ANA HEp-2

Intended Use

ANA HEp-2 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 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.   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. 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 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

 Notice

This product has recently been transitioned to a new format with equivalent performance. The previous format is no longer commercially available.

• If the first two digits of your kit lot number are 24, please refer to the ZEUS package insert under Resources.
• If the first two digits of your kit lot number are 25, please refer to the Sebia IFU under Resources.

If you have any questions during this transition, please don’t hesitate to contact your Sebia sales representative.