Test ID: GM1B
Ganglioside Antibody Panel, Serum
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Supporting diagnosis of neurological diseases-primarily motor neuron disease and motor neuropathies
Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| IGG_M | IgG Monos. GM1 | No | Yes |
| IGM_M | IgM Monos. GM1 | No | Yes |
| IGG_A | IgG Asialo. GM1 | No | Yes |
| IGM_A | IgM Asialo. GM1 | No | Yes |
| IGG_D | IgG Disialo. GD1b | No | Yes |
| IGM_D | IgM Disialo. GD1b | No | Yes |
Method Name A short description of the method used to perform the test
Quantitative Enzyme-Linked Immunosorbent Assay (ELISA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Asialo GM-1 Antibody
Disialo GD1b
GM1 Antibody Panel
Monosialo GM-1 Antibody
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Collection Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | Mild OK; Gross OK |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Frozen (preferred) | 14 days |
| Refrigerated | 14 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Peripheral neuropathies are a group of disorders that results from lesions on peripheral nerves. Patients with a peripheral neuropathy can have symptoms of weakness, sensory loss, and/or autonomic dysfunction. The causes of acquired peripheral neuropathies are varied, and include vitamin deficiencies, metabolic abnormalities, infections, malignancies (paraneoplastic disorders), and autoimmune diseases. A subset of the autoimmune-mediated peripheral neuropathies is associated with the presence of circulating autoantibodies that bind to specific gangliosides. Gangliosides are glycosphingolipids that contain sialic acid residues. Although present in the plasma membranes of many cell types, gangliosides are particularly abundant in neural tissue.
Guillain-Barre syndrome is one class of autoimmune peripheral neuropathies, and comprises a spectrum of disorders including acute inflammatory demyelinating polyradiculoneuropathy, acute motor axonal neuropathy, and acute motor and sensory axonal neuropathy. This class of autoimmune neuropathies is generally characterized by an acute onset. Although the diagnosis of these disorders is based significantly on clinical evaluation and electrophysiologic studies, assessment of ganglioside antibodies, particularly against GM1, asialo GM1, and GD1b, can provide useful information. It is thought that the Guillain-Barre syndrome disorders are triggered by an infection, which results in production of infection-associated lipooligosaccharide-specific antibodies. These antibodies subsequently bind to endogenous gangliosides, due to molecular mimicry, which leads to immune-mediate damage to the peripheral nerves, ultimately resulting in the clinical symptoms associated with the disorders.(1)
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
99% of Normals Fall at or Below This Titer
| IgG monosialo GM1 | 1:500 |
| IgM monosialo GM1 | 1:1,000 |
| IgG asialo GM1 | 1:4,000 |
| IgM asialo GM1 | 1:4,000 |
| IgG disialo GD1b | 1:1,000 |
| IgM disialo GD1b | 1:1,000 |
Borderline Ranges
| IgG monosialo GM1 | =1:1,000 |
| IgM monosialo GM1 | =1:2,000 |
| IgG asialo GM1 | =1:8,000 |
| IgM asialo GM1 | No borderline range (normal: < or =4,000) |
| IgG disialo GD1b | No borderline range (normal: < or =1,000) |
| IgM disialo GD1b | No borderline range (normal: < or =1,000) |
Abnormal Results
| IgG monosialo GM1 | >1:1,000 |
| IgM monosialo GM1 | >1:2,000 |
| IgG asialo GM1 | >1:8,000 |
| IgM asialo GM1 | >1:4,000 |
| IgG disialo GD1b | >1:1,000 |
| IgM disialo GD1b | >1:1,000 |
Interpretation Provides information to assist in interpretation of the test results
High titers (>1:2,000) have been found only in patients with multifocal motor neuropathy and not with motor neuron disease. About 30% to 50% of patients with these clinical syndromes or the pure motor variant of chronic inflammatory demyelinating polyneuropathy have increased antibody titers. Increased antibody titers, therefore, appear to be a specific but not sensitive marker of those related disorders.
Borderline elevation of titers against ganglioside epitopes may be seen in patients with motor neuron disease or motor neuropathy
For IgG and IgM antibodies directed against monosialo GM1 and disialo GD1b, 99% of 182 age- and sex-stratified normal individuals had titers <1:1,000; 99% of 121 patients with well-defined motor neuron disease had titers <1:2,000; and all patients with titers >1:2,000 had motor neuropathy.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Titer values of 1:250 to 1:2,000 (modest elevations) are found in 5% of patients with motor neuron disease.
Patients with amyotrophic lateral sclerosis may have modest elevations of antiganglioside antibody titer.
High titers have been found only in patients with multifocal motor neuron neuropathy.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Taylor BV, Gross L, Windebank AJ: The sensitivity and specificity of anti-GM1 antibody testing. Neurology 1996;47:951-955
2. Vernino S,Wolfe GI: Antibody testing in peripheral neuropathies. Neurol Clin 2007;25:29-46
3. Kaida K, Ariga T, Yu RK: Antiganglioside antibodies and their pathophysiological effects on Guillain-Barre syndrome and related disorders-a review. Glycobiology 2009;19:676-692
Method Description Describes how the test is performed and provides a method-specific reference
Anti-ganglioside antibodies in serum are detected by enzyme-linked immunosorbent assays (ELISA). Ganglioside antigens (GM1, asialo GM1, and GD1b) adsorbed to wells of ELISA plates are incubated with patient’s serum or controls. The plates are washed and alkaline phosphatase conjugated anti-human IgG or IgM are added in a second incubation. The wash step is repeated and enzyme substrate is added. Absorbance is measured and results are expressed as antibody titer, ie, the greatest dilution at which the absorbance of wells that contain patient’s serum is >2.0 times the mean absorbance of normal sera tested simultaneously.(Taylor BV, Gross L, Windebank AJ: The sensitivity and specificity of anti-GM1 antibody testing. Neurology 1996 October;47:951-955)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday, Wednesday; 5 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
83520 x 6
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| 4414 | IgG Asialo. GM1 | 44738-3 |
| 4416 | IgG Disialo. GD1b | 44742-5 |
| 4412 | IgG Monos. GM1 | 45169-0 |
| 4415 | IgM Asialo. GM1 | 30200-0 |
| 4417 | IgM Disialo. GD1b | 44743-3 |
| 4413 | IgM Monos. GM1 | 44750-8 |
| 4418 | Comment | N/A |
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