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Sponsored: EliA rheumatic disease tests


30 October, 2019  

Best-in-class diagnostics that make a measurable difference to the management of patients with rheumatic diseases

The challenge of the rheumatic disease patient

The often-vague and overlapping symptoms of early rheumatic disease can make differentiation challenging,1 leading to an average time to diagnosis of 6-42 months, disease dependent.2-8 Delays in diagnosis are associated with poorer patient outcomes,9-17 so clinically relevant, reliable testing is vital from the beginning. Since rheumatic disease patients carry an increased risk of comorbidities, including other autoimmune conditions, cardiovascular disease and malignancy,18-20 early intervention is key.21-25

Early, accurate diagnosis can help reduce the burden on the healthcare system

When patients suffer from non-specific symptoms such as fatigue and arthralgia, tests for anti-nuclear antibodies (ANA) by indirect immunofluorescence or solid phase ANA screens, anti-cyclic citrullinated peptide (anti-CCP) antibodies, and rheumatoid factor (RF) are commonly requested.26

However, testing is fallible; depending on the marker, 5-50% of these tests may provide false positive results. This can lead to further testing, avoidable referrals, misdiagnosis, inappropriate management, and even lawsuits.27-35 Given that up to 70% of medical decisions are based on results of testing for diagnostic markers,36-39 and that approximately 15% of medical cases in developed countries are misdiagnosed, leading to substantial costs,40-44 it is vital that test results are reliable.

When you get an EliATM test result, you can trust it to help you make the right clinical decision – leading to better patient outcomes

EliATM rheumatic disease tests* have been shown consistently to provide the most clinically accurate results, when compared with alternative tests,45-57 meaning:

  • The high sensitivity, even for difficult-to-detect autoantibodies such as Ro,58 ensures that you detect a comparable number of patients
  • The superior specificity of EliA rheumatic disease tests* minimises the number of false positives – potentially reducing avoidable investigations and treatment
  • You can correctly diagnose patients sooner, ensuring they receive the best management during the window of opportunity, and improving outcomes

What are the benefits of using EliATM tests? 

Outstanding quality

  • EliA best-in-class tests45-57
  • Results when you need them – PhadiaTM Laboratory Systems have outstanding reliability49
  • Proven reproducibility – demonstrated across >4,800 laboratory systems installed worldwide49

Cost savings

EliA tests support an early, accurate diagnosis, which can help to minimise:

  • Follow-up costs associated with misdiagnoses
  • Avoidable treatments
  • Avoidable emergency care
  • Risk of malpractice lawsuits

