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HEp-2 (Evan's Blue)
Technology : IFA ~ ANA Screen Brand : MarDx® ~ ANA Screen Analyte : Autoimmune ~ Systemic Rheumatoid Diseases Intended UseMarDx Antinuclear Antibody Test System is intended for testing human serum for the presence of human antinuclear antibodies (ANA) as an aid in the diagnosis of chronic autoimmune disorders. High Complexity Test.PrincipleThe HEp-2 substrate utilized in this IFA test system contains a mixture of cells in various mitotic stages. The majority of the cells are in a resting phase (interphase), the ideal phase for routine ANA screening. The remainder are a mixture of the four phases of mitosis: 1. prophase 2. metaphase 3. anaphase 4. telophase. When interpreting the patient sample, both resting and mitotic cells should be evaluated.ANA antibodies are not organ or species specific. The primary test reaction involves circulating antinuclear antibodies present in the patient's serum which attach to their homologous nuclear antigens. The primary reaction occurs during the first incubation period while the patient's serum covers the substrate. The secondary reaction follows a PBS rinsing to remove any unbound human antibody. The reagent used in the secondary reaction is a fluorescein labeled anti-human conjugate which has been affinity purified for use with HE-p2 cell culture substrates and has been adjusted for the optimum use dilution and is free of most nonspecific staining of the HEp-2 cell. After a second PBS rinse to remove any unbound anti-human globulin conjugate, the specific type of nuclear fluorescence observed and its fluorescence intensity is reported visually using a fluorescence microscope at a magnification of 400X. Product Code : 10-1240 Format : MarDx® 12 well Test/Kit : 240 tests FDA : Cleared CE : Cleared Canadian Licensed: : Cleared Additional Information : Insert Version : MDN 04-0022eng rev.8
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