Search Results

INTENDED USE: This is an indirect Fluorescent antibody test for the qualitative and semi-quantitative detection of IgG autoantibodies in human serum by manual fluorescent microscopy or with the Image Navigator® Fluorescence SemiAutomated Microscope. This test system is to be used as an aid in the detection of anti-mitochondrial (AMA), antiparietal cell (APCA), and anti-smooth muscle (ASMA) autoantibodies associated with Type 1 Autoimmune Hepatitis, Primary Biliary Cholangitis, and Pernicious Anemia/Autoimmune Gastritis in conjunction with other laboratory and clinical findings. A trained operator must confirm results generated with the Image Navigator® semi-automated device and software.

Not Found

Instrument: The Immuno Concepts Image Navigator is an automated system consisting of a fluorescent microscope and software that acquires, interprets, stores, and displays digital indirect immunofluorescent slides. The Image Navigator can only be used with cleared or approved Immuno Concepts in vitro diagnostic assays that are indicated for use on the microscope. All suggested results generated by the Image Navigator software must be confirmed by trained laboratory personnel. Assay: This is an indirect fluorescent antibody test for the semi-quantitative detection of IgG antinuclear antibody (ANA) in human serum by manual fluorescent microscopy or with the Image Navigator Fluorescence Semi-Automated Microscope. This test system uses transfected HEp-2000® cells, which allow specific identification of autoantibodies to the SSA/Ro antigen. Autoantibodies to SSA/Ro may show a distinctive staining pattern on the transfected cells. When this pattern is present, it is considered to be confirmatory evidence that anti-SSA/Ro antibodies are present. Absence of this distinctive pattern does not rule out the possible presence of anti-SSA/Ro antibodies. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease in conjunction with other laboratory and clinical findings. A trained operator must confirm results generated with the Image Navigator semi-automated device and software.

The Immuno Concepts Image Navigator is an automated system consisting of a fluorescent microscope and software that acquires, interprets, stores, and displays digital indirect immunofluorescent slides.