4272 – AKLIDES^® CytoBead^® ANA

Highlights

• Slides coated with HEp-2 cells and beads coated with dsDNA, Scl-70, SS-A/Ro60, SS-A/Ro52, SS-B, CENP-B, Sm, and Sm/RNP
• Semi-quantitative determination of IgG antibodies against nuclear and cytoplasmic antigens (ANA)
• Ready-to-use reagents (exception: PBS buffer)
• Quantitative determination of IgG antibodies against specific autoantigens
• Short incubation times at room temperature
• Consistent processing for parallel use of multiple IF assays
• High diagnostic sensitivity and specificity
• Automated imaging using the AKLIDES® or akiron® systems
• CE marked

Intended Purpose

The AKLIDES^® CytoBead^® ANA is an immunofluorescence assay (IFA) for the semi-quantitative determination of IgG antibodies against nuclear and cytoplasmic antigens (ANA) and quantitative determination of IgG antibodies against sDNA, Scl-70, SS-A/Ro60, SS-A/Ro52, SS-B, CENP-B, Sm and Sm/RNP in human serum. The AKLIDES^® CytoBead^® ANA 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 akiron^® or AKLIDES^® systems. The immunoassay is designed for professional in vitro diagnostic use only.

Diagnostic Relevance

The appearance of autoantibodies directed against components of the cell nucleus are characteristic features of systemic autoimmune diseases, especially; SLE, Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA) and dermatomyositis. Clinicians routinely detect autoantibodies in patient samples, such as plasma and serum, which play an essential role in diagnosing systemic autoimmune diseases. Determination of these autoantibodies using AKLIDES® CytoBead® ANA indirect immunofluorescence on fixated HEp-2 cells allows further ANA differentiation of relevant antigens via multiplex bead technology in one well.

Publications

• Zaripova et al., (2025) SSc with Interstitial Lung Disease-Identification of Novel Immunogenetic Markers and Ethnic Specificity in Kazakh Patients
• Fitriah et al., (2023) The Discrepancy of ANA and Compartment Bead Patterns Suggestive of a Neuropsychiatry SLE
• Sowa et al., (2017) Next-Generation Autoantibody Testing by Combination of Screening and Confirmation-the CytoBead® Technology
• Sowa et al., (2014) Der CytoBead-Assay – Eine neue Möglichkeit der multiparametrischen AutoAbsanalytik bei systemischen Autoimmunerkrankungen