Infectious Disease Products

The Trinity Biotech Captia™ Herpes Simplex Virus type 2 (HSV 2) IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the in vitro semi-quantitative determination of IgM antibodies in human serum to Herpes simplex type 2 virus and as an aid in the diagnosis of herpes related diseases. High complexity test.

The Trinity Biotech Captia™ Epstein-Barr Virus Capsid Antigen (EBV VCA) IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative determination of IgG antibodies to Epstein-Barr virus in human serum. The Trinity Biotech anti-EBV VCA IgG assay may be used in conjunction with other Epstein-Barr serologies as an aid in the diagnosis of infectious mononucleosis in the adult population. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Cytomegalovirus (CMV) IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of IgM antibody to cytomegalovirus in human serum. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Measles IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the in vitro determination of Measles IgM antibodies in human serum. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Mumps IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of IgM antibodies in human serum to Mumps for the determination of immunological experience. High complexity test.

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™ NMT Syphilis IgM EIA is intended for the detection of IgM specific antibodies to Treponema pallidum (T. pallidum) in human serum or plasma and is used in the differential diagnosis of syphilis infections.

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

The Bartels FlexTrans™ Transport Medium is intended to stabilize viruses and Chlamydiae, and suppress microbial contamination during transport of clinical specimens from the point of colletion to the testing site. For invitro Diagnostic Use.

The Bartels Legionella Urinary Antigen ELISA Test is intended as an adjunct to culture for the presumptive diagnosis of past or current Legionnaires’ Disease by qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine.

The Trinity Biotech Captia™ Legionella pneumophila IgG/IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of total antibodies (IgG and IgM) to Legionella pneumophila (Legionella) serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Herpes Simplex Virus (HSV) Combined IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the in vitro semi-quantitative determination of IgM antibodies in human serum to Herpes simplex type 1 and type 2 virus and as an aid in the diagnosis of herpes related diseases. High complexity test.

The Trinity Biotech Captia™ Herpes Group IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to determine serologic status in females of child- bearing age, and to evaluate paired sera for the presence of seroconversions of IgG as an aid in the diagnosis of Herpes simplex virus infection.  For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Herpes Simplex Virus type 1 (HSV 1) IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the in vitro semi-quantitative determination of IgM antibodies in human serum to Herpes simplex type 1 virus and as an aid in the diagnosis of herpes related diseases. High complexity test.

The Trinity Biotech Captia™ Herpes Simplex Virus (HSV) 2 Type Specific IgG kit is an Enzyme-linked Immunosorbent Assay (ELISA) intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-2 in human serum. In conjunction with the Trinity Biotech Captia™ Herpes Simplex Virus (HSV) 1 Type Specific IgG kit, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. Due to the implications of positive results, it is recommended they be confirmed in a low prevalence population with Western Blot.

The Trinity Biotech Captia™ Herpes Simplex Virus (HSV) 1 Type Specific IgG kit is an Enzyme-linked Immunosorbent Assay (ELISA) intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 in human serum. In conjunction with the Trinity Biotech Captia™ Herpes Simples Virus (HSV) 2 Type Specific IgG kit, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. Due to the implications of positive results, it is recommended they be confirmed in a low prevalence population with Western Blot.

The MarDx® B. burgdorferi Disease Enzyme Immunoassay (EIA) IgG Test System is a qualitative test intended for use in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum. This EIA system should be used to test serum from patients with a history and symptoms of infection with B. burgdorferi. For in vitro diagnostic use. High complexity test.

The MarDx® B. burgdorferi Disease Enzyme Immunoassay (EIA) IgM Test System is a qualitative test intended for use in the presumptive detection of human IgM antibodies to Borrelia burgdorferi in human serum. This EIA system should be used to test serum from patients with a history and symptoms of infection with B. Burgdorferi. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ H. pylori IgA Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection and qualitative determination of IgA antibodies to Helicobacter pylori (H. pylori) in human serum. For in vitro diagnostic use. High complexity test.

The MarDx® B. burgdorferi Enzyme Immunoassay (EIA) IgG & IgM Test System is a qualitative test intended for use in the presumptive detection of human IgG & IgM antibodies to Borrelia burgdorferi in human serum. This EIA system should be used to test serum from patients with a history and symptoms of infection with B. burgdorferi. For in vitro diagnostic use. High complexity test.

The MarDx® B. burgdorferi Enzyme Immunoassay (EIA) IgG & IgM Test System is a qualitative test intended for use in the presumptive detection of human IgG & IgM antibodies to Borrelia burgdorferi in human serum. This EIA system should be used to test serum from patients with a history and symptoms of infection with B. burgdorferi. For in vitro diagnostic use. High complexity test.

The MarDx® B. burgdorferi Disease Enzyme Immunoassay (EIA) IgM Test System is a qualitative test intended for use in the presumptive detection of human IgM antibodies to Borrelia burgdorferi in human serum. This EIA system should be used to test serum from patients with a history and symptoms of infection with B. burgdorferi. 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. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Measles IgG Enzyme Linked Immunosorbent Assay (ELISA) is intended for the detection and quantitative determination of IgG antibody to Measles (Rubeola) virus in human sera. Individual serum specimens may be used for the determination of immune status. Paired sera, acute and convalescent, may be used to demonstrate seroconversion or a significant rise in antibody as an aid in the diagnosis of recent or current infection. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Measles IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of Measles IgM antibodies in human serum of patients suspected od measles (rubeola) infection. This assay is intended for use as an aid in the diagnosis of a current or recent measles (rubeola) infection in conjunction with other clinical information and laboratory findings. High complexity test.

