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Test ID: MSP3 Multiple Sclerosis (MS) Profile, Serum and Spinal Fluid


Specimen Required


Both serum and spinal fluid are required. Spinal fluid must be obtained within 1 week of serum collection.

 

Specimen Type: Spinal fluid

Container/Tube: Sterile vial

Specimen Volume: 1 mL

Collection Instructions: Label specimen as spinal fluid.

 

Specimen Type: Serum

Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 1 mL

Collection Instructions: Label specimen as serum.


Useful For

Diagnosing multiple sclerosis, especially helpful in patients with equivocal clinical or radiological findings

Profile Information

Test ID Reporting Name Available Separately Always Performed
KCSFP Kappa Free Light Chain, CSF Yes, (KCSF) Yes
XSRM Additional sample for reflex OLIGS No Yes

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
OLIGS Serum Bands Yes, (Order OLIG, submit CSF and Serum) No
OLIGC CSF Bands Yes, (Order OLIG, submit CSF and Serum) No

Testing Algorithm

Kappa free light chain will be performed by nephelometry on all samples. When kappa free light chain results are greater than 0.0600 mg/dL, oligoclonal band testing for will be performed at an additional charge. If the testing exceeds the specimen stability for oligoclonal band testing only kappa free light chain will be performed. Kappa free light chain will only be performed up to specimen stability.

Method Name

KCSFP: Nephelometry

OLIGC, OLIGS: Isoelectric Focusing (IEF) with IgG Immunoblot Detection

Reporting Name

Multiple Sclerosis Profile

Specimen Type

CSF
Serum

Specimen Minimum Volume

Serum, Spinal fluid: 0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
CSF Frozen (preferred) 14 days
  Refrigerated  72 hours
  Ambient  24 hours
Serum Frozen (preferred) 14 days
  Ambient  14 days
  Refrigerated  14 days

Clinical Information

Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease characterized by visual, motor, and sensory disturbances. The diagnosis of MS is dependent on clinical, radiological, and laboratory findings. The detection of increased intrathecal immunoglobulin (Ig) synthesis is the basis for current diagnostic laboratory tests for MS. These tests include the kappa free light chains in cerebrospinal fluid (CSF) and CSF oligoclonal band detection.

Reference Values

KAPPA FREE LIGHT CHAIN

Medical Decision Point: 0.1000 mg/dL

 

OLIGOCLONAL BANDS:

<2 bands

Interpretation

When result is greater than or equal to 0.1000 mg/dL, the kappa free light chain concentration measured in cerebrospinal fluid (CSF) is at or greater than the threshold associated with demyelinating disease. This is a positive result. These findings, however, are not specific for multiple sclerosis (MS) because CSF-specific immunoglobulin synthesis may also be detected in patients with other neurologic diseases (infectious, inflammatory, cerebrovascular, autoimmune, and paraneoplastic). Clinical correlation is recommended. Automatic reflexing to oligoclonal bands will occur.

 

When result is less than 0.0600 mg/dL, the kappa free light chain concentration measured in CSF is lower than the threshold associated with demyelinating disease. This is a negative result. Testing for oligoclonal banding is not performed. Clinical correlation is recommended.

 

When result is between 0.0600 and 0.1000 mg/dL, the kappa free light chain concentration measured in CSF is  slightly elevated but not above the medical decision point of 0.1000 mg/dL associated with demyelinating disease. This is a borderline result. Reflexing to oligoclonal bands will be automatically performed and clinical correlation is recommended.

 

When the oligoclonal band assay detectss 2 or more unique IgG bands in the CSF, the result is positive.

 

CSF is used in the diagnosis of multiple sclerosis (MS) by identifying increased intrathecal IgG synthesis qualitatively (oligoclonal bands). The presence of 2 or more unique CSF oligoclonal bands was reintroduced as one of the diagnostic criteria for MS in the 2017 revised McDonald criteria. These findings, however, are not specific for MS as CSF-specific IgG synthesis may also be found in patients with other neurologic diseases including infectious, inflammatory, cerebrovascular, and paraneoplastic disorders. Clinical correlation is recommended.

Clinical Reference

1. Andersson M, Alvarez-Cermeno J, Bernardi G, et al: Cerebrospinal fluid in the diagnosis of multiple sclerosis: a consensus report. J Neurol Neurosurg Psychiatry 1994 Aug;57(8):897-902

2. Tourtellotte WW, Walsh MJ, Baumhefner RW, et al: The current status of multiple sclerosis intra-blood-brain-barrier IgG synthesis. Ann NY Acad Sci 1984;436:52-67

3. Thompson AJ, Banwell BL, Barkhof F, et al: Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. The Lancet Neurology 2018 Feb;17(2):162-173

4. Gurtner KM, Shosha E, Bryant SC, et al: CSF free light chain identification of demyelinating disease: comparison with oligoclonal banding and other CSF indexes. Clin Chem Lab Med 2018;56:1071-1080

5. Saadeh R, Pittock S, Bryant S, et al: CSF Kappa Free Light Chains as a Potential Quantitative Alternative to Oligoclonal Bands in Multiple Sclerosis. In American Academy of Neurology Annual Meeting. 2019 Philadelphia, PA

Day(s) and Time(s) Performed

Monday through Friday; 7 a.m.-12 p.m.

Analytic Time

3 days

Test Classification

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

83883

83916 x2 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
MSP3 Multiple Sclerosis Profile 55121-8

 

Result ID Test Result Name Result LOINC Value
KCSFP Kappa Free Light Chain, CSF 48774-4
XSRM Additional sample for Reflex OLIGS No LOINC Needed

Forms

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