50301 – DotDiver Anti-Gangliosid screen

Intended Purpose

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


Diagnostic Relevance

Clinical symptoms associated with inflammatory neuropathies of the peripheral nervous system range from mild signs like slight weariness, inexplicable indisposition to complicated cases such as functional deficiency like respiratory paralysis, cardiac arrest and neuromuscular disorders. Gangliosides, acid glycolipids containing a lipid (ceramide), oligosaccharide and sialic acid, are major components of cell membranes and found especially in the central and peripheral nervous system. Autoantibodies to gangliosides are detected in patients suffering from disorders of the peripheral nervous system.

Infection with Campylobacter jejuni, Cytomegalovirus, Epstein-Barr virus, Mycoplasma pneumoniae or Haemophilus influenza are risk factors for inflammatory neuropathies: Antibodies to ganglioside structures of these microorganisms may cross-react with gangliosides of the myelin sheath or neurofibre, leading to activation of inflammation processes with subsequent demyelination.

Product Specifications

Title DotDiver Anti-Gangliosid Screen
Product code 50301
Indication Autoimmune neuropathies
Description Line immunoassay for the qualitative determination of IgG and IgM antibodies against gangliosides in human serum
Format Test strips coated with highly purified sulfatide, GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b and GQ1b
Total incubation time 95 min.
Sample volume 10 µL serum
No. of determinations 24 x 12

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.