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Test Code SOFT: ZG111 Oligoclonal Banding, Serum and Spinal Fluid

Additional Codes

Ordering Mnemonic Soft ID Test
EPIC NAME: CSF OLIGOCLONAL BANDING ZG111

EPIC CODE: LAB740

 

 

 

Reporting Name

Oligoclonal Banding

Useful For

Diagnosis of multiple sclerosis; especially useful in patients with equivocal clinical presentation and radiological findings

Profile Information

Test ID Reporting Name Available Separately Always Performed
OLIGS Serum Bands No Yes
OLIGC CSF Bands No Yes

Method Name

Isoelectric Focusing (IEF) with IgG Immunoblot Detection

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

CSF
Serum


Specimen Required


Both serum and spinal fluid are required. Spinal fluid must be obtained within 7 days of serum collection.

 

Specimen Type: Serum

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

1. Centrifuge and aliquot serum into a plastic vial within 2 hours of collection.

2. Label specimen as serum.

 

Specimen Type: Spinal fluid

Container/Tube: Sterile vial

Specimen Volume: 0.5 mL

Collection Instructions: Label specimen as spinal fluid.


Specimen Minimum Volume

Serum, Spinal Fluid: 0.4 mL

Specimen Stability Information

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

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Reference Values

CSF Oligoclonal Bands Interpretation: <2 bands

Day(s) Performed

Monday through Friday

CPT Code Information

83916 x 2

LOINC Code Information

Test ID Test Order Name Order LOINC Value
OLIG Oligoclonal Banding 100757-4

 

Result ID Test Result Name Result LOINC Value
8017 CSF Bands 49852-7
2783 Serum Bands 100755-8
23611 CSF Olig Bands Interpretation 100756-6

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

Clinical Information

The diagnosis of multiple sclerosis (MS) is dependent on clinical, radiological, and laboratory findings. The detection of increased intrathecal immunoglobulin synthesis is the basis for current diagnostic laboratory tests for MS. These tests include the measurement of kappa free light chains in cerebrospinal fluid (CSF) and CSF oligoclonal band (OCB) detection. Abnormal CSF OCB patterns have been reported in 70% to 80% of MS patients.

 

Increased intrathecal Ig synthesis may occur in other inflammatory CSF diseases and, therefore this assay is not specific for MS.

Interpretation

When the oligoclonal band assay detects 2 or more unique IgG bands in the cerebrospinal fluid (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 recommended.

Cautions

This test is not specific for multiple sclerosis.

Supportive Data

In a cohort of 1307 patients analyzed in 2018, where 159 had demyelinating disease, the Mayo Clinic oligoclonal banding test had a clinical sensitivity of 74% and clinical specificity of 89%, with a ROC AUC of 0.813 when 2 or more unique cerebrospinal fluid bands are used as a cutoff for positive.

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. Fortini AS, Sanders EL, Weinshenker BG, Katzmann JA: Cerebrospinal fluid oligoclonal bands in the diagnosis of multiple sclerosis. Isoelectric focusing with the IgG immunoblotting compared with high resolution agarose gel electrophoresis and cerebrospinal fluid IgG index. Am J Clin Pathol. 2003 Nov:120(5):672-675

3. Thompson AJ, Banwell BL, Barkhof F, et al: Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 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 Jun 27;56(7):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. Neurology. 2019 April 09; 2019:92

Method Description

The oligoclonal band (OCB) assay requires paired cerebrospinal fluid (CSF) and serum samples. Unconcentrated CSF and diluted serum are electrophoresed by isoelectric focusing. The separated immunoglobulins (Ig) are visualized by an IgG immunoblot, and OCBs that are present in the CSF and not in the serum are reported. The assay uses reagents from Helena Laboratories.(Keir G, Luxton RW, Thompson EJ: Isoelectric focusing of cerebrospinal fluid immunoglobulins G: an annotated update. Ann Clin Biochem 1990;27:436-443; Hortin GL: Amino Acids, Peptides, and Proteins. In: Burtis CA, Bruns DE, eds. Tietz Fundamentals of Clinical Chemistry and Molecular Diagnostics. 7th ed. Elsevier; 2015:chap 18)

Report Available

2 to 4 days

Specimen Retention Time

14 days

Secondary ID

8017