GM1 IgM Autoantibodies

CPT: 83520
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Special Instructions

This assay is not approved for patients of New York State physicians.


Expected Turnaround Time

7 days


Related Documents


Specimen Requirements


Specimen

Serum, frozen


Volume

0.3 mL


Minimum Volume

0.1 mL (Note: This volume does not allow for repeat testing.)


Container

Gel-barrier tube or red-top tube


Collection

Separate serum from cells. Transfer the serum into a LabCorp PP transpak frozen purple tube with screw cap (LabCorp No. 49482). Freeze immediately and maintain frozen at ≤ -20°C until tested. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.


Storage Instructions

Freeze


Stability Requirements

Temperature

Period

Frozen

4 months (stability determined by manufacturer or literature reference)

Freeze/thaw cycles

Stable x2 (stability determined by manufacturer or literature reference)


Patient Preparation

Lipemic samples can be avoided by having the patient fast for 12 hours prior to collection.


Causes for Rejection

Non-serum sample received; non-frozen serum received; grossly lipemic, hemolytic or icteric sample received


Test Details


Use

The BUHLMANN™ Anti-GM1 IgM ELISA is intended for the qualitative determination of human IgM autoantibodies directed against monosialotetrahexosylganglioside (GM1) in human serum.1


Limitations

Anti-GM1 IgM seropositivity is supportive but not sufficient to confirm the diagnosis of MMN and the diagnosis of cannot be excluded by seronegativity for Anti-GM1.15,24,25 Anti-GM1 may also be found in patients with Guillain-Barr syndrome,4,26 acute motor axonal neuropathy, and chronic inflammatory demyelinating polyneuropathy as well as in normal individuals but these are mainly IgG type antibodies.5,15,27 This test, by itself, is not diagnostic and should be used in conjunction with other clinical parameters to confirm disease.

Results of this test are labeled for research purposes only by the assay's manufacturer. The performance characteristics of this assay have not been established by the manufacturer. The result should not be used for treatment or for diagnostic purposes without confirmation of the diagnosis by another medically established diagnostic product or procedure. The performance characteristics were determined by LabCorp.


Methodology

Enzyme Linked Immunoassay (ELISA) for antibodies to the ganglioside GM11


Reference Interval

0 - 30%


Additional Information

GM1 is expressed in the peripheral nervous system in the nodes of Ranvier, outer myelin, and the end plates of motor neurons.2 Measurement of IgM antibodies to GM1 (Anti-GM1) has been employed in the evaluation of with chronic neuropathies that affect the motor nerves. IgM Anti-GM1 seropositivity is significantly associated with multifocal motor neuropathy (MMN).2-6 MMN is a purely motor neuropathy (without sensory loss) that is characterized by progressive, asymmetric muscle weakness and atrophy of limbs.6-12 The hallmark of MMN is the presence of conduction block CB with normal sensory nerve conduction across the region of block.8 The reported prevalence of IgM Anti-GM1 positivity in MMN varies widely (25% to 85%) in the literature, depending on the clinical definition and detection techniques used in various studies.2,13-16 Testing for Anti-GM1 was included among the possible supportive laboratory test for the diagnosis of MMN by the Joint Task Force of the EFNS and the PNS. European Federation of Neurological Societies/Peripheral Nerve Society.17 Higher titers of Anti-GM1 are associated with greater clinical severity in MMN patients but are rare in most other neurological disorders such as ALS and chronic inflammatory demyelinating polyneuropathy.15-16

