Trinity Biotech Plc. products

The Captia™ Syphilis Total Antibody EIA kits is intended for use by appropriately trained and qualified personnel for the detection of antibodies to Treponema pallidum in human serum and plasma. The product may be used for the screening of blood donors, the screening of pregnant women, and to aid in the diagnosis of patients where syphilis infection is suspected.

The Captia™ Malaria Total Antibody EIA intended for use by appropriately trained and qualified personnel for the detection of antibodies to P.falciparum, P.vivax, P.ovale and P.malariae in human serum and plasma.

The Captia Malaria Total Antibody EIA is intended for use by appropriately trained and qualified personnel for the detection of antibodies to P.falciparum, P.vivax, P.ovale and P.malariae in human serum and plasma.

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.