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The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SS-A (60kDa and TRIM 21 (SS-A 52kDa)), SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosomes and centromere (CENP-B). (*Antibodies to dsDNA, Sm, Sm/RNP, SS-A, SS-B, Scl-70, Jo-1, ribosomes and CENP-B can be reported using this assay). Clinical utility: The results of the FIDIS™ CONNECTIVE 10 are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of connective diseases (systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis and CREST syndrome). FIDIS™ CONNECTIVE 10 kit uses serum only, and is to be run on the FIDIS™ Instrument and MLX-BOOSTER™ Software. FIDIS™ CONNECTIVE 10 kit may be used with the CARIS™ system (diluting and dispensing device). This kit is for In vitro diagnostic use.

FIDIS™ CONNECTIVE 10 kit is a multiplex flow immunoassay, which allows simultaneous identification and detection of several antibodies. FIDIS™ CONNECTIVE 10 is based on the use of distinct uniform size color-coded microsphere sets and a benchtop flow cytometer interfaced to digital signal processing hardware and software. A red diode laser beam in the flow cytometer recognizes each set of microspheres on the basis of its unique fluorescence intensity (red and infrared) thus identifying which parameter is being tested. At the same time, a green laser beam illuminates the external second molecule fluorescence to quantify the reaction related to the specific antigen. Ten different fluorescently "colored" sets of microspheres are coated with antigens associated with various connective diseases (dsDNA, SS-A (60kDA and TRIM 21 (SS-A 52kDa}}, SS-B, Sm, Sm/RNP, Scl-70, Jo-1, ribosomes and centromere). An additional microsphere (Internal Bead standard) set is coated with anti-IgG to ensure that false negative results due to operational error are detected. The eleven different sets of microspheres are mixed together. The mixture is lyophilized and constitutes the final microspheres reagent. The test is performed using a 96 wells microplate with a filtering membrane at the bottom of the wells. In the first step, the sample is distributed in each well containing the reconstituted microspheres mixture, allowing any anti-dsDNA; anti-SS-A (60kDa and TRIM 21 (SS-A 52kDa)), anti-SS-B, anti-Sm, anti-Sm/RNP, anti-Scl-70, anti-Io-1, anti-ribosomes and anti-centromere antibodies present to bind to the immobilized antigens on the microspheres, as well as free IgG to bind to the anti-IgG microsphere. After incubation, a wash step using a filtration process removes the unbound antibodies. A phycoerythrin anti-human IgG conjugate is then added that binds to the previously bound antibodies. A final wash step stops the reaction and eliminates the unbound conjugate. The reaction is then measured directly by the flow cytometer, which distinguishes each set of microspheres by its fluorescence color while simultaneously measuring the average fluorescence emitted by the conjugate. A calibration system allows the determination of the titer (AU/mL) of each sample by interpolation for each antigenic specificity.

The FIDIS™ VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticle immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of anti-neutrophil cytoplasmic antibodies (ANCA) directed against Myeloperoxidase (MPO), Serine Proteinase 3 (PR3) and antibodies directed against glomerular basement membrane (GBM) in human serum samples. The results of the FIDIS™ VASCULITIS* test are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of various primary systemic small blood vessel vasculitides and glomerular basement membrane disease. Clinical utility: The detection of ANCA is associated with primary systemic small blood vessel vasculitides: Wegener's granulomatosis, Churg Strauss syndromes, microscopic periarteritis and idiopathic crescentic glomerulonephritis; and the detection of anti-GBM antibodies is associated with Goodpasture's syndrome. FIDIS™ VASCULITIS* kit uses serum only, and is to be run on the FIDIS™ Instrument and MLX-BOOSTER Software. FIDIS™ VASCULITIS* kit may be used with the CARIS™ system (diluting and dispensing device). This kit is for In vitro diagnostic use. * Detection of the serologic markers for primary systemic small blood vessel vasculitides (ANCA) and for Goodpasture syndrome (GBM).

