4063, 4065 – 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

Physicians diagnose autoimmune diseases based on clinical symptoms and laboratory tests. They confirm the suspicion mainly by detecting antibodies against nuclear or cytoplasmic antigens (ANA), which serve as characteristic markers for systemic autoimmune diseases such as systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (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 indicates the antigen specificity of the detected antibodies and helps identify the corresponding autoimmune disease.

Publications

• Zaripova et al., (2025) SSc with Interstitial Lung Disease-Identification of Novel Immunogenetic Markers and Ethnic Specificity in Kazakh Patients
• Mayr et al., (2025) Pilot Study of AI-Assisted ANA Immunofluorescence Reading-Comparison with Classical Visual Interpretation
• Liedtke et al., (2023) Over-Expr. of LEDGF-p75 in HEp-2 Cells Enhances Autoimmune IgG Response in Patients with PBH-A Novel Diagnostic Approach with Therapeutic Consequence
• Röber et al., (2021) Strong Association of the Myriad Discrete Speckled Nuclear Pattern With Anti-SS-ARo60 Abs
• Akmatov et al., (2017) ANA in the general German population prevalence and lack of association with selected cardiovascular and metabolic disorders
• Loock et al., (2017) Automated evaluation of ANA under real-life conditions
• Egerer et al., (2010) Automated evaluation of autoantibodies on human epithelial-2 cells as an approach to standardize cell-based immunofluorescence tests