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Test ID: FSULF
Sulfatide Autoantibody Test

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

90072

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

Yes

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

Enzyme-Linked Immunosorbent Assay (ELISA)

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

Sulfatide Autoantibody Test

Aliases Lists additional common names for a test, as an aid in searching

Sulfatide Autoantibody Test FORWARD

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 a plain, red-top tube(s). (Serum gel tube is

acceptable.) Spin down and send 2 mL of serum ambient.

 

Note: 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.

1.0 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
SerumAmbient (preferred)
 Refrigerated 

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.

Interpretive Criteria

Interpretation and Comments provided on each report.

Interpretation and Comments vary.  They are dependent upon

results.

 

Reference Range:

Immunoglobin                             Mild/Moderate

     Isotype               Normal            Elevated            Highly Elevated

        IgM                   < 1500             > or = 1500            Not applicable

        IgG                   < 1500             > or = 1500            Not applicable

 

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. Pestronk, A. et al. Neurology 1991; 41:357-363

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

Methods:

Detection of sulfatide autoantibodies was determined by the

evaluation of IgM antibodies to histone and sulfatide

antigens individually.  Sulfatide specific autoantibodies

to IgG were evaluated by analysis with GM1 and sulfatide

antigens each.  All analyses were performed by ELISA

methodology, analytical values were reviewed to establish

a serological profile in order to determine the conclusive

diagnostic results.

This testing service is covered by U.S. Patent Number 5,443,952.

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.

Sunday, Tuesday, Thursday

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

16 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

12 months

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 investig- ational or for research only. Athena Diagnostics is licensed under the Clinical Laboratory Improvement Amend- ments 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 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.

83520/x2 Immunoassay, analyte, quant; not otherwise specified

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
Z0079Sulfatide ELISA IgM TiterIn Process
Z0080SpecificityIn Process
Z0078Sulfatide ELISA IgG TiterIn Process
Z0081SpecificityIn Process
Z0074Interpretive CriteriaIn Process