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The BioPlex™ 2200 Vasculitis kit is a multiplex flow immunoassay intended for the semi-quantitative detection of IgG autoantibodies to Myeloperoxidase (MPO), Proteinase 3 (PR3) and Glomerylar Basement Membrane (GBM) in human serum. In conjunction with clinical findings, the test system is used as an aid in the diagnosis of anti-neutrophil cytoplasmic antibodies (ANCA)associated vasculitides: Microscopic Polyangitis (MPA), Necrotising Glomerulonephritis, Churg-Strauss Syndrome, Wegener's Granulomatosis and the autoimmune renal disorder, Goodpasture's syndrome. The BioPlex 2200 Vasculitis kit is intended for use with the Bio-Rad BioPlex 2200 System. The BioPlex 2200 Vasculitis Calibrator Set is intended for the calibration of the BioPlex 2200 Vasculitis Reagent Pack. The BioPlex 2200 Vasculitis Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Vasculitis Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Vasculitis Control Set has not been established with any other Vasculitis assays. The BioPlex 2200 Vasculitis kit is a multiplex flow immunoassav intended for the semiquantitative detection of IgG autoantibodies to Myeloperoxidase (MPO), serine proteinase 3 (PR3) and Glomerular Basement Membrane (GBM) in human serum. The BioPlex 2200 Vasculitis kit is intended for use with the Bio-Rad BioPlex 2200 System. Uses: The test system is used to detect the presence of antibodies in serum samples, as an aid in the diagnosis of certain autoimmune vasculitides such as Microscopic Polyangilitis (MPA), Necrotising Glomerulonephritis, Churg-Strauss Syndrome, Wegener's Granulomatosis and autoimmune renal disorders, such as Goodpasture's syndrome, in conjunction with clinical findings and other laboratory tests.

The Vasculitis kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube. Three (3) different populations of beads are coated with antigens associated with vasculitis disease (MPO, PR3 and GBM). The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, antibody, conjugated to phycoerythin (PE), is added to the dyed beads and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity (RFI), Three additional dyed beads, an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma. Refer to the BioPlex 2200 System Operation Manual for more information. The instrument is calibrated using a set of four (4) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. A combination of four (4) vials representing four (4) different antibody concentrations are used for semi-quantitative calibration. The result for each of these antibodies is expressed as an antibody index (Al).

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to glomerular basement membrane(GBM) in human serum. The results of the anti-GBM assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-GBM antibodies including Goodpastures Syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. For in vitro diagnostic use only.

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to GBM in human serum. This device is designed for use with the Hycor Hy•Tec Automated EIA instrument.

For the in-vitro measurement of specific IgG autoantibodies against the glomerular basement membrane (GBM) specifically the C-terminal end of type IV collagen, present in human serum. It is intended as an aid in the diagnosis of Goodpast's syndrome, in conjunction with other clinical findings.

BINDAZYME Anti-GBM EIA Diagnostic Test Kit

A semiquantitative enzyme linked immunosorbant assay (ELISA) detecting IgG class autoantibody to glomerular basement membrane (GBM) in human serum. This test is an aid in the diagnosis of autoimmune renal disorders such as Goodpasture's syndrome.

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