50301 – DotDiver Anti-Gangliosid screen

Highlights

• Use of highly purified ganglioside antigens (Sulfatide, GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b)
• Detection of both IgG and IgM antibodies
• Ready-to-use (except wash buffer) and barcoded reagents
• Quality-assured handling in routine laboratories
• Short incubation times at room temperature
• Excellent diagnostic sensitivity and specificity for autoimmune neuropathies
• High precision within the measurement range
• CE marked

Intended Use

The DotDiver Anti-Gangliosid Screen is a qualitative line immunoassay for the determination of IgG and IgM antibodies against multiple ganglioside antigens in human serum. The assay targets a panel of gangliosides including Sulfatide, GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, and GQ1b. The DotDiver Anti-Gangliosid Screen is intended as an aid in the diagnosis of autoimmune neuropathies in conjunction with other clinical and laboratory findings. The immunoassay is designed for semi-automated use with th DotDiver instrument. The immunoassay is designed for professional in vitro diagnostic use.

Diagnostic Relevance

Autoimmune neuropathies of the peripheral nervous system present with a range of clinical symptoms, from mild fatigue and non-specific malaise to severe neuromuscular impairment, including respiratory paralysis and cardiac complications. In many cases, these neuropathies are preceded by infections with pathogens such as Campylobacter jejuni, Cytomegalovirus, Epstein-Barr virus, Mycoplasma pneumoniae, or Haemophilus influenzae.

Gangliosides are sialic acid-containing glycolipids that form a major component of neuronal membranes. They play a critical role in nerve conduction and membrane stability. Autoantibodies against gangliosides can cross-react with neuronal gangliosides after infection, triggering inflammatory processes that lead to demyelination and neuronal damage. Detection of IgG and IgM antibodies against specific gangliosides supports the identification and classification of autoimmune neuropathies, facilitating early diagnosis, monitoring, and appropriate therapeutic intervention.

The semi-automated DotDiver system ensures reproducible results with consistent sensitivity and specificity across the panel of ganglioside antigens, making it suitable for routine laboratory testing and research applications.