imprecision, bias and total error (desirable and minimum). The 2014 update. Westgard QC; 2014. https://www.westgard.com/biodatabase1.htm
  • Antovic JP, Hoog Hammarstrom K, Forslund G, et al. Comparison of five point-of-care D-dimer assays with the standard laboratory method. Int J Lab Hematol. 2012;34(5):495–501.
  • Kallner A, McQueen M, Heuck C. The Stockholm Consensus Conference on quality specifications in laboratory medicine, 25–26 April 1999. Scand J Clin Lab Invest. 1999;59(7):475–476.
  • Bilic-Zulle L. Comparison of methods: passing and Bablok regression. Biochem Med. 2011;21:49–52.
  • Wayne P. Clinical and Laboratory Standards Institute (CLSI). Method comparison and bias estimation using patient samples; approved guideline. CLSI; 1992 (CLSI Document EP9-A).
  • Bland JM, Altman DG. Comparing methods of measurement: why plotting difference against standard method is misleading. Lancet. 1995;346(8982):1085–1087.
  • Dewitte K, Fierens C, Stockl D, et al. Application of the Bland-Altman plot for interpretation of method-comparison studies: a critical investigation of its practice. Clin Chem. 2002;48(5):799–801.
  • Brooke J. SUS: a ‘quick and dirty’ usability scale. In: Usability evaluation in industry. London: Taylor and Francis; 1996, p. 189–194.
  • Klug B. An overview of the system usability scale in library website and system usability testing. Weave J Libr User Experience. 2017;1(6):1.
  • Oude Elferink RF, Loot AE, Van De Klashorst CG, et al. Clinical evaluation of eight different D-dimer tests for the exclusion of deep venous thrombosis in primary care patients. Scand J Clin Lab Invest. 2015;75(3):230–238.
  • Fukuda T, Kasai H, Kusano T, et al. A rapid and quantitative D-Dimer assay in whole blood and plasma on the point-of-care PATHFAST analyzer. Thromb Res. 2007;120(5):695–701.
  • Sen B, Kesteven P, Avery P. Comparison of D-dimer point of care test (POCT) against current laboratory test in patients with suspected venous thromboembolism (VTE) presenting to the emergency department (ED). J Clin Pathol. 2014;67(5):437–440.
  • Spanuth E, Ivandic B, Thomae R, et al. Comparison of the PATHFAST D-dimer assay with two POC D-dimer assays. Crit Care. 2015;19(Suppl 1):P321.
  • von Lode P, Rainaho J, Laiho MK, et al. Sensitive and quantitative, 10-min immunofluorometric assay for D-Dimer in whole blood. Thromb Res. 2006;118(5):573–585.
  • Geersing GJ, Toll DB, Janssen KJ, et al. Diagnostic accuracy and user-friendliness of 5 point-of-care D-dimer tests for the exclusion of deep vein thrombosis. Clin Chem. 2010;56(11):1758–1766.
  • Minnaard MC, van de Pol AC, Broekhuizen BD, et al. Analytical performance, agreement and user-friendliness of five C-reactive protein point-of-care tests. Scand J Clin Lab Invest. 2013;73(8):627–634.
  • Schot MJ, van Delft S, Kooijman-Buiting AM, et al. Analytical performance, agreement and user-friendliness of six point-of-care testing urine analysers for urinary tract infection in general practice. BMJ Open. 2015;5(5):e006857–006857.
  • Adam SS, Key NS, Greenberg CS. D-dimer antigen: current concepts and future prospects. Blood. 2009;113(13):2878–2887.
  • Skeie S, Thue G, Nerhus K, et al. Instruments for self-monitoring of blood glucose: comparisons of testing quality achieved by patients and a technician. Clin Chem. 2002;48(7):994–1003.
  • Ekelund S, Heilmann E. Comments on point of care D-dimer testing in the emergency department: a bioequivalence study. Ann Lab Med. 2014;34(1):64–65.