Test Catalog

Test Id : GM1B

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Ganglioside Antibody Panel, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Supporting the diagnosis of an autoimmune neuropathy

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

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
IGMTS IgG Monos GM1 Titer, S No No
IMMTS IgM Monos GM1 Titer, S No No
IGATS IgG Asialo GM1 Titer, S No No
IMATS IgM Asialo GM1 Titer, S No No
IGDTS IgG Disialo GD1b Titer, S No No
IMDTS IgM Disialo GD1b Titer, S No No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Screening tests are performed for IgG and IgM antibodies to GM1 and GD1b. If positive, the appropriate titer will be performed at an additional charge.

 

For more information, see Ganglioside Antibody Panel Algorithm.

Method Name
A short description of the method used to perform the test

Enzyme-Linked Immunosorbent Assay (ELISA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Ganglioside Ab Panel, S

Aliases
Lists additional common names for a test, as an aid in searching

Anti-GM1 Antibody

Asialo GM-1 Antibody

Disialo GD1b

GM1 Antibody Panel

Monosialo GM-1 Antibody

GA1

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Screening tests are performed for IgG and IgM antibodies to GM1 and GD1b. If positive, the appropriate titer will be performed at an additional charge.

 

For more information, see Ganglioside Antibody Panel Algorithm.

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send a Neurology Specialty Testing Client Test Request (T732) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 28 days
Frozen 28 days
Ambient 72 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

Supporting the diagnosis of an autoimmune neuropathy

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Screening tests are performed for IgG and IgM antibodies to GM1 and GD1b. If positive, the appropriate titer will be performed at an additional charge.

 

For more information, see Ganglioside Antibody Panel Algorithm.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Neuropathy patients have variable sensory disturbance (loss or exaggerated sensation including with pain), weakness and autonomic involvements (sweat abnormalities, gastrointestinal dysfunction, and lightheadedness on standing). These symptoms are a result of injury to the distal nerves, roots, and ganglia or their gathering points (nerve plexus in the thighs and arms). Patients may have symmetric or asymmetric involvements of the extremities, trunk, and head including extraocular muscles. Subacute onsets and asymmetric involvements favor inflammatory or immune causes over inherited or metabolic forms. Depending on the specific inflammatory or immune mediated causes other parts of the nervous system may also be affected (brain, cerebellum, spinal cord). Nerve conductions and needle electromyography can help to classify the neuropathy as either: 1) primary axonal; 2) primary demyelinating; or 3) mixed axonal and demyelinating.

 

Among the immune-mediated peripheral neuropathies, autoantibodies to gangliosides represent an important class of noncancer-associated autoimmune peripheral neuropathies. Gangliosides are glycosphingolipids that contain sialic acid and are present in many cell types most abundantly within neural tissues along their linings (myelin). Depending on the specific ganglioside autoantibody found and the antibody titer, in the appropriate clinical context, these findings may be supportive of a specific clinical diagnosis and may also be prognostic for treatment response.(1,2)

 

Specifically, in multifocal motor neuropathy (MMN) and multifocal acquired demyelinating sensory and motor (MADSAM) neuropathy, also known as Lewis-Sumner syndrome or multifocal chronic immune demyelinating polyradiculoneuropathy (CIDP), the presence ganglioside autoantibodies, particularly high-titer GM1-IgM autoantibodies, maybe supportive of the diagnosis in the correct clinical context. Furthermore, ganglioside seropositivity has been associated with favorable response to immunotherapy amongst patients suspected to have MMN during the initial clinical evaluation.(1)

 

Additionally, the presence of ganglioside antibodies may support a diagnosis of Guillain-Barre syndrome (GBS) in the appropriate clinical context.(3) GBS 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 dependent on clinical evaluation and electrophysiologic studies, assessment of ganglioside antibodies can further support the diagnosis.

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.

Profile Information:

IGG_M: Negative

IGM_M: Negative

IGG_A: Negative

IGM_A: Negative

IGG_D: Negative

IGM_D: Negative

 

Reflex Information:

IGMTS: <1:2000

IMMTS: <1:4000

IGATS: <1:16000

IMATS: <1:8000

IGDTS: <1:2000

IMDTS: <1:2000

Interpretation
Provides information to assist in interpretation of the test results

High titers (>1:8,000) favor the diagnosis of multifocal motor neuropathy (MMN) and multifocal acquired demyelinating sensory and motor (MADSAM) over motor neuron disease. About 30% to 50% of patients with these clinical syndromes or the pure motor variant of chronic inflammatory demyelinating polyneuropathy have ganglioside autoantibodies. High-antibody titers appear to be a specific, but not sensitive, marker of those related disorders.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Positive titer values less than 1:16,000 may be found in motor neuron disease, monoclonal gammopathy of uncertain significance (MGUS), and healthy individuals. High titers are very specific of an autoimmune neuropathy.

 

This test is not diagnostic and should be interpreted in the appropriate clinical context.

 

This test does not include testing for GD1a or GQ1b autoantibodies.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Martinez JM, Snyder MR, Ettore M, et al: Composite ganglioside autoantibodies and immune treatment response in MMN and MADSAM. Muscle Nerve 2018;57:1000-1005 doi: 10.1002/mus.26051

2. Taylor BV, Gross L, Windebank AJ: The sensitivity and specificity of anti-GM1 antibody testing. Neurology 1996;47:951-955

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 doi: 10.1093/glycob/cwp027

Method Description
Describes how the test is performed and provides a method-specific reference

Antiganglioside 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 antihuman IgG or IgM antibodies (ie, secondary) 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 serum is greater than 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)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Tuesday, Thursday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

5 to 8 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

28 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

83516 x 6

83520 x 6 (if applicable)

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
GM1B Ganglioside Ab Panel, S 82455-7
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
4414 IgG Asialo. GM1 63212-5
4416 IgG Disialo. GD1b 94868-7
4412 IgG Monos. GM1 63243-0
4415 IgM Asialo. GM1 63384-2
4417 IgM Disialo. GD1b 94870-3
4413 IgM Monos. GM1 63247-1

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports