Oligoclonal Banding, Serum and Spinal Fluid
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Diagnosis of multiple sclerosis; especially useful in patients with equivocal clinical presentation and radiological findings
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|
Isoelectric Focusing (IEF) with IgG Immunoblot Detection
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
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.
Serum and spinal fluid are required. Spinal fluid must be obtained within 1 week of serum draw.
Specimen Type: Serum
Preferred: Serum gel
Acceptable: Red top
Specimen Volume: 0.5 mL
Collection Instructions: 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 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.
Serum: 0.4 mL/Spinal Fluid: 0.4 mL
Mild OK; Gross OK
Mild OK; Gross OK
Mild OK; Gross OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|CSF||Refrigerated (preferred)||14 days|
|Serum||Refrigerated (preferred)||14 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
The diagnosis of multiple sclerosis (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 cerebrospinal fluid (CSF) IgG index and CSF oligoclonal band (OCB) detection. Abnormal CSF IgG indexes and OCB patterns have been reported in 70% to 80% of MS patients. At least 1 of these tests has been reported to be positive in 90% of MS patients when both test are performed.
Newer methodologies for OCB detection have been reported to be more sensitive, with sensitivities of 90% to 95% in CSF from MS patients.
Increased intrathecal Ig synthesis may occur in other inflammatory CSF diseases and, therefore, this assay is not specific for MS (specificity = 95%).
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.
CSF Olig Bands Interpretation: <4 bands
A finding of 4 or more cerebrospinal fluid (CSF)-specific bands (ie, bands that are present in CSF but are absent in serum) is consistent with multiple sclerosis.
The presence of oligoclonal band is unrelated to disease activity.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
These tests are not specific for multiple sclerosis.
In early 2003 we compared the isoelectric focusing (IEF) assay to our previous high-resolution agarose assay as well as the cerebrospinal fluid (CSF) IgG index. The IEF assay requires a smaller volume of CSF and is easier to interpret than the agarose assay. Concordant normal specimens usually had zero bands by IEF but 1 band by agarose. The concordant positive specimens had an average of 11 bands by IEF and 2 bands on agarose.
Among 19 cases of definite multiple sclerosis (MS), the IEF oligoclonal band (OCB) assay had a sensitivity of 95%, the agarose assay had a sensitivity of 63%, and the CSF index had a sensitivity of 74%. Among 57 consecutive non-MS cases, the IEF OCB assay had a specificity of 95% and agarose and CSF index assays had a specificity of 97%. These data demonstrated a 32% increase in sensitivity and a 2% decrease in specificity for IEF.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
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;57:897-902
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 2003:120:672-675
Method Description Describes how the test is performed and provides a method-specific reference
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 immunoglobulin (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)
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 through Saturday; 8 a.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.
This test has been cleared or approved by the U.S. 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.
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.
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|
|23611||CSF Olig Bands Interpretation||12782-9|