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Test ID: FINA
NAbFeron (IFN-B) Neutralizing Antibody

Secondary ID A test code used for billing and in test definitions created prior to November 2011

91447

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Useful For Suggests clinical disorders or settings where the test may be helpful

Detection of antibodies to interferon-B-1

Method Name A short description of the method used to perform the test

Viral cytopathic effect assay

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

NAbFeron (IFN-B) Antibody

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.

Draw blood in plain red top tube. Separate and send 2 mL of serum refrigerated. (Serum gel tube is acceptable.)

Note: 1.Sample needs to 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.

2. Collection date is required.

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.

1 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Specimens other than

Serum

Anticoagulants other than

NA

Hemolysis

NA

Thawing

NA

Lipemia

NA

Icteric

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 TypeTemperatureTime
SerumRefrigerated (preferred)14 days
 Ambient 72 hours

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.

Normal titer: <20

Mild/Moderate titer:  > or = 20 -  < or = 60

High titer: >60

  

Test Performed By: Athena Diagnostics

                             377 Plantation St.

                             Four Biotech Park

                             Worcester, MA  01605

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

  1. Grossberg et all. J Interferon Research 1988; 8: 5-7
  2. Grossberg et al. Biotherapy (in press) 1997
  3. Grossberg et al. In: Manual of Clinical Laboratory Immunology,1986 3rd ed. 295-299
  4. WHO Technical Report Series 687, 35-60, 1983
  5. Betaseron prescribing information, Berlex
  6. Rebif prescribing information, Serono
  7. AVONEX product insert, Biogen 1996
  8. Sibley et al. Neurology 1996; 47: 889-894
  9. Paty et al. Neurology 1996; 47: 865-866

Method Description Describes how the test is performed and provides a method-specific reference

The detection and neutralizing potency of antibodies to interferon in

Patient specimens were performed by an anti-viral bioassay. The

methodology follows the guidelines of the NIH Committee on Human

antibodies to Interferon (1) and the World Health Organization for the

standardization of interferon neutralization bioassays. (4) Specimens

were titrated against natural human fibroblast-derived beta interferon.

The titer is expressed as the reciprocal of the dilution of patient serum

which reduce interferon activity by a standard amount. (1) The Mild/

Moderately Elevated range reflects the analytical variation of antibody

immunoreactivity to beta interferons. (5)

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

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.

7 -14 days

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

8-15 days

Performing Laboratory Location The location of the laboratory that performs the test

Athena Diagnostics

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 was developed and its performance characteristics determined by Athena Diagnostics, Inc. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes and should not be regarded as investigational or for research only. Athena Diagnostics is licensed under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity clinical testing. Athena Diagnostics has performed assay validation studies and has developed its laboratory protocols and operating procedures in consultation with experts in the field and in accordance with the standards of the National Committee on Clinical Laboratory Standards (NCCLS).

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.

86382/Neutralization test, viral

87253/Tissue culture, additional studies or definitive identification

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 IDReporting NameLOINC Code
Z0083NAbFeron (IFN-B) AntibodyIn Process