References

  1. The General Practice Guide to Autoimmune Diseases. P.L. SYaM, editor: Pabst Science Publishers, Lengerich Berlin; 2012
  2. Irvine S, et al. Ann Rheum Dis 1999;58:510–13.
  3. Gray M, Nuki J. Rheumatology (Oxford) 2001;40(Suppl 1):60. 23
  4. Jeyaratnam R, et al. Rheumatology (Oxford) 2001;40(Suppl 1):29.
  5. Potter T, et al. Rheumatology (Oxford) 2002;41:953–5; author reply 5.
  6. Raza K, et al. Ann Rheum Dis 2011;70:1822–5
  7. Rodriguez-Polanco E, et al. Rheumatol Int 2011;31:657–65.
  8. Nanji JA, et al. J Rheumatol 2012;39:707–11.
  9. Sørensen J, Lund Hetland M. Ann Rheum Dis. 2015; 74(3): e12.
  10. Raciborski F, et al. Rheumatologia. 2017; 55(4): 169–176.
  11. Cavagna L, et al. Medicine (Baltimore). 2016 95(39): e4827.
  12. Sjögren’s Syndrome Foundation, SSF Launches 5-Year Breakthrough Goal. 2012. Available at: http://www.sjogrens.org/home/about-the-foundation/breakthrough-goal-[Last accessed April 2019].
  13. Solans-Laqué R, et al. Semin Arthritis Rheum 2011; 41: 415-423.
  14. Gergianaki I, Bertsias G, Frontiers Medicine 2018; 5:161
  15. Lupus UK, People with lupus are waiting more than 6 years to get a diagnosis in the UK, 2018. Available at: //www.lupusuk.org.uk/six-year-diagnosis-delay/. [Last accessed July 2019.]
  16. Oglesby A, et al, Appl Health Econ Health Policy. 2014;12:179–90. doi: 10.1007/s40258-014-0085-x.
  17. Malik A, et al. Frontiers in Neurology 2016;7:64.
  18. Rua-Figueroa Inigo; Arthritis Care & research 2017;69(1):38-45.
  19. Fallahi P, et al. Front. Endocrinol. 8:266. doi: 10.3389/fendo.2017.00266.14.
  20. Caio G, et al. Gastroenterol Hepatol Bed Bench 2018;11(3):244-249.
  21.  Barhamain AS, et al. Open Access Rheumatol. 2017;9:139-50.
  22. Nell VPK, et al Ann Rheum Dis 2005;64 1731-1736
  23. Romao VC, et al. RMD Open. 2018;4(Suppl 1):e000789.
  24. Kuhn A, et al. Dtsch Arztebl Int. 2015;112(25):423-32.
  25. Saketkoo et al. Am J Med Sci. 2014; 347(1):doi:10.1097/MAJ.0b013e3182a55d24.
  26. Kavanaugh A, et al. Arch Pathol Lab Med 2000;124:71–8.
  27. Saber AS, et al. BMJ Qual Saf 2013;22:672-680.
  28. Suarez-Almazor ME. J. Rheumatology 1998;25(10):1980-5.
  29. Gamez-Nava JI, et al. British Journal of Rheumatology 1998;37:1215-1219.
  30. Gran JT, et al. Clinical Rheumatology 2000;19:(6) 450-4.
  31. Gonzáles-Buitrago M. Clin Chim Acta 2006;361 (1-2):50-7.
  32. Abeles AM, et al. The American Journal of Medicine 2013; 126: 342-348.
  33.  Fitch-Rogalsky C, et al. PLOS 2014;9 (4)1-8.
  34. Rasmussen A, et al. Rheumatology 2016.
  35. American College of Rheumatology, Position Statement on Methodology of Testing for Antinuclear Antibodies. Available at: https://www.rheumatology.org/Portals/0/Files/Methodology%20of%20Testing%… [Last accessed July 2019.]
  36. Badrick T, Clin Biochem Rev 2013;34: 43-6.
  37. Kruse-Jarres JD, Lab. Med 1994;18:21
  38. White paper diagnet, EDMA, 2010.
  39. Ulrich-Peter R, et al. PLoS One 2016; 11(3): e0149856.
  40. Leape L, et al. New England Journal of Medicine 1991; 324: 377-384.
  41. Singh H, et al. BMJ Qual Saf 2014;23:727–731.
  42. Newman-Toker D, et al. JAMA 2003;01:10
  43. The Telegraph, One in six NHS patients ‘misdiagnosed’. 2009. Available at: http://www.telegraph.co.uk/news/health/news/6216559/One-in-six-NHS-patie… [Last accessed July 2019.]
  44. Washington Post, Misdiagnosis is more common than drug errors or wrongsitesurgery. 2013. Available at: https://www.washingtonpost.com/national/health-science/misdiagnosis-is-m… 5d71a374-9af4-11e2-a941-a19bce7af755_story.html?utm_term=.31a433743084. [Last accessed July 2019.]
  45. Mathsson Alm L, et al. Clin Exp Rheumatol 2017; Nov 28 [Epub ahead of print].
  46. Nishimura K, et al. Ann Intern Med 2007; 146:797-808.
  47. Gonzalez C, et al. Clinica Chimica Acta 2005; 359: 109-114.editor: Pabst Science Publishers, Lengerich Berlin; 2012.
  48. Van der Pol P, et al. Clinica Chimica Acta 2018; 4 76: 154-159.
  49. ThermoFisher Scientific Internal Study
  50. Mascialino B, et al. Ann Rheum Dis 2018;77:1173.
  51. Korsholm T, et al. Scand J Rheumatol 2014;43:89.
  52. Robier C, et al. Clinical Chemistry and Laboratory Medicine 2016;54(8):1365-1370.
  53. Alpini C, et al. EliA Journal 2010 (Special Edition 1):3.
  54. Pereira LM, et al. EliA Journal 2010 (Special Edition 1):6-7.
  55. Otten HG, et al. Clin Exp Rheumatol 2017.
  56.  Jeong S, et al PLoS ONE 2017;12(3).
  57. Willems P, et al. Clin Chem Lab Med 2018; DOI: https://doi.org/10.1515/cclm-2017-0905 [epub ahead of print].
  58. Adebajo AO, et al. Collected reports on the rheumatic diseases. 2005. Available at: https://www.arthritisresearchuk.org/~/media/Files/Education/Hands-On/IP0… [Last accessed July 2019.]

*EliA rheumatic disease tests include: EliA CTD Screen, EliA SymphonyS, EliA CTD Single Parameters, EliA CCP, EliA RF isotypes, EliA Cardiolipin, EliA β2-Glycoprotein I, EliA PR3S, EliA MPOS , EliA GBM