FIDIS™ VASCULITIS* kit is a multiplex flow immunoassay, which allows simultaneous identification and detection of several antibodies. FIDIS™ VASCULITIS* is based on the use of distinct uniform size color-coded microsphere sets and a benchtop flow cytometer interfaced to digital signal processing hardware and software. A red diode laser beam in the flow cytometer recognizes each set of microspheres on the basis of its unique fluorescence intensity (red and infrared) thus identifying which parameter is being tested. At the same time, a green laser beam illuminates the external second molecule fluorescence to quantify the reaction related to the specific antigen. Three different fluorescently "colored" sets of microspheres are coated with antigens associated with various primary systemic small blood vessel vasculitides and glomerular basement membrane disease (MPO, PR3 and GBM). An additional microsphere (Internal Bead standard) set is coated with anti-IgG to ensure that false negative results due to operational error are detected. The four different sets of microspheres are mixed together. The mixture is lyophilized and constitutes the final microspheres reagent. The test is performed using a 96 wells microplate with a filtering membrane at the bottom of the wells. In the first step, the sample is distributed in each well containing the reconstituted microspheres mixture, allowing any anti-MPO, anti-PR3 or anti-GBM antibodies present to bind to the immobilized antigens on the microspheres, as well as free IgG to bind to the anti-IgG microsphere. After incubation, a wash step using a filtration process removes the unbound antibodies. A phycoerythrin anti-human IgG conjugate is then added that binds to the previously bound antibodies. A final wash step stops the reaction and eliminates the unbound conjugate. The reaction is then measured directly by the flow cytometer, which distinguishes each set of microspheres by its fluorescence color while simultaneously measuring the average fluorescence emitted by the conjugate. A calibration system allows the determination of the titer (AU/mL) of each sample by interpolation for each antigenic specificity.

The FIDIS™ VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticle immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of anti-neutrophil cytoplasmic antibodies (ANCA) directed against Myeloperoxidase (MPO), Serine Proteinase 3 (PR3) and antibodies directed against glomerular basement membrane (GBM) in human serum samples. The results of the FIDIS™ VASCULITIS* test are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of various primary systemic small blood vessel vasculitides and glomerular basement membrane disease. Clinical utility: The detection of ANCA is associated with primary systemic small blood vessel vasculitides: Wegener's granulomatosis, Churg Strauss syndromes, microscopic periarteritis and idiopathic crescentic glomerulonephritis; and the detection of anti-GBM antibodies is associated with Goodpasture's syndrome. FIDIS™ VASCULITIS* kit uses serum only, and is to be run on the FIDIS™ Instrument and MLX-BOOSTER Software. FIDIS™ VASCULITIS* kit may be used with the CARIS™ system (diluting and dispensing device). This test is for In vitro diagnostic use. * Detection of the serologic markers for primary systemic small blood vessel vasculitides (ANCA) and for Goodpasture syndrome (GBM).

The FIDIS™ VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticle immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of anti-neutrophil cytoplasmic antibodies (ANCA) directed against Myeloperoxidase (MPO), Serine Proteinase 3 (PR3) and antibodies directed against glomerular basement membrane (GBM) in human serum samples. The kit includes a 96 wells microplate, vials of color-coded microsphere beads coupled with MPO, PR3, and GBM, plus internal standard beads, sample dilution buffer, calibrator, positive control, negative control, anti-human IgG coupled to phycoerythrin, washing buffer, package insert, microplate assay configuration worksheet, and microplate sealing films. The test is run on the FIDIS™ Instrument and MLX-BOOSTER Software and may be used with the CARIS™ system (diluting and dispensing device).

The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescentbased microparticles immunoasay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDa and 52 kDa), SSB, Sm, Sm/RNP, Scl70, Jo1, ribosome and centromere. (*Antibodies to dsDNA, Sm, Sm/RNP, SSA, SSB, Scl-70, Jo-1, ribosome and centromere can be reported using this assay). Clinical utility: The results of the FIDIS™ CONNECTIVE 10* are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of connective diseases (systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis and CREST syndrome). FIDIS™ CONNECTIVE 10* kit uses serum only, and is to be run on the FIDIS™ Instrument and MLX-BOOSTER™ Software. FIDIS™ CONNECTIVE 10* kit may be used with the CARIS™ system (diluting and dispensing device). This test is for in vitro diagnostic use.

