Line Immuno Assay (LIA) for the Detection of Antibodies in Autoimmune Vasculitis

Primary DI

06924030400972

Basic UDI-DI Code

B-06924030400972

Reference

MB00177

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

HOB Biotech Group Corp., Ltd.

The HOB-LIA-Vasculitis is for the qualitative measurement of IgG class antibodies against PR3, MPO and GBM in human serum. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of systemic vasculitis, i.e. Wegener’s granulomatosis, and the Goodpasture syndrome. Proteinase 3 (PR3) is the main target of cytoplasmic anti-neutrophil cytoplasm antibodies (cANCA). In contrast to that, perinuclear ANCA (pANCA) mainly react with myeloperoxidase (MPO). cANCA are closely related to Wegener's granulomatosis classically causing severe glomerulonephritis. Repeated examination for cANCA is therefore of value for monitoring of disease activity and effect of treatment. pANCA, detected by indirect immunofluorescence, can also be found in a lot of diseases apart from vasculitis. Consequently the detection of cANCA and pANCA by indirect immune fluorescence is not sufficient to proof systemic necrotising vasculitis. Therefore it is necessary to analyze the fine specification of PR3-ANCA and MPO-ANCA by ELISA as a second step or in parallel. Anti-GBM antibodies (anti-glomerular basement membrane antibodies) can be detected in about 90% of patients with Goodpasture's syndrome. While Goodpasture's syndrome is a relatively rare condition (0.5% of all patients with renal diseases), it is rapidly progressive and, if not treated, fatal in 75-90%. An early diagnosis and an immediate and correct treatment decrease the lethality dramatically.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).