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Endomysial IgG Antibody Screen and Titer
Test Code91985
CPT Codes
86231 <br /> ** This test is not available for New York patient testing **
Includes
Endomysial IgG Titer will report when the titer is ≥2.5 (CPT code(s): 86231)
Preferred Specimen
2 mL serum
Minimum Volume
0.3 mL
Instructions
Allow the blood to clot in an upright position for at least 30 minutes but not longer than 1 hour before centrifugation. Centrifuge for at least 15 minutes at 2200-2500 RPM at room temperature within one hour of collection, store at -20° C, and send 2 mL of serum frozen in a plastic vial.
Transport Temperature
Frozen
Specimen Stability
Room temperature: 48 hours
Refrigerated: 14 days
Frozen: 30 days
Refrigerated: 14 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Lipemia • Microbially contaminated specimens • Specimens recieved outside of stability
Methodology
Immunofluorescence Assay (IFA)
FDA Status
The performance characteristics of the listed assay was validated by BioAgilytix Diagnostics. The US FDA has not approved or cleared this test. The results of this assay can be used for clinical diagnosis without FDA approval. BioAgilytix Diagnostics is a CLIA certified, CAP accredited laboratory for performing high complexity assays such as this one.
Setup Schedule
Sets up 5 days a week.
Clinical Significance
Serological methods of detecting Immunoglobulin A (IgA) antibodies to gliadin, endomysium (EMA), reticulin, and tissue transglutaminase are routinely used for diagnosing both symptomatic and asymptomatic patients with Celiac Disease (CD). Since Immunoglobulin A (IgA) deficiency is 10 to 15 times more common in patients with Celiac Disease than in healthy subjects, IgG-specific antibody tests for endomysium are useful for the identification of IgA-deficient patients with CD.
