4259 – Anti-PR3 hs

Highlights

• Use of IgG antibodies against proteinase 3 (PR3)
• Ready-to-use (exception: wash buffer), color- and barcoded reagents
• Quality assured handling in routine laboratories
• Short incubation times (60 min / 30 min / 15 min) at room temperature
• Quantitative determination of IgG antibodies
• Supports diagnosis of systemic vasculitides (SV), including glomerulomatosis with polyangiitis (GPA)
• Correlation with the acuity of pancreatitis
• High sensitivity for PR3 antibodies, detecting conformational epitopes
• CE marked
• Automatable

Intended Purpose

The Anti-PR3 hs is a quantitative enzyme-linked immunosorbent assay (ELISA) for the determination of IgG antibodies against proteinase 3 (PR3) in human serum. The Anti-PR3 hs is intended as an aid in the diagnosis of systemic vasculitides (SV) in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Anti-neutrophil cytoplasmic antibodies (ANCA) play an important role in the serological diagnosis of SV. Researchers usually determine these antibodies by indirect immunofluorescence (IIF) using ethanol-fixed human neutrophils. The IIF pattern distinguishes cytoplasmic ANCA (cANCA) from perinuclear ANCA (pANCA). In IIF, reactivity against myeloperoxidase (MPO), a cationic protein located in azurophilic granules, mainly causes the pANCA pattern. MPO autoantibodies occur in a variety of vasculitides such as microscopic polyangiitis, Churg-Strauss syndrome and Polyarteritis nodosa. Autoantibodies to PR3 are a specific serological marker for Granulomatosis with Polyangiitis (GPA), especially the strong association of the titres with disease activity and the inhibition of the proteolytic activity of PR3.

Publications

• Xia et al., (2024) Loss of mucosal tolerance to glycoprotein 2 isoform 1 is a potential novel diagnostic biomarker for cholangiocarcinoma
• Lopens et al., (2022) PR3-ANCAs Detected by 3rd-Generation ELISA Predicts Severe Disease and Poor Survival in Primary Sclerosing Cholangitis
• Bossuyt et al., (2020) Standardisation of PR3-ANCA and MPO-ANCA_evaluation of certified reference materials
• Sowa et al., (2016) Simultaneous comprehensive multiplex Ab analysis for rapidly progressive glomerulonephritis
• Holle et al., (2012) Comparative analysis of different commercial ELISA systems for the detection of ANCAs in ANCA-associated vasculitides
• Knütter et al., (2012) Automated interpretation of ANCA patterns-a new approach in the serology of ANCA associated vasculitis
• Roggenbuck et al., (2009) High-sensitivity Detection of AutoAbs Against PR3 by a Novel Third-generation ELISA