The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescentbased microparticles immunoasay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDa and 52 kDa), SSB, Sm, Sm/RNP, Scl70, Jo1, ribosome and centromere. The kit includes a 96 wells microplate, vials of color-coded microsphere beads coupled with antigens and internal standard beads, sample dilution buffer, calibrator, positive control, negative control, anti-human IgG coupled to phycoerythrin, washing buffer, reconstitution buffer, package insert, microplate assay configuration worksheet, and microplate sealing films. The test is run on the FIDIS™ Instrument and MLX-BOOSTER™ Software, and may be used with the CARIS™ system (diluting and dispensing device).

The FIDIS™ THYRO kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is designed for the detection of antibodies directed against thyroperoxydase (TPO) and thyroglobuline (TG). Clinical utility: The test system is used on serum samples as an aid in the diagnostic of auto-immune thyroid pathologies (Graves' disease and Hashimoto thryroiditis), in conjunction with clinical findings and other laboratory tests. The FIDIS™ THYRO kit is to be used on FIDIS™ Analyser, software and washer.

The assay kits consist of: - a vial of color-coded microsphercs coupled with thyroperoxydase (TPO) or thyroglobulin (TG) - a ready to use anti-human IgG coupled to phycocrythrin, - a ready to use calibrator titered for the specificity, - a positive control IgG to be diluted, - a negative control to be diluted, - a 10X concentrated PBS-Tween. Rk: Calibrators, positive and negative controls are diluted human sera. The FIDIS™ System is a fully integrated and automated system for immunodiagnostic testing. FIDIS™ System comprised of FIDIS flow cytometer, XYP platform for automatic sampling into the analyser, the analyzer itself, a SD pump, some FIDIS™ kits and a software MLX-BOOSTER. The FIDIS™ THYRO kit resembles traditional EIA and allows the detection and identification of antibodies against thyroperoxydase (TPO) and thyroglobuline (TG). - 1. Diluted patient sera and microsphere suspension are thoroughly mixed in the 96 well microtiter plate. TPO or TG specific antibodies in the patient sera, if present, bind to the immobilised antigen on the beads. Any unbound material is removed by performing a wash step. - 2. Phycoerythrin-conjugated goat anti-human IgG is added to the plate and a further incubation performed. The conjugated anti-human IgG binds to the TPO or TG specific antibodies immobilised on the microsphere surface to form an antigen/antibody complex. - 3. The bead suspension is then analysed by the FIDIS™ Instrument and reactions are directly calculated in biological units using specific data software (MLX-BOOSTER). The FIDIS™ Instrument is able to distinguish the specific color-coded of the microsphere and it could associated the microsphere type with the individual tested antigen. The FIDIS™ Instrument could quantify the fluorescence of the antibody captured by each microsphere. Measurement of the fluorescent signal from the final reaction complex allows the quantification of the presence or absence of autoantibodies.

The FIDIS™ dsDNA kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is designed for the detection of antibodies directed against double stranded DNA (dsDNA). Clincal unlity: The test system is used on serum samples as an aid in the diagnostic of systemic lupus erythematosus (SLE), in conjunction with clinical findings and other laboratory tests. The FIDIS™ dsDNA kit is to be used on FIDIS™ Analyser, software and washer.

