It’s Great When There’s Something to Celebrate!
Last week we had such an occasion at ORGENTEC Diagnostika. The February issue of the Annals of the Rheumatic Diseases, the EULAR Journal, included the results of a clinical evaluation study of our Anti-PR3 hs ELISA. The results are very gratifying for us and reflected well on our product.
The subject of the article? – The effectiveness of our test for the diagnosis of ANCA-associated vasculitis, abbreviated as AAV. This term encompasses autoimmune diseases characterized by the presence of antineutrophil cytoplasmic antibodies, known as ANCA. These diseases include Wegener’s granulomatosis (WG), microscopic polyangiitis (MPA), and Churg-Strauss syndrome (CSS).
The authors of the current Letter in Ann Rheum Dis give our test a rating of “very good”. Their conclusion: “This study shows an excellent performance of PR3 hs ANCA ELISA in identifying AAV and other conditions known to be associated with PR3-ANCA. Based on these results, PR3 hs ANCA ELISA is a superior method for detecting PR3-ANCA and may be used as a screening test in patients with suspected systemic vasculitis in routine clinical practice, especially when WG is suspected.”
In addition, a prior study, which appeared in 2007 in the journal Clinical and Experimental Rheumatology, found that Anti-PR3 hs has a superior sensitivity of over 96% for the diagnosis of Wegener’s granulamatosis (WG). This high diagnostic sensitivity is reflected in the name of the test: hs stands for high sensitive!
How did our scientists achieve such a high sensitivity? It was made possible by a novel coating technique we use to anchor the PR3 antigen (PR3 stands for proteinase 3) in the wells of the microplate. The protein is immobilized by a bridging molecule, which leaves all relevant epitopes of the antigen accessible.
Author of this article: Tobias Stolzenberg
Holle JU, Csernok E, Fredenhagen G, Backes M, Bremer JP, Gross WL. Clinical Evaluation of hsPR3-ANCA ELISA for Detection of Antineutrophil Cytoplasmatic Antibodies Directed Against Proteinase 3. Ann Rheum Dis 2010;69:468-469 – doi:10.1136/ard.2009.109868 – abstract
Hellmich B, Csernok E, Fredenhagen G, Gross WL. A Novel High Sensitivity ELISA for Detection of Antineutrophil Cytoplasm Antibodies Against Proteinase-3. Clin Exp Rheumatol 2007;25(1 Suppl 44):S1-5 – abstract