Trinity Biotech provides one of the most comprehensive solutions for autoimmune diagnostics. Our product offering includes a wide range of IFAs, EIAs, Line Immunoassays and Western Blots for an extensive variety of autoimmune disorders.
This device is intended for an indirect immunofluorescence antibody test for the detection and quantitation of antibodies to native (double stranded) deoxyribonucleic acid (nDNA) in human serum
IFA
48
Systemic Lupus Erthematosus (SLE)
FDA: Cleared
CE:Marked
Canada: Cleared
IFU Documents
SDS Documents
This device is intended for the screening and detection by indirect immunofluorescence (IF) of primarily anti-myelin associated glycoproteins (anti-MAG) and other glycolipid autoantibodies in human serum.
Provides 48 determinations
Autoimmune Neuropathies
FDA: Not Cleared
CE: Marked
Canada: Not Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Not Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Not Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Not Cleared, CE Marked Canada Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Not Cleared
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
0.5 ml
IFA
0.5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
5 x 0.5 ml
FDA Cleared, CE Marked Canada Not Cleared
IFA
5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
5 ml
FDA Cleared, CE Marked Canada Cleared
IFA
5 ml
FDA Cleared, CE Marked Canada Cleared
For the detection and quantitative determination of anti-nuclear (ANA), anti-mitochondrial (AMA), and anti-smoth muscle (ASMA) antibodies in human serum
IFA
160
Autoimmune Hepatitis, Pernicious Anemia, Primary Biliary Cirrhosis, Rheumatoid Arthritis, Scleroderma, Sjögren’s Syndrome, Systemic Lupus Erythematosus (SLE)
IFU Documents
SDS Documents
An indirect immunofluorescence antibody test for the detection and quantitation of antibodies to native (double stranded) deoxyribonucleic acid (nDNA) in human serum
IFA
48
Systemic Lupus Erthematosus
FDA
Canada
IFU Documents
SDS Documents
An indirect immunofluorescence antibody test for the detection and quantitation of anti-skin (anticellular and anti-basement membrame) antibodies in human serum.
IFA
48
IFU Documents
SDS Documents
Indirect immunofluorescence (IF) antibody test for the detection and quantitation of antinuclear antibodies (ANA) in human serum.
IFA
120
Systemic Lupus Erthematosus
FDA and Canada Cleared
CE Marked
For the detection and quantitative determination of anti-nuclear (ANA), anti-mitochondrial (AMA), and anti-smoth muscle (ASMA) antibodies in human serum.
IFA
160
Autoimmune Hepatitis, Pernicious Anemia, Primary Biliary Cirrhosis, Rheumatoid Arthritis, Scleroderma, Sjögren’s Syndrome, Systemic Lupus Erythematosus (SLE)
FDA Cleared
Not Canada Cleared
CE Marked
An indirect immunofluorescence antibody test for the detection and semi-quantitation of anti-reticulin antibodies (ARA) in human serum.
IFA
48
Celiac Disease
FDA, Canada Cleared
CE Marked
An indirect immunofluorescence antibody test for the qualitative and semi-quantitative detection of endomysial antibodies (EMA) in human serum as an aid in the diagnosis of celiac disease and dermatitis herpetiformis.
IFA
48
Celiac Disease
FDA, Canada Cleared
CE Marked
An indirect immunofluorescence antibody test for the qualitative and semi-quantitative detection of endomysial antibodies (EMA) in human serum as an aid in the diagnosis of celiac disease and dermatitis herpetiformis.
IFA
48
Celiac Disease
FDA, Canada Cleared
CE Marked
An indirect immunofluorescence antibody test for the qualitative and semi-quantitative detection of endomysial antibodies (EMA) in human serum as an aid in the diagnosis of celiac disease and dermatitis herpetiformis.
Special Order
IFA
96
Celiac Disease
FDA, Not Canada Cleared
CE Marked
An indirect immunofluorescence antibody test for the qualitative and semi-quantitative detection of endomysial antibodies (EMA) in human serum as an aid in the diagnosis of celiac disease and dermatitis herpetiformis.