The assay kits consist of - a vial of color-coded microspheres coupled with dsDNA - a ready to use anti-human IgG coupled to phycoerythrin. - a ready to use calibrator littered for the specificity. - a positive control lgG to be diluted, - a negative control to be diluted, - a 10X concentrated PBS-Tween. Rk Calibrators, positive and negative controls are diluted human sera The FIDIS™ System is a fully integrated and automated system for invmunodiagnostic lesting FIDIS™ System comprised of FIDIS flow cylometer. XYP platform for automatic sampling into the analyzer the analyzer itself, a SD pump, some assay products and a software MLX-BOOSTER The IIIDIS™ dsDNA kit resembles traditional EIA and allows the detection and identification of antibodies against dsDNA - i . Diluted patient sera and microsphere suspension are thoroughly mixed in the 96 well microtiter plate. dsDNA specific antibodies in the patient sera, if present, bind to the immobilised untigen on the beads. Any unbound material is removed by performing a wash step. - 2. Phycoerythrin-conjugated goal anti-human IgG is added to the plate and a further antibedies, immentiliand antibodies immobilised on the microsphere surface to form an antigen/antibody complex - 3. The bead suspension is then analysed by the FIDISTM Instrument and reactions are directly calculated in biological units using specific data software (MLX-BOOSTER) The FIDIS™ Instrument is able to distinct the specific code-colored of the microsphere and it could associated the microsphere type with the individual tested antigen. The FIDIS™ Instrument could quantify the finorescente of the antibody captured by each microsphere. Measurent of the finorescence of the antibody captured by allows the overl allows the quantification of the presence or absence of autoantibudies m It's a simple (just two steps) and quick (2 x 30 minutes for the two incubations).

The FIDIS™ CELIAC kits are quantitative homogeneous fluorescent-based microparticles immunoassays using flow cytometry readings. They are designed for the simultaneous detection of human isotype IgA and/or IgG autoantibodies directed against Gliadin and tissue Transglutaminase Enzyme. The presence of tissue Transglutaminase and Gliadin autoantibodies can be used to aid in the diagnosis of Celiac disease. The FIDIS™ CELLAC kit is a semi-quantitative homogencous fluorescent-hased microparticles immunoassay using flow cytometry readings. It is designed for the simultancous detection of human isotype IgA or IgG antibodies directed against Gliadin and tissue Transglutaminase Enzyme. Clinical utility: The presence of these antibodies can be used in conjunction with clinical findings to aid in diagnosis of Celiac disease. The FIDIS™ CELIAC kit is to be used in serum only The FIDISTM CELIAC Kits are to be used on FIDISTM Analyzer, software and washer.

The assay kits consist of: - a mixture of color-coded microspheres respectively sensitized by Gliadin (Glia) or tissue transglutaminase (tTG), - a ready to use phycoerythrin conjugated anti-human IgA or phycoerythrin conjugated anti-human IgG. - a ready to use calibrator IgA or calibrator IgG, - a positive control IgA or positive control IgG to be diluted, - a negative control to be diluted. - a 10X concentrated PBS-Tween. Rk: Calibrators, positive and negative controls are diluted human sera. The FIDIS™ System is a fully integrated and automated system for immunodiagnostic testing. FIDIS™ System comprised of FIDIS flow cytometer, XYP platform for automatic sampling into the analyser, the analyzer itself, a SD pump, some assay products and a software MLX-BOOSTER. The FIDIS™ CELIAC kits resemble traditional EIA, but allow simultaneous detection and identification of several antibodies in a single well. The serum sample is combined with a mix of microspheres individually coated with gliadin or tTG and form an antigen / antibody complex. After washing, this complex is incubated with phycoerythrin labeled anti-human IgG or IgA. If autoantibodies are present in the sample, the final sandwich complex antigen / human antibody / anti-human antibody will form. Reactions are directly analysed by the cvtometer and calculated in biological units using specific data software (MLX-BOOSTER). The FIDIS™ Instrument is able to distinct the specific color-coded of each microsphere types and it could associated the microsphere type with the individual tested antigen. The FIDIS™ Instrument could quantify the fluorescence of the antibody captured by each microsphere. Measurement of the fluorescent signal from the final reaction complex allows the quantification of the presence or absence of autoantibodies. It's a simple (just two steps), quick (2 x 30 minutes for the two incubations) and multiple parameter test.

The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescent based microparticles immunoassay using flow cytometry readings. It is designed for the simultaneous detection of autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDA and 52 kDA), SSB, Sm. Sm/RNP, Scl-70, Jo-1 ribosome and centromere in human serum. (* Antibodies to dsDNA, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1, ribosome and centromere can be reported using this assay). The test system is used to screen serum samples and detect the presence of antinuclear antibodies associated with connective diseases systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis, and CREST syndrome, in conjunction with clinical findings and other laboratory tests.

