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The ImmuGlo HEp-2 Elite IFA is an indirect immunofluorescence antibody test for the qualitative or semi-quantitative detection of anti-nuclear antibodies (ANA) of the IgG isotype in human serum utilizing standard HEp-2 cells and engineered HEp-2 cells as a substrate. The ImmuGlo HEp-2 Elite IFA is intended for use as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.

The ImmuGlo™ HEp-2 Elite IFA is an indirect immunofluorescence antibody test for the qualitative detection of anti-nuclear antibodies (ANA) of the IgG isotype in human serum utilizing standard HEp-2 cells as a substrate. The HEp-2 Elite sides provided with this kit contain a 1:9 mixture of standard HEp-2 cells and engineered HEp-2 cells with the PSP1 gene knocked out. The engineered HEp-2 cells are able to detect all ANA specificities with the exception of the DF570/AC-2 pattern resulting from autoantibodies associated with PSP2. In DF570 positive reactions standard HEp-2 cells provide a positive reaction while engineered HEp-2 cells do not. The HEp-2 Elite substrate thereby provides additionality to aid in discriminating homogeneous, speckled, and dense fine speckled (DFS70/AC-2) patterns during the screening phase.

An enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of anti-RNA POL III IgG antibodies in human serum as an aid in diagnosis of systemic scleroderma) in conjunction with other laboratory and clinical findings.

An enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of anti-RNA POL III IgG antibodies in human serum as an aid in diagnosis (scleroderma) in conjunction with other laboratory and clinical findings. This test is performed as a solid phase immunoassay. Microwells are coated with recombinant RNA POLIII antigen. Controls, calibrators and patient sera are incubated in the antigen coated wells to allow specific antibodies present in the RNA POL III antigen. Bound antibodies are detected by adding an enzyme labeled anti-human IgG conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected by a spectrophotometer at 450 nm. Results are expressed in ELISA units per milliliter (EU/ml) and reported as positive or negative.

An enzyme linked immunosorbent assay (ELISA) for the qualitative detection of anti-mitochondria antibodies (AMA) in human serum to aid in the diagnosis of primary biliary cirrhosis (PBC) in conjunction with other laboratory tests and clinical findings. An enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of anti-mitochondria IgG antibodies in human serum to aid in the diary cirrhosis (PBC) in conjunction with other laboratory tests and clinical findings.

This test is performed as a solid phase immunoassy. Microwells are coated with recombinant Mitochondrial antigen. Controls, calibrators and patient sera are incubated in the antibodies present in the serum to bind to the Mitochondria antigen. Bound antibodies are detected by adding an enzyme labeled anti-human IgG or IgA/JgG/JgM conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected by a color change that is read by a spectrophotometer at 450 nm. Results are expressed in ELISA units per milliliter (EU/ml) and reported as positive or negative. This test is performed as a solid phase immunoassy. Microwells are coated with recombinant mitochondrial antigen. Controls, calibrators and patient sera are incubated in the antigen coated wells to allow specific antibodies present in the serum to bind to the Mitochondria antigen. Bound antibodies are detected by adding an enzyme labeled anti-human IgG or IgA/gG/lgM conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected by a color change that is read by a spectrophotometer at 450 nm. Results are expressed in ELISA units per milliliter (EU/ml) and reported as positive or negative.

Enzyme linked immunosorbent assays (ELISA) for the qualitative detection of IgA anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings Enzyme linked immunosorbent assays (ELISA) for the qualitative detection of IgG anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings

This test is performed as a solid phase immunoassay. Microwells are coated with antigen. Controls, calibrators and patient sera are incubated in the antigen coated wells to allow specific antibodies present in the serum to bind to the gliadin antigen. Bound antibodies are detected by adding an enzyme labeled anti-human IgA or IgG conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected by a color change that is read by a spectrophotometer at 450 mm. Results are expressed in ELISA units per milliliter (EU/ml) and reported as positive or negative.

