50381 – DotDiver Anti-Gangliosid IgG

Highlights

• Determination of IgG autoantibodies against gangliosides (Sulfatide, GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b)
• Supports the diagnosis of autoimmune neuropathies of the peripheral nervous system
• Detection of antibodies associated with post-infectious immune responses (e.g. Campylobacter jejuni, CMV, EBV)
• Ready-to-use reagents (exception: wash buffer)
• High diagnostic sensitivity and specificity
• Clear visual interpretation with positive and cut-off control
• Reproducible results for routine laboratory testing
• Designed for professional in vitro diagnostic use
• CE marked

Intended Use

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

Diagnostic Relevance

Inflammatory neuropathies of the peripheral nervous system present with a broad spectrum of clinical manifestations. Symptoms range from mild fatigue and non-specific malaise to severe neuromuscular impairment, including respiratory paralysis and cardiac complications. Early and accurate serological assessment plays an important role in differential diagnosis and patient management.

Gangliosides, acidic glycolipids composed of ceramide, oligosaccharides, and sialic acid, form essential structural components of neuronal cell membranes and concentrate in the central and peripheral nervous system. Their role in nerve conduction and membrane stability makes them relevant immunological targets in neuropathic disorders.

Patients with autoimmune neuropathies frequently develop IgG autoantibodies against specific gangliosides. These antibodies are often associated with preceding infections caused by Campylobacter jejuni, cytomegalovirus, Epstein-Barr virus, Mycoplasma pneumoniae, or Haemophilus influenzae. Structural similarities between microbial antigens and neuronal gangliosides may trigger molecular mimicry. As a result, cross-reactive antibodies attack gangliosides in the myelin sheath or neuronal membranes, initiate inflammatory responses, and promote demyelination.

The detection of IgG antibodies against defined ganglioside antigens supports the identification and classification of autoimmune neuropathies and contributes to early diagnosis, monitoring, and therapeutic decision-making.