8065 – CytoBead^® ANA

Highlights

• qualitative and semi-quantitative detection of IgG antibodies against nuclear and cytoplasmic antigens (dsDNA, Scl-70, SS-A/Ro60, SS-A/Ro52, SS-B, CENP-B, Sm, Sm/RNP)
• Supports the diagnosis of systemic autoimmune diseases
• Ready-to-use reagents for manual processing
• Quality assured handling in routine laboratories
• Consistent processing for parallel use of multiple IF assays
• High diagnostic sensitivity and specificity
• Automated imaging using AKLIDES® or akiron®NEO systems
• CE marked

Intended Purpose

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

Diagnostic Relevance

Autoantibodies that target the cell nucleus often appear in systemic autoimmune diseases. These include systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA), and dermatomyositis.

Detecting autoantibodies in patient samples, such as plasma or serum, is well established and plays a key role in diagnosing systemic autoimmune diseases.

Using HEp-2 cells in immunofluorescence assays provides a highly sensitive method to detect antinuclear antibodies (ANA). Clinicians can identify the staining patterns on HEp-2 cells to determine which antigen ANA targets and the related autoimmune disorder.

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
• Fitriah 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