Test ID: MSP2
Multiple Sclerosis (MS) Profile
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Diagnosing multiple sclerosis, especially helpful in patients with equivocal clinical or 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 |
|---|---|---|---|
| OLIGC | CSF Bands | No | Yes |
| OLIGS | Serum Bands | No | Yes |
| SFINC | IgG Index, CSF | No | Yes |
| SFINS | IgG, S | Yes, (order IGG) | Yes |
Method Name A short description of the method used to perform the test
OLIGC/3484, OLIGS/2783: Isoelectric Focusing (IEF) with IgG Immunoblot Detection
SFINC/2762, SFINS/2763: Nephelometry
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Cerebrospinal Fluid (CSF) IgG Index
CSF (Cerebrospinal Fluid) Index
CSF (Cerebrospinal Fluid), Specific Protein IgG (Immunoglobulin G), Albumin
Electrophoresis, Spinal Fluid
IgG (Immunoglobulin G)
IgG (Immunoglobulin G) Index
IgG (Immunoglobulin G) Synthesis Rate
Immunoglobulin G (IgG)
Multiple Sclerosis (MS)
Oligoclonal Banding
Specimen Type Describes the specimen type needed for testing
Serum
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
Container/Tube: Red top or serum gel
Specimen Volume: 1 mL
Collection Instructions: Label specimen as serum.
Specimen Type: Spinal fluid
Container/Tube: Sterile vial
Specimen Volume: 1 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.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | CSF: NA Serum: Mild OK; Gross OK |
| Lipemia | CSF: NA Serum: Mild OK; Gross reject |
| Icterus | CSF: NA Serum: Mild OK; Gross OK |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| CSF | Refrigerated (preferred) | 14 days |
| Ambient | 14 days | |
| Frozen | 14 days | |
| Serum | Refrigerated (preferred) | 14 days |
| Ambient | 14 days | |
| Frozen | 14 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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 cerebrospinal fluid (CSF) IgG index and CSF oligoclonal band detection.
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.
OLIGOCLONAL BANDS
<4 bands
CSF INDEX
CSF IgG index: 0.00-0.85
CSF IgG: 0.0-8.1 mg/dL
CSF albumin: 0.0-27.0 mg/dL
Serum IgG
0-4 months: 100-334 mg/dL
5-8 months: 164-588 mg/dL
9-14 months: 246-904 mg/dL
15-23 months: 313-1,170 mg/dL
2-3 years: 295-1,156 mg/dL
4-6 years: 386-1,470 mg/dL
7-9 years: 462-1,682 mg/dL
10-12 years: 503-1,719 mg/dL
13-15 years: 509-1,580 mg/dL
16-17 years: 487-1,327 mg/dL
> or =18 years: 767-1,590 mg/dL
Serum albumin: 3,200-4,800 mg/dL
CSF IgG/albumin: 0.0-0.21
Serum IgG/albumin: 0.00-0.40
CSF IgG synthesis rate: 0-12 mg/24 hours
Interpretation Provides information to assist in interpretation of the test results
Oligoclonal banding (OCB): > or =4 cerebrospinal fluid (CSF)-specific bands are consistent with multiple sclerosis (MS).
CSF IgG index: >0.85 is consistent with MS.
Abnormal CSF IgG indexes and OCB patterns have been reported in 70% to 80% of MS patients. If both tests are performed, at least 1 of the tests has been reported to be positive in >90% of multiple sclerosis patients. A newer methodology for OCB detection, isoelectric focusing, is utilized in this test and has been reported to be more sensitive (90%-95%).
The presence of OCB or elevated CSF IgG index 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
Increased intrathecal Ig synthesis may occur in other inflammatory central nervous system diseases and, therefore, these assays are not specific for multiple sclerosis (specificity=95%).
Supportive Data
In early 2003, we compared the IEF oligoclonal banding (OCB) assay to our previous high-resolution agarose OCB assay, as well as the cerebrospinal fluid (CSF) IgG index. The IEF assay requires a smaller specimen volume and is easier to interpret than the agarose assay. Concordant normal samples usually had 0 bands by IEF, but 1 band by agarose. The concordant positive samples had an average of 11 bands by IEF and 2 bands on agarose. Among 19 cases of definite multiple sclerosis (MS), the IEF 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 assay had a specificity of 95% and the agarose and CSF index assays had specificities of 97%. These data indicate a 32% increase in sensitivity and a 2% decrease in specificity for the IEF OCB assay.
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 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
Method Description Describes how the test is performed and provides a method-specific reference
The oligoclonal banding (OCB) assay requires paired cerebrospinal fluid (CSF) and serum samples. Unconcentrated CSF and diluted serum are electrophoresed by isoelectric focusing. The separated Ig are visualized by an IgG immunoblot, and oligoclonal bands 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 immunoglobulin G: an annotated update. Ann Clin Biochem 1990 September;27[5]:436-443)
The CSF IgG index also requires paired CSF and serum samples. The CSF and serum IgG and albumin are determined by immunonephelometry on a Siemens Nephelometer II. The CSF IgG index and synthesis rate are calculated and reported. In addition, the serum IgG and albumin, CSF IgG and albumin, and serum and CSF IgG/albumin ratios are reported. (Markowitz H, Kokmen E: Neurologic diseases and the cerebrospinal fluid immunoglobulin profile. Mayo Clin Proc 1983 April;58[4]:273-274; Siemens Nephelometer II Operators Manual 1999)
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; 7 a.m. - 12 p.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.
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.
82040-Albumin, serum
82042-Albumin, spinal fluid
82784 x 2-IgG, serum and spinal fluid
83916-Oligoclonal band, spinal fluid
83916-Oligoclonal band, serum (if appropriate)
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 |
|---|---|---|
| 2783 | Serum Bands | 35569-3 |
| INDEX | IgG Index, CSF | 14117-6 |
| 8017 | CSF Bands | 12782-9 |
| IGG_S | IgG, S | 2465-3 |
| ALB_S | Albumin, S | 1751-7 |
| 23611 | CSF Olig Bands Interpretation | 12782-9 |
| IGG_C | IgG, CSF | 2464-6 |
| ALB_C | Albumin, CSF | 1746-7 |
| AIGAS | IgG/Albumin, S | 6782-7 |
| AIGAC | IgG/Albumin, CSF | 2470-3 |
| SRATE | Synthesis Rate, CSF | 14116-8 |
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