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LAB TEST CONNECT Thyroid Stimulating Hormone Receptor Antibody Testing (TRAb) for Graves Disease David Corwin, M.D. and Joel Adams, MLS (ASCP) CM CLINICAL APPLICATION Thyroid Stimulating Hormone Receptor Antibody (TRAb) is useful for the differential diagnosis of clinically suspected Graves’ disease. TRAb can be used in the differential diagnosis of thyrotoxicosis in patients with nondiagnostic clinical findings or thyroid radioisotope scans. Additional applications for TRAb are in determining the risk of neonatal thyrotoxicosis in a fetus of a pregnant female with active or past active Graves’ disease, differential diagnosis of gestational thyrotoxicosis and assessing the risk of Graves’ disease relapse after antithyroid drug treatment. The TRAb test can also be used in the differential diagnosis of toxic nodular goiter, thyroid cancer, thyrotoxicosis factitia, viral subacute thyroiditis, pituitary tumor, and head and neck cancer. CLINICAL BACKGROUND Graves disease is an autoimmune disorder, caused by the production of thyroid autoantibodies that activate the TSH-receptor. The antibodies stimulate thyroid hormone production that is not inhibited by the usual feedback mechanism, leading to hyperthyroidism and thyrotoxicosis. Graves disease is the most common cause of hyperthyroidism and comprises 60-90% of all cases. The condition usually presents itself during midlife, but also appears in children, adolescents, and the elderly. It affects up to 2% of the female population, and is more common in females than in males. CLINICAL MANAGEMENT Treatments for Graves disease do not affect the underlying autoimmune disease process, but are designed to ablate thyroid tissue or block thyroid hormone synthesis. Symptom relief is usually not immediate, but can be achieved over time as the treatments take effect and thyroid levels return to normal. www.paml.com ORDER CODE: ATSHR Quick Facts nThe prevalence of hyperthyroidism is approximately 2-3% of the general population. nThe majority of cases of hyperthyroidism are a consequence of Graves’ disease. nThe hyperthyroidism of Graves disease is caused by autoantibodies which stimulate TSH receptors. nDetection of TSH receptor antibodies (TRAb) can aid in the differential diagnosis of Graves’ disease when combined with clinical findings. nThe TRAb assay shows 85% sensitivity and 100% specificity for identifying patients with Graves’ disease. nThe TRAb assay has a shorter turn-around time, less analytical variability and is less expensive than the cell culture bioassay for thyroid-stimulating immunoglobulins. Thyroid Stimulating Hormone Receptor Antibody Testing-PAML-TSHR_0001 ©2016 PAML, LLC — V2 REV121916 Thyroid Stimulating Hormone Receptor Antibody Testing (TRAb) for Graves Disease TEST INFORMATION THYROID STIMULATING HORMONE RECEPTOR ANTIBODY TRAB TEST CODE ATSHR BILLING CODE ATSHR SYNONYMS CONTAINER TYPE SUPPLY ITEM NUMBER STORE AND TRANSPORT SPECIMEN TYPE PREFERRED VOLUME MINIMUM VOLUME TRAb, TBII, Anti-Thyrotropin, Anti-TSHR, Thyrotropin Receptor Antibody, TSH Receptor Antibody, TSH Receptor Blocking Antibody, Thyroid Stimulating Hormone Receptor Antibody Serum separator tube (gold, brick, SST, or corvac) 1467 Store and transport frozen. Separate samples must be submitted when multiple tests are ordered Serum, Frozen 1.0 mL 0.30 mL COLLECTION PROCEDURE Collect 4 mL blood in a serum separator tube SPECIMEN PROCESSING Separate serum from cells and transfer to a standard PAML aliquot tube and freeze ROOM TEMP 1 day REFRIGERATED FROZEN -20C UNACCEPTABLE CONDITION DEPARTMENT CPT CODES TEST SCHEDULE TURNAROUND TIME METHOD TEST INCLUDES REFERENCE RANGES CLINICAL SIGNIFICANCE 3 days 1 month Plasma samples; grossly hemolyzed or lipemic serum specimens ; samples from patients on heparin therapy; heat-inactivated samples; samples stabilized with azide PAML Special Immunology 83520 Tue., Thu., Sat. 2-4 days Quantitative Electrochemiluminescent Immunoassay TSH Receptor Antibody TSH Receptor Antibody IU/L LT 1.76 Positive results are consistent with autoimmune thyroid disease. SELECTED REFERENCES 1. 2. 3. 4. Package Insert: KRONUS TSH Receptor Antibody (TRAb) ELISA Kit, Manufactured by KRONUS, 170 S. Seneca Springs Way, Suite 105, Star, ID 83669 USA P/N 196c v.02/11 Lab Tests Online. Graves Disease. http://labtestsonline.org/understanding/conditions/graves/ American Thyroid Association. Graves Disease. http://www.thyroid.org/what-is-graves-disease/ National Endocrine and Metabolic Diseases Information Service. Graves Disease. http://www.endocrine.niddk.nih.gov/pubs/graves/ For more information, please contact your local sales representative.