Test Code Billings Clinic: 4865 Sulfatide Autoantibody Test, Athena #210
Performing Laboratory
Athena Diagnostics, Inc.
Methodology
Enzyme-Linked Immunosorbent Assay (ELISA)
Specimen Requirements
- Draw blood in a plain, red-top tube(s).
- Serum gel tube is acceptable.
- Spin down and send 2 mL (minimum volume: 1 mL) of serum refrigerated.
Reference Values
Interpretation and comments provided on each report. Interpretation and comments vary. They are dependent upon results.
Immunoglobulin Isotype | Normal |
Mild/ Moderate Elevated |
Highly Elevated |
IgM | <1,500 | ≥1,500 | Not applicable |
IgG | <1,500 | ≥1,500 | Not applicable |
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) Test Set Up
Tuesday, Thursday, Sunday
Test Classification and CPT Coding
Test Classification:
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 standards of the Clinical and Laboratory Standards Institute (CLSI) criteria.
CPT Code:
83520 x 4 - immunoassay, analyte, quantitative; not otherwise
specified
83912 - interpretation and report