The assay kits consist of: - a mixture of color-coded microspheres sensitized respectively by dsDNA, SSA 60kDa, SSA 52kDa, SSB, Sm, Sm/RNP, Scl70, Jo-1, Ribosomes and Centromeres. - a ready to use anti-human IgG coupled to phycoerythrin, - a ready to use calibrator titered for each specificity, - a positive control IgG to be diluted. - a negative control to be diluted, - a 10X concentrated PBS-Tween. Rk: Calibrators, positive and negative controls are diluted human sera. The FIDIS™ System is a fully integrated and automated system for immunodiagnostic testing. FIDIS™ System comprised of FIDIS flow cytometer, XYP platform for automatic sampling into the analyser, the analyzer itself, a SD pump, some assay products and a MLX-BOOSTER software. The FIDIS™ CONNECTIVE 10 kit resembles traditional EIA, but allows simultaneous detection and identification of several antibodies in a single well. - 1. Diluted patient sera and multiplexed bead suspension are thoroughly mixed in the 96 well microtiter plate. Antigen specific antibodies in the patient sera, if present, bind to the immobilised antigen on one or more of the bead sets. Any unbound material is removed by performing a wash step. - 2. Phycoerythrin-conjugated goat anti-human IgG is added to the plate and a further incubation performed. The conjugated anti-human igG binds to the antigen specific antibodies immobilised on the microsphere surface to form an antigen/antibody complex. - 3. The bead suspension is then analysed by the FIDIS™ Instrument and reactions are directly calculated in biological units using specific data software (MLX-BOOSTER). The FIDIS™ Instrument is able to distinguish the specific color-code of each microsphere types and it could associate the microsphere type with the individual tested antigen. The FIDIS™ Instrument can quantify the fluorescence of the antibody captured by each microsphere. Measurement of the fluorescent signal from the final reaction complex allows the quantification of the presence or absence of autoantibodies.

The FIDIS™ VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. The test system is used to detect in patient serum samples the presence of anti-neutrophil cytoplasm antibodies (ANCA) directed against Myeloperoxidase (MPO) and Serine Proteinase 3 (PR3) ; and anti-glomerular basement membrane (GBM) antibodies. The results of the FIDIS™ VASCULITIS* test are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of various primary systemic small vessel vasculitis. Clinical utility: The presence of anti-MPO and anti-PR3 antibodies associated primary systemic small vessel vasculitis: Wegener's granulomatosis, Churg Strauss syndromes, microscopic periarteritis and idiopatic crescentic glomerulonephritis; and the presence of anti-GBM antibodies is associated with Goodpasture's syndrome. FIDIS™ VASCULITIS* kit is used on the FIDIS Analyser, MLX-BOOSTER Software and Washer. FIDIS™ VASCULITIS* kit could be used with CARIS™ system (diluting and dispensing device). This test is for in vitro diagnostic use. * Detection of the serologic markers for primary systemic small vessel vasculitis (ANCA) and for Goodpasture syndrome (GBM)

The FIDIS™ VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings.

The FIDISTN CONNECTIVE 8* kit is a semi-quantitative homogencous fluorescentbased microparticles immunoassay using flow cytometery readings. It is designed for the simultaneous detection of 8 autoantibody specificities: double stranded DNA (dsDNA), SSA 60 kDa, SSA 52 kDa, SSB, Sm, Sm/RNP, Sc170 and Jo-1 (*antibodies to dsDNA, Sm, Sm/RNP, SS-A, SS-B, Scl-70 and Jo-1 can be reported using this assay). Clinical utility: The test system is used to screen serum samples and detect the presence of anti-nuclear antibodies associated with connective diseases, systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis, polymyositis in conjunction with clinical findings and other laboratory tests.

The FIDISTN CONNECTIVE 8* kit is a semi-quantitative homogencous fluorescentbased microparticles immunoassay using flow cytometery readings.