4123 – AKLIDES® Anti-GBM

Intended Purpose

The AKLIDES® Anti-GBM is an immunofluorescence assay (IFA) for the qualitative determination of IgG antibodies in human serum against glomerular basement membrane antigens on monkey kidney tissue sections. The AKLIDES® Anti-GBM is intended as an aid in the diagnosis of autoimmune glomerulonephritides in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual processing and automated imaging using the AKLIDES® or akiron® system. The immunoassay is designed for professional in vitro diagnostic use.

Diagnostic Relevance

Goodpasture syndrome, an autoimmune kidney disorder, is characterized by the coexistence of proliferative glomerulonephritis with lung haemorrhage and the formation of anti-GBM antibodies. Detection of the pathogenic circulating autoantibodies to GBM is a key diagnostic parameter of Goodpasture syndrome. The GBM is an anatomical barrier between kidney epithelia and connective tissue and plays an important role in ultrafiltration. Rapid progressive glomerulonephritis (RPGN) is a common feature of many autoimmune disorders. Differential diagnosis of autoimmune nephritides requires the determination of antibodies to GBM together with the determination of antibodies to neutrophilic cytoplasmic antigens (ANCA, characteristic for Wegener’s disease and vasculitis-associated RPGN), and nuclear antibodies (ANA, characteristic for lupus nephritis).

Product Specifications

Product code 4123
Indication Autoimmune glomerulonephritides
Description Indirect immunofluorescence assay for the determination of IgG antibodies in human serum against smooth muscle
Format Slides coated with cryostat tissue sections of monkey kidney
Incubation time 60 min.
Sample volume 50 µL serum
No. of determinations 48 (12 x 4)

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.