Special Order
IFA
48
Celiac Disease
FDA, Canada Cleared
CE Marked
Enzyme linked immunoassays (ELISA) for the qualitative and semi-quantitative detection of anti-human Tissue Transglutaminase IgG antibodies in human serum to aid in the diagnosis of gluten sensitive enteropathy / celiac disease (CD) in conjunction with other laboratory and clinical findings.
EIA
96
Celiac Disease
FDA, Canada Cleared
CE Marked
IFU Documents
SDS Documents
Enzyme linked immunoassays (ELISA) for the qualitative and semi-quantitative detection of anti-human Tissue Transglutaminase IgA antibodies in human serum to aid in the diagnosis of gluten sensitive enteropathy / celiac disease (CD) in conjunction with other laboratory and clinical findings.
EIA
96
Celiac Disease
FDA, Canada Cleared
CE Marked
IFU Documents
SDS Documents
An indirect immunofluorescence (IFA) antibody test for the detection and semiquantitation of anti-glomerular basement membrane (GBM) antibodies in human serum.
RUO
IFA
96
Glomerulonephritis, Goodpasture Syndrome
Canada Cleared
Not FDA Cleared
CE Marked
The Trinity Biotech Captia™ Mitochondria Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection and semi-quantitation of antibodies to mitochondria in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of primary biliary cirrhosis. For in vitro diagnostic use. High complexity test.
ELISA
96 Tests
Autoimmune, Hepatolgy, Primary Biliary Cirrhosis
FDA Cleared
Canada Not Cleared
CE Marked
IFU Documents
SDS Version
An enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of antibodies to myeloperoxidase (MPO) in human serum to aid in the diagnosis of anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitides including glomerulonephritis and polyarteritis nodosa in conjunction with other laboratory and clinical findings
EIA
96
Churg-Strauss Syndrome, Crohn’s Disease, Inflammatory Bowel Disease, Primary Sclerosing Cholangitis, Ulcerative Colitis
FDA Cleared, Not Canada Cleared
CE Marked
IFU Documents
SDS Documents
An enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of antibodies to proteinase 3 (PR3) in human serum to aid in the diagnosis of anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitides, including Wegener’s granulomatosis, in conjunction with other laboratory and clinical findings.
EIA
96
Crohn’s Disease, Inflammatory Bowel Disease, Primary Sclerosing Cholangitis, Ulcerative Colitis, Wegener’s granulomatosis
FDA Cleared, Not Canada Cleared
CE Marked
An indirect immunofluorescence antibody test for the detection and semi-quantitation of anti-neutrophil cytoplasmic antibodies (ANCA) in human serum. ANCA are found in the serum of patients with necrotizing vasculitides and hence, serve as an aid to the clinical and other laboratory findings in the diagnosis of these disorders.
IFA
48
Crohn’s Disease, Inflammatory Bowel Disease, Primary Sclerosing Cholangitis, Ulcerative Colitis, Wegener’s granulomatosis
FDA and Canada Cleared
CE Marked
An indirect immunofluorescence antibody test for the detection and semi-quantitation of anti-neutrophil cytoplasmic antibodies (ANCA) in human serum. ANCA are found in the serum of patients with necrotizing vasculitides and hence, serve as an aid to the clinical and other laboratory findings in the diagnosis of these disorders.
IFA
48
Crohn’s Disease, Inflammatory Bowel Disease, Primary Sclerosing Cholangitis, Ulcerative Colitis, Wegener’s granulomatosis
FDA and Canada Cleared
CE Marked
An indirect immunofluorescence antibody test for the detection and semi-quantitation of anti-neutrophil cytoplasmic antibodies (ANCA) in human serum. ANCA are found in the sera of patients with necrotizing vasculitides and hence, serve as an aid to the clinical and other laboratory findings in the diagnosis of these disorders.
IFA
240
Necrotizing Vasculitides
FDA, Not Canada Cleared
CE Marked
An indirect immunofluorescence antibody test for the detection and semi-quantitation of anti-neutrophil cytoplasmic antibodies (ANCA) in human serum. ANCA are found in the sera of patients with necrotizing vasculitides and hence, serve as an aid to the clinical and other laboratory findings in the diagnosis of these disorders.
