5035 – DotDiver ANA PCNA

Highlights

• Qualitative detection of IgG autoantibodies against nuclear and cytoplasmic antigens
• Comprehensive antigen panel: Sm, RNP (68 kDa / A / C), Sm/RNP, SSA (Ro), SSB (La), Jo-1, Scl-70, PM-Scl, Ku, CENP-A/B, PCNA, Ribosome P0
• Supports diagnosis of systemic autoimmune diseases (SLE, Sjögren’s syndrome, scleroderma, MCTD, RA, dermatomyositis)
• Semi-automated processing with the DotDiver instrument
• Ready-to-use reagents with breakable test strips (24 × 12 configuration)
• Enzyme-based colorimetric detection using alkaline phosphatase (BCIP/NBT substrate)
• Clear visual interpretation with positive and negative controls
• Designed for professional in vitro diagnostic use
• CE marked

Intended Use

The DotDiver ANA PCNA is a qualitative dot immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (Sm, RNP, Sm/RNP, SS-A/Ro, SSB/La, Jo-1, Scl-70, PM/Scl, Ku, CENP-A/B, PCNA and Ribosome P0) in human serum. It serves as an aid in the diagnosis of systemic autoimmune diseases when interpreted together with clinical findings and additional laboratory parameters.

The assay enables the simultaneous analysis of multiple disease-associated autoantibodies within a single test run, supporting efficient and structured serological evaluation. Semi-automated processing with the DotDiver2.0 instrument ensures standardized incubation, washing, and detection steps, thereby improving reproducibility and workflow reliability in routine laboratories.It is designed for professional in vitro diagnostic use.

Diagnostic Relevance

Autoantibodies directed against nuclear and cytoplasmic components represent hallmark features of systemic autoimmune diseases. These antibodies occur particularly in systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA), and dermatomyositis.

Each antigen included in the panel contributes specific diagnostic information. For example, antibodies to Sm show high specificity for SLE, while SS-A/Ro and SS-B/La antibodies frequently occur in Sjögren’s syndrome and SLE. Scl-70 antibodies associate with diffuse systemic sclerosis, and Jo-1 antibodies indicate idiopathic inflammatory myopathies. PCNA and Ribosome P0 antibodies provide additional differentiation, particularly in lupus-associated disease manifestations.

The detection of these autoantibodies in serum or plasma plays a central role in confirming clinical suspicion, differentiating between overlapping connective tissue diseases, and supporting disease classification. Comprehensive ANA profiling therefore contributes significantly to early diagnosis and appropriate patient management