The Trinity Biotech Captia™ H. pylori IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of IgG antibodies to Helicobacter pylori in human serum. This assay is intended for use as an aid in the diagnosis of H. pylori infection in persons with gastrointestinal symptoms. For in vitro diagnostic use only. High complexity test.

The Trinity Biotech Captia™ Mumps IgG Enzyme linked Immunosorbent Assay (ELISA) is intended for the detection and quantitative determination of IgG antibody to Mumps virus in human sera. Individual serum specimens may be used for the detection of immune status. Paired sera, acute and convalescent, may be used to demonstrate seroconversion or a significant rise in antibody, as an aid in the diagnosis of a recent or current infection. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Mumps IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of IgM antibody in human serum to Mumps for the determination of immunological experience The performance characteristics of this kit have not been established. High complexity test.

The Trinity Biotech Captia™ Epstein-Barr Virus Viral Capsid Antigen (VCA) IgM kit is an Enzyme-Linked Immunosorbent Assays (ELISA) intended for the qualitative determination of IgM antibodies in human serum to VCA antigen. The Trinity Biotech anti-VCA IgM assay may be used in conjunction with other Epstein-Barr serologies as an aid in the diagnosis of infectious mononucleosis in adult populations. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Mycoplasma IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the semi-quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The Trinity Biotech Mycoplasma IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions and a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Epstein-Barr Virus Early Antigen Diffuse (EA-D) IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative determination of IgG antibodies in human serum to EA-D antigen. The Trinity Biotech anti-EA-D IgG assay may be used in conjunction with other Epstein-Barr serologies as an aid in the diagnosis of infectious mononucleosis. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Rubella IgG Enzyme- Linked Immunosorbent Assay (ELISA) is intended for the in vitro diagnostic detection and determination of IgG antibody to rubella virus in human sera. Individual serum specimens may be used for the determination of Immune Status. Paired sera, acute and convalescent, may be used to demonstrate seroconversion of a significant rise in antibody level, as an aid in the diagnosis of a recent or current infection. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Rubella IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the in vitro qualitative determination of IgM antibodies in human serum and as an aid in the diagnosis of current or recent infection with Rubella virus. High complexity test.

Captia™ Syphilis (T. pallidum )-G is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis).

Captia™ Syphilis (T. pallidum )-G is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis. For in vitro Diagnostic Use Only. For professional Use Only.

The Trep-Sure™ Total Antibody EIA is a qualitative enzyme immunoassay for the in vitro diagnostic detection of Treponema pallidum (syphilis) antibodies in human serum or EDTA and citrated plasma. This product can be used as an initial screening test or as a confirmatory diagnostic test.

The Trinity Biotech Captia™ Toxoplasma gondii (Toxo) IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the presumptive qualitative detection of IgM antibody to Toxoplasma gondii in human serum for the presumptive diagnosis of acute, recent, or reactive Toxoplasma gondii infection. Testing of patient sera must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. High complexity test.

The Trinity Biotech Captia™ Toxoplasma gondii (Toxo) IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection and quantitative determination of IgG antibody to Toxoplasma gondii in human sera. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Varicella-Zoster Virus (VZV) IgG Enzyme-linked Immunosorbent Assay (ELISA) is intended for the detection and quantitative determination of IgG antibody to VZV in human sera. Individual serum specimens may be used for the determination of immune status. Paired sera, acute and convalescent, may be used to demonstrate seroconversion or a significant rise in antibody level, as an aid in the diagnosis of primary infection or reactivaion with VZV. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Varicella-Zoster Virus (VZV) IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection of IgM antibody to Varicella-Zoster virus in human serum as an aid in the diagnosis of primary infection or reactivation. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Epstein-Barr Vial Capsid Antigen (EBV VCA (P-18)) IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to VCA antigen. The Trinity Biotech anti-EBV VCA (P-18) IgG assay may be used in conjunction with other Epstein-Barr serologies as an aid in the diagnosis of infectious mononucleosis in the adult population. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Enzyme- Linked Immunosorbent Assay (ELISA) is intended for the qualitative and semi-quantitative determination of IgG antibody in human serum to EBNA-1 recombinant antigen. The Trinity Biotech EBNA-1 IgG assay may be used in conjunction with other Epstein-Barr serologies as an aid in the diagnosis of infectious mononucleosis. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Cytomegalovirus (CMV) IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of IgM antibody to cytomegalovirus in human serum. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Cytomegalovirus (CMV) IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection and semiquantitative determination of IgG antibody to cytomegalovirus in human sera to indicate previous infection with cytomegalovirus. Paired sera, acute and convalescent, may be used to demonstrate seroconversion or a significant rise in antibody level, as an aid in the diagnosis of a recent or current infection, or reactivation. For in vitro diagnostic use. High complexity test.

The Trinity Biotech Captia™ Chlamydia IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of IgG antibodies in human serum to Chlamydia for the determination of immunological experience. For in vitro diagnostic use. High Complexity test.