IFA
96
Crohn’s Disease, Inflammatory Bowel Disease, Primary Sclerosing Cholangitis, Ulcerative Colitis, Wegener’s granulomatosis
FDA and Canada Cleared
CE Marked
The Trinity Biotech Captia™ Proteinase-3 (PR-3) Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection and semi-quantitative determination of antibodies to PR-3 in human sera. The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid in the diagnosis of Wegener’s granulomatosis. For in vitro diagnostic use. High complexity test.
ELISA
96 Tests
Autoimmune, Vasculitis, Wegener’s granulomatosis
FDA Cleared
Canada Not Cleared
CE Marked
IFU Documents
SDS Documents
The Trinity Biotech Captia™ Myeloperoxidase (MPO) IgG,A,M Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection and semi-quantitation antibodies to myeloperoxidase in human sera. This assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of microscopic polyangiitis. For in vitro diagnostic use. High complexity test.
ELISA
96 Tests
Autoimmune, Vasculitis, Microscropic Polyangiitis
FDA Cleared
Canada Not Cleared
CE Marked
IFU Documents
SDS Documents
8×6 well primate thyroid slides with ATA control, IgG conjugate
Special order
EIA
48
Graves Disease, Hashimoto’s Disease
Canada Cleared
Not FDA Cleared
CE Marked
Captia™ Thyroglobulin EIA is intended for the detection and semi-quantitation of antibodies to thyroglobulin in human sera. For in vitro diagnostic use. High complexity test.
ELISA
96 Tests
Autoimmune, Thyroid Disease
FDA: Cleared
Canada: Not Cleared
CE: Marked
IFU Documents
SDS Documents
An indirect immunofluorescence (IFA) antibody test for the detection and semiquantitation of anti-neuronal (paraneoplastic) autoantibodies; anti-Yo, anti-Hu and anti-Ri in human serum.
RUO
IFA
48
Paraneoplastic Syndromes
Canada Cleared, Not FDA Cleared
CE Marked
IFU Documents
SDS Documents
An indirect immunofluorescence test for the detection and semi-quantitation of islet cell antibodies in human serum to aid in the diagnosis of insulin dependent diabetes mellitus (IDDM).
RUO
IFA
40
Diabetes Type 1
Not FDA or Canada Cleared
CE Marked
Line Immunoassay for detecting antibodies associated with Autoimmune Hearing Loss
RUO
LIA
20
Sensorineural Hearing Loss
FDA and Canada Cleared
CE Marked
IFU Documents
SDS Documents
Indirect immunofluorescence antibody tests for the detection and quantitation of anti-nuclear antibodies (ANA), anti-mitochondrial antibodies (AMA), anti-smooth muscle antibodies (ASMA), and anti-gastric parietal cell antibodies (AGPA) in human serum.
IFA
96
Autoimmune Hepatitis, Dermato /Polymyositis, Pernicious Anemia, Primary Biliary Cirrhosis, Rheumatoid Arthritis, Scleroderma, Systemic Lupus Erythematosus (SLE)
FDA Cleared,
CE Marked,
Canada Not Cleared
IFU Documents
SDS Documents
Indirect immunofluorescence (IF) antibody test for the detection and quantitation of antinuclear antibodies (ANA) in human serum.
IFA
240
Systemic Lupus Erthematosus
FDA and Canada Cleared
CE Marked
For the detection and quantitative determination of antinuclear (ANA), antimitochondrial (AMA), and antismooth muscle (ASMA) antibodies in human serum by the indirect fluorescent antibody technique.
IFA
48
Autoimmune Hepatitis, Pernicious Anemia, Primary Biliary Cirrhosis, Rheumatoid Arthritis, Scleroderma, Sjögren’s Syndrome, Systemic Lupus Erythematosus (SLE)
FDA Cleared
Not Canada Cleared
CE Marked
IFU Documents
SDS Documents
Indirect immunofluorescence antibody tests for the detection and quantitation of anti-nuclear antibodies (ANA), anti-mitochondrial antibodies (AMA), anti-smooth muscle antibodies (ASMA), and anti-gastric parietal cell antibodies (AGPA) in human serum.
