4123 – AKLIDES® Anti-GBM

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.

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).

 The IFA (indirect immunofluorescence assay) is an immunoassay for the determination of specific antibodies. Tissue sections or cells containing the antigen of interest are immobilized on slides. If specific antibodies are present in the patient´s sample, they bind to the antigen in the tissue. A secondary antibody conjugated with fluorescein-isothiocyanat (FITC) detects the generated immune complex. The slides are examined using a fluorescence microscope. A specific fluorescent staining pattern demonstrates the presence of specific antibodies in the patient´s sample.

 The immunoassay is designed for manual processing and automated imaging using the AKLIDES® or akiron® system.

Worldwide first and fully automated system, AKLIDES® digital fluorescence microscope is used for the standardized imaging and data processing in immunofluorescence tests on glass slides. Controlled by the AKLIDES® Software, the AKLIDES® system has the ability to produce valid standardized analyses and to document immunofluorescence assays electronically to augment daily laboratory routine in the diagnosis of autoimmune diseases.

The immunoassay is designed for professional in vitro diagnostic use.