The Wieslab® Anti-GBM, ANCA Screening Test Kit is an ELISA for the qualitative detection of antibodies to glomerular basement membrane (GBM), Proteinase-3 (PR3) and Myeloperoxidase (MPO) in human sera.
The assay is used to detect antibodies in a single serum specimen and the results of the assay are to be used as an aid to the diagnosis of reno-pulmonary syndromes and rapidly progressive glomerulonephritis, especially Goodpasture syndrome (GP), Wegener’s granulomatosis (WG) (granulomatosis with polyangiitis) and microscopic polyangiitis (MP).
The assay is intended for use in patients with signs and symptoms consistent with GP, WG, and MP. It is not intended for screening a healthy population.
|Assay target||GBM antibodies|
|Read-out of results||Qualitative,|
|Assay time||40 min|
|Detection system||ALP/pNPP read at 405 nm|
|Regulatory status||IVD, CE labeled, 510(k) FDA|
All reagents in the kit are ready for use except wash solution and and should be stored at + 2-8 ° C.
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