IFA
48
Autoimmune Hepatitis, Pernicious Anemia, Primary Biliary Cirrhosis, Rheumatoid Arthritis, Scleroderma, Sjögren’s Syndrome, Systemic Lupus Erythematosus (SLE)
FDA Cleared
Not Canada Cleared
CE Marked
An indirect immunofluorescence antibody test for the detection and quantitation of antibodies to native (double stranded) deoxyribonucleic acid (nDNA) in human serum
IFA
48
Systemic Lupus Erthematosus
FDA, Canada Cleared
CE Marked
Indirect immunofluorescence (IF) antibody tests for the detection and quantitation of antinuclear antibodies (ANA).
IFA
240
Dermato/ Polymyositis, Rheumatoid Arthritis, Scleroderma, Systemic Lupus Erythematosus (SLE)
FDA Cleared
Canada Not Cleared
CE Marked
IFU Documents
SDS Documents
Indirect immunofluorescence (IF) antibody tests for the detection and quantitation of antinuclear antibodies (ANA).
IFA
200
Dermato/ Polymyositis, Rheumatoid Arthritis, Scleroderma, Systemic Lupus Erythematosus (SLE)
FDA, CE Cleared Canada Not Cleared
Indirect immunofluorescence (IF) antibody test for the detection and quantitation of antinuclear antibodies (ANA) in human serum.
Special Order
IFA
96
Systemic Lupus Erthematosus
FDA
Canada Cleared
CE Marked
IFU Documents
Available upon request
SDS Documents
ImmuLisa Enhanced™ RF IgM Antibody ELISA: 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 rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
Special Order
EIA
96
Rheumatoid Arthritis
FDA: Cleared
Canada: Not Cleared
CE Marked
ImmuLisa Enhanced™ RF IgG Antibody ELISA: 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 rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
Special Order
EIA
96
Rheumatoid Arthritis
FDA: Cleared
Canada: Not Cleared
CE Marked
An enzyme linked immunosorbant assay (ELISA) for the detection and quantitation of Rheumatoid Factor (RF) IgA isotype in human serum.
Special Order
EIA
96
Rheumatoid Arthritis
FDA: Cleared
Canada: Not Cleared
CE Marked
Enzyme linked immunoassays (ELISA) for the detection and semi-quantitation of SS-A (Ro) or SS-B (La) antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and associated connective tissue disorders.
Special Order
EIA
96
Sjögren’s Syndrome, Systemic Lupus Erythematosus (SLE)
FDA: Cleared
Canada: Not Cleared
CE Marked
An enzyme linked immunoassays (ELISA) for the detection and semi-quantitation of Sm antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and associated connective tissue disorders.
Special Order
EIA
96
Systemic Lupus Erthematosus
FDA: Cleared
Canada: Not Cleared
CE Marked
IFU Documents
SDS Documents
An enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to double stranded DNA (dsDNA) in human serum, as an aid in the diagnosis of systemic lupus erythematosus (SLE)
Special Order
EIA
96
Systemic Lupus Erthematosus
FDA: Cleared
Canada: Not Cleared
CE Marked
The Trinity Biotech Captia™ ENA Profile Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection of antibodies in human serum to individual antigens for Smith, Sm/RNP, SS-A (Ro), SS-B (La), Scl-70 and Jo-1 in a single serum specimen. The results of the assay are to be used as an aid in the diagnosis of Systemic Lupus Erthematosus (SLE), sclerodema, Sjogren’s syndrome (SS), or other systemic rheumatic diseases. For in vitro diagnostic use. High complexity test.
ELISA
12 Tests
Autoimmune Diseases, Connective Tissue, Systemic Rheumatoid
FDA: Cleared
Canada: Not Cleared
CE: Marked
IFU Documents
SDS Documents
The Trinity Biotech Captia™ Histone Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection and semi-quantitation of antibodies to histone in human sera. The assay is to be used to detect antibodies in a single serum specimen. For in vitro diagnostic use. High complexity test.
ELISA
96 Tests
Autoimmune, Systemic Rheumatoid
FDA: Cleared
Canada: Not Cleared
CE Marked
IFU Documents
SDS Documents
