50391 – DotDiver Anti-Gangliosid IgM

Highlights

• Use of highly purified ganglioside antigens (Sulfatide, GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b)
• Ready-to-use reagents and barcoded cartridges
• Semi-automated testing with DotDiver instrument
• Qualitative detection of IgM autoantibodies
• Supports diagnosis of autoimmune neuropathies
• Short incubation times at room temperature
• High specificity and sensitivity across the ganglioside panel
• CE marked

Intended Use

The DotDiver Anti-Gangliosid IgM is a qualitative line immunoassay for the determination of IgM antibodies against gangliosides in human serum. The DotDiver Anti-Gangliosid IgM 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 a DotDiver2.0 instrument and professional in vitro diagnostic use.

Diagnostic Relevance

Autoimmune neuropathies of the peripheral nervous system present with a wide spectrum of clinical manifestations, ranging from subtle fatigue and nonspecific malaise to severe neuromuscular deficits, including respiratory paralysis and cardiac dysfunction. Gangliosides, acidic glycolipids containing ceramide, oligosaccharides, and sialic acid, are essential components of neuronal membranes and play a critical role in membrane stability, nerve conduction, and synaptic function.

Clinicians can detect autoantibodies targeting gangliosides in patients with inflammatory neuropathies. Infections with pathogens such as Campylobacter jejuni, cytomegalovirus, Epstein-Barr virus, Mycoplasma pneumoniae, or Haemophilus influenzae often trigger these antibodies. The immune system may generate antibodies against ganglioside-like epitopes on these microorganisms, which can cross-react with human neuronal gangliosides. This molecular mimicry can trigger localized inflammatory responses, demyelination, and subsequent neuronal damage.

The DotDiver Anti-Gangliosid IgM assay detects IgM antibodies against a panel of gangliosides including Sulfatide, GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, and GQ1b. Early detection of these autoantibodies supports the identification and classification of autoimmune neuropathies, enables monitoring of disease progression, and guides targeted therapeutic interventions. The semi-automated DotDiver platform ensures reproducible results, high sensitivity, and specificity, making it suitable for routine laboratory testing as well as research applications.