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Special Instructions
This assay currently is not available in New York state.
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This assay |
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This assay currently is not available in New York state. |
Expected Turnaround Time
5 - 7 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
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 IgG ELISA is intended for the qualitative determination of human IgG autoantibodies directed against monosialotetrahexosylganglioside (GM1) in human serum.1
Limitations
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Methodology
Enzyme Linked Immunoassay (ELISA) for IgG antibodies to the ganglioside GM1
Reference Interval
0 - 30%
Additional Information
The ganglioside GM1 is expressed in the peripheral nervous system in the nodes of Ranvier, outer myelin, and the end plates of motor neurons.2 IgG antibodies against GM1 (Anti-GMI IgG) are strongly associated with motor axonal variants of Guillain-Barre syndrome.3,4
GBS is a rapid-onset, immune-mediated demyelinating polyneuropathy associated with acute flaccid paralysis.5,7 The initial symptoms of GBS typically involve symmetrical limb weakness and loss of tendon reflexes. Two major symptoms of GBS are defined by electrophysiological and pathological criteria.4,6-8 The classical, demyelinating form of GBS associated with impairment of the motor or sensory nerve fibers is referred to as Acute Inflammatory Demyelinating Polyneuropathy (AIDP). A second subtype of GBS associated with the myelin or the axonal impairment is referred to as Acute Motor Axonal Neuropathy (AMAN).6,9 AMAN is characterized by acute paralysis and loss of reflexes without sensory loss. AMAN is the most common GBS variant, accounting for as many as 5-10% of cases with much higher incidence in Asia.10
Multiple studies have found an association between AMAN and Anti-GM1 IgG seropositivity.8,9,11-18 Certain electrophysiologic features, such as reversible conduction failure, have been associated with the presence of Anti-GM1 IgG.13,18-21 It is thought that antibodies to GM1 bind to at the nodes of Ranvier activating complement and disrupting sodium-channel clusters and axoglial junctions, leading to nerve conduction failure and muscle weakness.8
The recognition that diarrheal illness can precede GBS has led some to hypothesize that an infectious agent may cause the development of Anti-GM1 IgG, possibly due to molecular mimicry resulting from antecedent infection.15 Campylobacter jejuni infection has been associated with the development of AMAN.8,22 Several other antecedent infectious agents have been recognized including the most recently identified, Zika virus.23
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. Arcila-Londono X, Lewis RA. Guillain-Barré syndrome. Semin Neurol. 2012 Jul;32(3):179-186.23117942
4. Emilien D, Hugh W. Diagnostic Utility of Auto Antibodies in Inflammatory Nerve Disorders. J Neuromuscul Dis. 2015 Jun;2(2):107-112.27858733
5. Hughes RA, Cornblath DR. Guillain-Barré syndrome. Lancet. 2005 Nov 5;366(9497):1653-1666.16271648
6. Goodfellow JA, Willison HJ. Guillain-Barré syndrome: A century of progress. Nat Rev Neurol. 2016 Dec;(12):723-731.27857121
7. Wijdicks EF, Klein CJ. Guillain-Barré Syndrome. Mayo Clin Proc. 2017 Mar;92(3):467-479.28259232
8. Kuwabara S, Yuki N. Axonal Guillain-Barré syndrome: Concepts and controversies. Lancet Neurol. 2013 Dec;12(12):1180-1188.24229616
9. Shahrizaila N, Yuki N. Antiganglioside antibodies in Guillain-Barré syndrome and its related conditions. Expert Rev Neurother. 2011 Sep;11(9):1305-1313.21864076