The underlying cause of MMN is poorly understood but clinical studies suggest that Anti-GM1 autoantibodies directed against myelin antigens, along with autoreactive T cells and macrophages that invade myelin sheath play a causative role.11,18,19 Anti-GM1 antibodies have been shown to bind to the surface of motor neurons, the nodes of Ranvier, and at the neuromuscular junction, where they may exert their effects.2 An autoimmune etiology is further supported the fact that immune modulating therapy improves symptoms for most patients.7,11,18 Approximately 80% of patients with MMN respond to intravenous mmunoglobulins (IVIg). It is important to distinguish MMN from other motor neuron diseases with similar symptoms that are unresponsive to this treatment.8-10 The clinical presentation of MMN can closely mimic several neurological conditions including those with more malignant prognoses such as motor neuron disease.20 There is further value in distinguishing MMN from other immune mediated neuropathies that are responsive to plasma exchanges and steroids, as correct diagnosis is required for choosing the appropriate treatment, with the aim of preventing progressive neuropathy.10,21-23 Testing for anti-GM1 can be useful in cases where MMN is clinically suspected but conduction block is not evident or is in less accessible nerve segments.24


Footnotes

1. Anti-GM1 Autoantibodies ELISA [package insert]. Switzerland: BUHLMANN Labs; Sep. 12, 2016.
2. Steck A, Yuki N, Graus F. Antibody testing in peripheral nerve disorders. Handb Clin Neurol. 2013;115:189-212.23931781
3. Whitesell J. Inflammatory neuropathies. Semin Neurol. 2010 Sep;30(4):356-364.20941668
4. Kuijf ML, van Doorn PA, Tio-Gillen AP, et al. Diagnostic value of anti-GM1 ganglioside serology and validation of the INCAT-ELISA. J Neurol Sci. 2005 Dec 15; 239(1):37-44.16154154
5. McCombe PA, Wilson R, Prentice RL. Results of testing for anti-GM1 antibodies. J Clin Neurosci. 2000 May;7(3):209-212.10833617
6. Leger JM, Guimares-Costa R, Iancu Ferfoglia R. The pathogenesis of multifocal motor neuropathy and an update on current management options. Ther Adv Neurol Disord. 2015 May;8(3):109-122.25941538
7. Bayrak AO, Ulusoy H, Bolat N, Dogan B, Ozbenli T. Multifocal Motor Neuropathy Associated With Infliximab: A Case Report and a Literature Review. Neurologist. 2017 Jul;22(4):144-146.28644258
8. Garg N, Park SB, Vucic S, et al. Differentiating lower motor neuron syndromes. J Neurol Neurosurg Psychiatry. 2017 Jun;88(6):474-483.28003344
9. Querol L, Devaux J, Rojas-Garcia R, Illa I. Autoantibodies in chronic inflammatory neuropathies: diagnostic and therapeutic implications. Nat Rev Neurol. Epub 2017 Jul 14.28708133
10. Rajabally YA. Multifocal motor neuropathy: Review of a treatable immune mediated disorder. Postgrad Med J. 2008 Jun;84(992):287-292.18644918
11. Vlam L, van der Pol WL, Cats EA, et al. Multifocal motor neuropathy: diagnosis, pathogenesis and treatment strategies. Nat Rev Neurol. 2011 Nov 22;8(1):48-58.22105211
12. Bourque PR, Chardon JW, Massie R. Autoimmune peripheral neuropathies. Clin Chim Acta. 2015 Sep 20;449:37-42.25748038
13. Koski CL. Treatment of multifocal motor neuropathy with intravenous immunoglobulin. J Clin Immunol. 2014 Jul;34 Suppl 1:S127-131.24699885
14. Chavada G, Willison HJ. Autoantibodies in immune- mediated neuropathies. Curr Opin Neurol. 2012 Oct;25(5):550-555.22941260
15. Nobile-Orazio E, Gallia F, Terenghi F, Allaria S, Giannotta C, Carpo M. How useful are anti-neural IgM antibodies in the diagnosis of chronic immune-mediated neropathies? J Neurol Sci. 2008 Mar 15;266(1-2):156-163.17915254
16. Cats EA, Jacobs BC, Yuki N, et al. Multifocal motor neuropathy: association of anti-GM1 IgM antibodies with clinical features. Neurology. 2010 Nov 30;75(22):1961-1967.20962291
17. Joint Task Force of the EFNS and the PNS. European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of multifocal motor neuropathy. Report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society--first revision. J Peripher Nerv Syst. 2010 Dec;15(4):295-301.21199100
18. Dalakas MC. Pathogenesis of immune-mediated neuropathies. Biochim Biophys Acta. 2015 Apr;1852(4):658-666.24949885
19. Harschnitz O, Jongbloed BA, Franssen H, Straver DC, van der Pol WL, van den Berg LH. MMN: from immunological cross-talk to conduction block. J Clin Immunol. 2014 Jul;34 Suppl 1:S112-119.24728842
20. Lawson VH, Arnold WD. Multifocal motor neuropathy: A review of pathogenesis, diagnosis, and treatment. Neuropsychiatr Dis Treat. 2014 Apr 5;10:567-576.24741315
21. Latov N. Diagnosis and treatment of chronic acquired demyelinating polyneuropathies. Nat Rev Neurol. 2014 Aug;10(8):435-446.24980070
22. Nowacek DG, Teener JW. Multifocal motor neuropathy. Semin Neurol. 2012 Nov;32(5):500-505.23677657
23. Nobile-Orazio E, Giannotta C. Testing for anti-glycolipid IgM antibodies in chronic immune-mediated demyelinating neuropathies. J Peripher Nerv Syst. 2011 Jun;16 Suppl 1:18-23.21696492
24. Huan MC, Bromberg M. Advances in the laboratory evaluation of peripheral neuropathies. Curr Neurol Neurosci Rep. 2012 Feb;12(1):84-91.22147264
25. Franciotta D, Gastaldi M, Benedetti L, et al. Diagnostics of dysimmune peripheral neuropathies. Neurol Sci. 2017 Oct;38(Suppl 2):243-247.29030769
26. Cats EA, van der Pol WL, Tio-Gillen AP, Diekstra FP, van den Berg LH, Jacobs BC. Clonality of anti-GM1 IgM antibodies in multifocal motor neuropathy and the Guillain- Barré syndrome. J Neurol Neurosurg Psychiatry. 2015 May;86(5):502-504.25157033
27. Caudie C, Quittard Pinon A, Taravel D, et al. Preceding infections and anti-ganglioside antibody profiles assessed by a dot immunoassay in 306 French Guillain-Barré syndrome patients. J Neurol. 2011 Nov;258(11):1958-1964.21516465

