Test Id : FINA
NAbFeron (IFNB-1) Neutralizing Antibody Test
    
        Method Name
            
                
                
                    
                    A short description of the method used to perform the test
                
            
    
    Viral Cytopathic Effect Assay
    
        NY State Available
            
                
                
                    
                    Indicates the status of NY State approval and if the test is orderable for NY State clients.
                
            
    
    
    
        Reporting Name
            
                
                
                    
                    Lists a shorter or abbreviated version of the Published Name for a test
                
            
    
    
    
        Aliases
            
                
                
                    
                    Lists additional common names for a test, as an aid in searching
                
            
    
    Interferon B-1 FORWARD
Interferon Beta-1 FORWARD
    
        Specimen Type
            
                
                
                    
                    Describes the specimen type validated for testing
                
            
    
        Serum
    
        Specimen Required
            
                
                
                    
                    Defines the optimal specimen required to perform the test and the preferred volume to complete testing
                
            
    
    Patient Preparation: Specimen should be collected either before treatment with interferon or more than 24 hours following the most recent dose. Patient should not be on steroid therapy for at least two weeks prior to testing.
Collection Container/Tube: Red top or serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 2 mL serum
Collection Instructions:
1. Within 48 hours of collection, centrifuge and aliquot 2 mL of serum into a plastic vial.
2. Send refrigerate.
    
        Specimen Minimum Volume
            
                
                
                    
                    Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
                
            
    
    Serum: 0.5 mL
    
        Reject Due To
            
                
                
                    
                    Identifies specimen types and conditions that may cause the specimen to be rejected
                
            
    
    
    
        Specimen Stability Information
            
                
                
                    
                    Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
                
            
    
    | Specimen Type | Temperature | Time | Special Container | 
|---|---|---|---|
| Serum | Refrigerated (preferred) | 28 days | |
| Ambient | 72 hours | ||
| Frozen | 180 days | 
    
        Clinical Information
            
                
                
                    
                    Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
                
            
    
    Refer to www.athenadiagnostics.com/view-full-catalog
    
        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.
                
            
    
    <1:20
    
        Cautions
            
                
                
                    
                    Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
                
            
    
    The present of neutralizing antibodies to interferon beta, especially in persistently high titers, may be associated with reduction in the clinical effectiveness of interferon beta therapy.(1) Although the measurement of Nabs can add to the clinical and imaging information used to assess the efficacy of interferon beta therapy, these results should be interpreted in the context of clinical presentation and medical history.(2,3)
Although rare, false positive or false negative results may occur. All results should be interpreted in the context of clinical findings, relevant history, and other laboratory data.
    
        Clinical Reference
            
                
                
                    
                    Recommendations for in-depth reading of a clinical nature
                
            
    
    1. Goodin DS, Frohman EM, Hurwitz B, et al. Neutralizing antibodies to interferon beta: assessment of their clinical and radiographic impact: an evidence report: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2007;68(13):977-984
2. Polman CH, Bertolotto A, Deisenhammer F, et al. Recommendations for clinical use of data on neutralising antibodies to interferon-beta therapy in multiple sclerosis. Lancet Neurol. 2010;9(7):740-750
3. Creeke Pl, Farrell RA. Clinical testing for neutralizing antibodies to interferon-ß in multiple sclerosis. Ther Adv Neurol Disord. 2013;6(1):3-17
    
        PDF Report
            
                
                
                    
                    Indicates whether the report includes an additional document with charts, images or other enriched information
                
            
    
    
    
        Day(s) Performed
            
                
                
                    
                    Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
                
            
    
    Monday through Friday
    
        Report Available
            
                
                
                    
                    The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
                
            
    
    
    
        Performing Laboratory Location
            
                
                
                    
                    Indicates the location of the laboratory that performs the test
                
            
    
    
    
        Fees :
            
                
                
                    
                    Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
                
            
    
    - Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. For assistance, contact Customer Service.
    
        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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
                
            
    
    This test was developed and its analytical performance characteristics have been determined by Athena Diagnostics. It has not been cleared or approved by U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes. .
    
        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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
                
            
    
    CPT codes are provided by the performing laboratory.
86382
    
        LOINC® Information
            
                
                
                    
                    Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
                
            
    
    | Test Id | Test Order Name | Order LOINC Value | 
|---|---|---|
| FINA | NAbFeron (IFN-B) Antibody | Not Provided | 
| Result Id | Test Result Name | Result LOINC Value 
                                        
                                        Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
                                     | 
|---|---|---|
| Z0083 | NAbFeron (IFN-B) Antibody | Not Provided |