1. Enzyme-linked immunosorbent assay (ELISA) for the qualitative or semi-quantitative detection of β2-GPI IgA antibodies in human serum to aid in diagnosis of autoimmune thrombotic disorders associated with antiphospholipid syndrome (APS) and APS with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. 2. Enzyme-linked immunosorbent assay (ELISA) for the qualitative or semi-quantitative detection of β2-GPI IgG antibodies in human serum to aid in diagnosis of autoimmune thrombotic disorders associated with antiphospholipid syndrome (APS) and APS with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. 3. Enzyme-linked immunosorbent assay (ELISA) for the qualitative or semi-quantitative detection of β2-GPI IgM antibodies in human serum to aid in diagnosis of autoimmune thrombotic disorders associated with antiphospholipid syndrome (APS) and APS with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. 4. Enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of β2-GPI IgA, IgG and IgM antibodies in human serum to aid in diagnosis of autoimmune thrombotic disorders associated with antiphospholipid syndrome (APS) and APS with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.

The test is performed as a solid phase immunoassay (ELISA) in B2GP1 coated microwells. Controls, Calibrators and patient serum samples are incubated in the antigen coated microwells to allow antibodies present in the serum to bind. Unbound antibody and other serum proteins are removed by washing the microwells are detected by adding an enzyme labeled anti-human lgA, lgG, lgM or lgA/IgG/IgM conjugate to the microwells. These enzyme conjugated antibodies bind specifically to the human immunoglobulin of the apropriate class. Unbound enzyme-labeled conjugate is removed by washing. Specific enzyme substrate (TMB) is then added to the presence of antibodies is detected by a color change produced by the conversion of the TMB substrate. The reaction is stopped and the intensity of color change, which is proportional to the concentration of antibody, is read by a spectrophotometer at 450 nm. Results are expressed in ELISA units per milliliter (EU/ml).

An enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of anti-centromere IgG antibodies in human serum as an aid in diagnosis of limited cutanteous systemic sclerosis / CREST in conjunction with other laboratory and clinical findings.

An enzyme linked immunoassay (EUSA) for the qualitative detection of anti-centromere IgG antibodies in human serum as an aid in diagnosis of limited cutaneous systemic sclerosis / CREST in conjunction with other laboratory and clinical findings. This test is performed as a solid phase immunoassay. Microwells are coated with recombinant purified CENP-A centromere antigens. Controls, calibrators and patient sera are incubated in the antigen coated wells to allow specific antibodies present in the serum to bind to the centromere antibodies are detected by adding an enzyme labeled anti-human lgG conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected by a color change that is read by a spectrophotometer at 450 nm. Results are expressed in ELISA units per milliliter (EU/ml) and reported as positive or negative.

Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA antibodies in human serum to aid in the diagnosis of theumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgG antibodies in human serum to aid in the diagnosis of theumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgM antibodies in human serum to aid in the diagnosis of theumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. Enzyme linked immunoassay (ELISA) for the qualitative detection of Rheumatoid Factor IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of theumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.

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Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of SS-A (Ro) (52 kD and 60 kD) Ig G antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and Sjögren's Syndrome in conjunction with clinical findings and other laboratory tests. Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of SS-B (La) IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and Sjögren's Syndrome in conjunction with clinical findings and other laboratory tests. Enzyme linked immunoassay (ELISA) for the qualitative detection of Sm IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with clinical findings and other laboratory tests. Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of RNP IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and Mixed Connective Tissue Disease (MCTD) in conjunction with clinical findings and other laboratory tests.

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Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of IgA and IgG antibodies to synthetic human tissue transglutaminase (1TG) and deamidated gliadin peptide (DGP) in human serum to aid in the diagnosis of celiae disease (CD) in conjunction with other laboratory tests and clinical findings.

Enzyme linked immunoassay (ELISA)

Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgA antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgG antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgM antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. Enzyme linked immunoassay (ELISA) for the qualitative : detection of Cardiolipin IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of anti-phospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.

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