ANA HEp-2 Test System - 20 Slides

Intended Use

ZEUS IFA™ ANA HEp-2 Test System is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of IgG anti-nuclear antibodies in human serum by manual fluorescence microscopy or with ZEUS dIFine®. The presence of anti-nuclear antibodies can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of systemic lupus erythematosus and other systemic rheumatic diseases.   ZEUS dIFine is an automated instrument consisting of a fluorescent microscope and software that acquires, interprets, stores and displays digital images of stained indirect immunofluorescence slides. ZEUS dIFine can only be used with FDA cleared or approved ZEUS in vitro diagnostic assays that are indicated for use on this instrument.   All suggested results obtained with ZEUS dIFine must be confirmed by a trained operator.

Product Description

• HEp-2 cells with natural, unaltered antigens in every well
• This test system contains liquid, ready-to-use components with volumes optimized for automation
• 12 mL bottle of FITC conjugate formulated with Evans Blue counterstain
• 12 mL bottle of mounting media
• 4 x 30 mL bottles of Zorba-NS sample diluent required for use with ZEUS dIFine

Kit Size

20 x 12 wells

Registration / Clearance

FDA Cleared

CE Marked

Health Canada Licensed