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 BandingUseful 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 RochesterSpecimen Type
CSFSerum
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)