4063 – AKLIDES® ANA plus

Highlights

• Slides coated with HEp-2 cells
• Screening test to support for the diagnosis of systemic autoimmune diseases
• Ready-to-use reagents (exception: wash buffer)
• Quality assured handling in routine laboratories
• Short incubation times (30 min / 30 min) at room temperature
• Consistent processing for the parallel use of multiple AKLIDES® IF assays
• Excellent diagnostic sensitivity and specificity
• Imaging by use of AKLIDES® or akiron® systems
• CE marked


Intended Purpose

The AKLIDES® ANA plus is an immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum against nuclear and cytoplasmic antigens (ANA) on HEp-2 cells. The AKLIDES® ANA plus is intended as an aid in the diagnosis of systemic autoimmune diseases in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual processing and automated imaging using the AKLIDES® or akiron® system for imaging. The immunoassay is designed for professional in vitro diagnostic use.


Diagnostic Relevance

The diagnosis of autoimmune diseases is made on the basis of the clinical symptoms and laboratory medical examinations. The clinical suspicion is confirmed in particular by the detection of antibodies against nuclear or cytoplasmic antigens (ANA) as a characteristic feature in systemic autoimmune diseases such as systemic lupus erythematosus (SLE), Sjögren‘s syndrome, progressive systemic sclerosis (PSS), mixed collagenosis (MCTD), rheumatoid arthritis (RA) or dermatomyositis. The use of HEp-2 cells fixed on slides for use in immunofluorescence assays (IFA) has proven to be particularly effective for the determination of antibodies. These immunoassays offer the possibility for a very sensitive detection of antibodies against nuclear or cytoplasmic antigens (ANA). The observed fluorescence pattern also gives an indication of the antigen specificity of the detected antibodies and thus of the autoimmune disease to be diagnosed.

Product Specifications

Title AKLIDES® ANA plus
Product code 4063
Indication Systemic autoimmune diseases
Description Immunofluorescence assay (IFA) for the determination of IgG antibodies against nuclear and cytoplasmic antigens (ANA) in human serum
Format Slides coated with HEp-2 cells
Total incubation time 60 min.
Sample volume 5 µL serum
No. of determinations 480 (40 x 12)

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  Flyer [REF 4063, 4065][eng]   Flyer [REF 4063, 4065][deu]   SDS [REF 4063, 4065][ENG]   SDS [REF 4063, 4065][DEU]

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.