References

Cao‐Lormeau VM, Blake A, Mons S, et al. Guillain‐Barré Syndrome outbreak associated with Zika virus infection in French Polynesia: a case‐control study. Lancet. 2016 Apr 9;387(10027):1531‐1539.26948433
Emilien D, Hugh W. Diagnostic Utility of Auto Antibodies in Inflammatory Nerve Disorders. J Neuromuscul Dis. 2015 Jun;2(2):107‐112.27858733
Han TH, Kim DY, Park DW, Moon JH. Transient Isolated Lower Bulbar Palsy With Elevated Serum Anti-GM1 and Anti-GD1b Antibodies During Aripiprazole Treatment. Pediatr Neurol. 2017 Jan;66:96-99.28341090
Kollewe K, Wurster U, Sinzenich T, et al. Anti-ganglioside antibodies in amyotrophic lateral sclerosis revisited. PLoS One. 2015 Apr 14;10(4):e0125339.25875836
Lei T, Siu KL, Kok KH, et al. Anti-ganglioside antibodies were not detected in human subjects infected with or vaccinated against 2009 pandemic influenza A (H1N1) virus. Vaccine. 2012 Mar 30;30(16):2605-2610.22342549
Sharma MB, Chaudhry R, Tabassum I, et al. The presence of Mycoplasma pneumonia infection and GM1 ganglioside antibodies in Guillain-Barré syndrome. J Infect Dev Ctries. 2011 Jul 4;5(6):459-464.21727645

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