Trinity Biotech Plc. products

Component of the MarDx® IgM EU Lyme Western Blot Test System, product number 44-2020M. Please refer to the product page for the MarDx® IgM EU Lyme Western Blot Test System for further information.

The Trinity Biotech Captia Borrelia burgdorferi (B. burgdorferi) IgG/IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative presumptive (first-step) detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western-blot (second-step) procedure. Positive supplemental (second- step) results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The diagnosis of Lyme disease must be made based on history, signs (such as erythema migrans), symptoms, and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first- or second step) should not be used to exclude Lyme disease. For in vitro diagnostic use. High Complexity test.

The Trinity Biotech Captia™ Borrelia burgdorferi (B. burgdorferi) IgG/IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative presumptive (first-step) detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western-blot (second-step) procedure. Positive supplemental (second- step) results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The diagnosis of Lyme disease must be made based on history, signs (such as erythema migrans), symptoms, and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first- or second step) should not be used to exclude Lyme disease. For in vitro diagnostic use. High Complexity test.

Component of MarDx® IFA Test systems, product numbers 10-1120, 10-1180; 10-1240; 30-7120; 30-7180; 30-7360; 30-7980. Please refer to the relevant product pages for further information.