Laboratory Testing for ANCA-Associated Vasculitis
Confidence for Therapeutic Decisions

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Autoimmune-related vasculitis disorders can be life-threatening diseases involving inflammation of blood vessels. These include granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), which are associated with anti-neutrophil cytoplasmic antibodies (ANCA).1,2 In both diseases, life-threatening flares can occur that require immediate therapy.

Clinical and laboratory assessments are very important to provide a full picture of the disease and assist in identifying the specific type of vasculitis. The accurate diagnosis of vasculitis is crucial. Therapy is often aggressive, so ensuring the accurate diagnosis is pivotal for optimal patient outcomes.3,4  

 

Anti-glomerular basement membrane (GBM) disease, also known as Goodpasture’s disease, is a rare condition that causes inflammation of the capillary beds of the kidneys and lungs.5 Some patients with ANCA-associated vasculitis will also have GBM antibodies and differ in disease prognosis, depending on their anti-GBM level.2,4

Parallel testing of anti-PR3, anti-MPO, and anti-GBM is critical for differential diagnosis and rapid decisions on treatment of these commonly hospitalized patients.2  

 

Why choose Thermo Fisher Scientific as your partner for ANCA-associated vasculitis, Goodpasture syndrome and anti-GBM disease testing?

 

Best-in-class, fully automated testing for ANCA-associated vasculitis—putting the patient first.

EliA™ PR3S and EliA™ MPOS tests use innovative anchor technology to produce fully automated tests with the highest combination of specificity (98.0 % and 99.3%, respectively) and sensitivity (79.0% and 55.0%, respectively) on the market.6 Using the EliA™ ANCA-associated vasculitis portfolio enables your lab to help confidently differentiate diagnoses, and help ensure patients receive the correct treatment sooner.

 

100% specificity for Goodpasture syndrome and anti-GBM disease.7

Anti-GBM is a diagnostic marker for Goodpasture syndrome and anti-GBM disease, making specificity pivotal. EliA GBM test uses precise presentation of epitopes of the antigen, a human recombinant a3-chain of collagen type IV containing the NC1-domain.A study has shown that this gives the assay an exceptionally high specificity of up to 100% for Goodpasture syndrome and anti-GBM disease, with superior clinical performance to both indirect immune fluorescence on kidney tissue and an ELISA using purified GBM antigen.7 This leads to results you can trust to guide clinical decisions.

 

Lean workflow

Patients with ANCA-associated vasculitis may have anti-GBM antibodies and the other way round, many patients with Goodpasture syndrome / anti-GBM disease may have antibodies against MPO-ANCA.4 Using EliA™ tests for these diseases enables you to benefit from the efficiencies of performing all three relevant antibody tests, from one sample, in one run, on the same fully automated Phadia™ Laboratory Systems. With the random-access functionality, you can add tests as they arrive, thus minimizing turnaround time. You can also save time and costs by utilizing the monthly calibration per method and sharing common system reagents.

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References
  1. Bossuyt X, Rasmussen, N, van Paassen, P., Hellmich, B. et al. A multicentre study to improve clinical interpretation of proteinase-3 and myeloperoxidase anti-neutrophil cytoplasmic antibodies. Rheumatology 2017;56(9):1533-1541. 
  2. Damoiseaux J, Heijnen I, Van Campenhout C, Eriksson C et al. An international study on anti-neutrophil cytoplasmic antibodies (ANCA) testing in daily practice. Clin Chem Lab Med 2017; aop. 
  3. Solans-Laqué R, Fraile, G, Rodriguez-Carballeira, M, Caminal, L et al. Clinical characteristics and outcome of Spanish patients with ANCA-associated vasculitides: Impact of the vasculitis type, ANCA specificity, and treatment on mortality and morbidity. Medicine 2017;96(8): e6083. 
  4. McAdoo SP, Tanna A, Hruskova Z, Holm L et al. Patients double-seropositive for ANCA and anti-GBM antibodies have varied renal survival, frequency of relapse, and outcomes compared to single-seropositive patients. Kidney Int 2017; 92(3):693–7.
  5. McAdoo SP, Pusey CD. Anti-Glomerular Basement Membrane Disease. Clin J Am Soc Nephrol 2017; 12(7): 1162–1172.
  6. Thermo Fisher Scientific Internal Study, comparing EliA PR3S test and EliA MPOS test with 5 and 7 other methods, respectively. Sensitivity of EliA PR3S test calculated from 100 GPA sera; sensitivity of EliA MPOS test calculated from 80 MPA sera. Specificity of both tests calculated using 150 disease controls.
  7. Sinico R A, Radice A, Corace C, Sabadini E, Bollini B. Anti-glomerular basement membrane antibodies in the diagnosis of Goodpasture syndrome: a comparison of different assays. Nephrol Dial Transplant 2006;21 (2): 397–401.
  8. Directions for Use EliA GBM.