10. Bourque PR, Chardon JW, Massie R. Autoimmune peripheral neuropathies. Clin Chim Acta. 2015 Sep 20;449:37-42.25748038
11. Sekiguchi Y, Uncini A, Yuki N, et al. Antiganglioside antibodies are associated with axonal Guillain-Barré syndrome: a Japanese-Italian collaborative study. J Neurol Neurosurg Psychiatry. 2012 Jan;83(1):23-28.22010183
12. Capasso M, Notturno F, Mazoli C, Uncini A. Involvement of sensory fibres in axonal subtypes of Guillain-Barré syndrome. J Neurol Neurosurg Psychiatry. 2011 Jun;82(6):664-670.21444320
13. Capasso M, Caporale CM, Pomilio F, Gandolfi P, Lugaresi A, Uncini A. Acute motor conduction block neuropathy: another Guillain-Barré syndrome variant. Neurology. 2003 Sep 9;61(5):617-622.12963751
14. Gregson NA, Jones D, Thomas PK, Willison HJ. Acute motor neuropathy with antibodies to GM1 ganglioside. J Neurol. 1991 Dec;238(8):447-451.1779252
15. Yuki N, Hartung HP. Guillain-Barré syndrome. N Engl J Med. 2012 Jun 14;366(24):2294-2304.22694000
16. Ogawara K, Kuwabara S, Mori M, Hattori T, Koga M, Yuki N. Axonal Guillain-Barré syndrome: relation to anti-ganglioside antibodies and Campylobacter jejuni infection in Japan. Ann Neurol. 2000 Oct;48(4):624-631.11026446
17. Ogawara K, Kuwabara S, Koga M, Mori M, Yuki N, Hattori T. Anti-GM1b IgG antibody is associated with acute motor axonal neuropathy and Campylobacter jejuni infection. J Neurol Sci. 2003 Jun 15;210(1-2):41-45.12736086
18. Shahrizaila N, Kokubun N, Sawai S, et al. Antibodies to single glycolipids and glycolipid complexes in Guillain-Barré syndrome subtypes. Neurology. 2014 Jul 8;83(2):118-124.24920848
19. Kuwabara S, Yuki N, Koga M, et al. IgG anti-GM1 antibody is associated with reversible conduction failure and axonal degeneration in Guillain-Barré syndrome. Ann Neurol. 1998 Aug;44(2):202-208.9708542
20. Kokubun N, Nishibayashi M, Uncini A, Odaka M, Hirata K, Yuki N. Conduction block in acute motor axonal neuropathy. Brain. 2010 Oct;133(10):2897-2908.20855419
21. Susuki K, Johkura K, Yuki N, Hasegawa O, Kuroiwa Y. Rapid resolution of nerve conduction blocks after plasmapheresis in Guillain-Barré syndrome associated with anti-GM1b IgG antibody. J Neurol. 2001 Feb;248(2):148-150.11284136
22. van den Berg B, Walgaard C, Drenthen J, Fokke C, Jacobs BC, van Doorn PA. Guillain-Barré syndrome: pathogensis, diagnosis, treatment and prognosis. Nat Rev Neurol. 2014 Aug;10(8):469-482.25023340
23. 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
References
Chalah MA, et al. A comparison of four commercial tests for detecting anti-ganglioside antibodies in patients with well-characterized dysimmune peripheral neuropathies. 2016.
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
Islam Z, Jacobs BC, van Belkum A, et al. Axonal variant of Guillain-Barré syndrome associated with Campylobacter infection in Bangladesh. Neurology. 2010 Feb 16;74(7):581-587.20157160
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
Mani B, et al. The Frequency of anti-Ganglioside Antibodies in Blood Donors Compared to Control Groups and Guillain-Barré Syndrome Patients. Poster presented at DAS, Dresden (GE). 2010.
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
Uncini A, Yuki N. Electrophysiologic and immunopathologic correlates in Guillain-Barré syndrome subtypes. Expert Rev Neurother. 2009 Jun;9(6):869-884.19496690
Uysalol M, Tatli B, Uzel N, Citak A, Aygün E, Kayaoğlu S. A Rare Form of Guillain-Barré Syndrome: A Child Diagnosed with Anti-GD1a and Anti-GD1b Positive Pharyngeal-Cervical-Brachial Variant. Balkan Med J. 2013 Sep;30(3):337-341.25207134
Wurster U, et al. Ganglioside Antibodies in Amyotrophic Lateral Sclerosis. Poster presented at DAS, Dresden (GE). 2009.
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