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Test Code TS IMMUNOG Thyroid-Stimulating Immunoglobulin (TSI), Serum

Reporting Name

Thyroid-Stimulating Immunoglob, S

Useful For

Second-order testing for autoimmune thyroid disease, including:

-Differential diagnosis of etiology of thyrotoxicosis in patients with ambiguous clinical signs or contraindicated (eg, pregnant or breast-feeding) or indeterminate thyroid radioisotope scans

-Diagnosis of clinically suspected Graves disease (eg, extrathyroidal manifestations of Graves disease: endocrine exophthalmos, pretibial myxedema, thyroid acropachy) but normal thyroid function tests

-Determining the risk of neonatal thyrotoxicosis in a fetus of a pregnant female with active or past Graves disease

-Differential diagnosis of gestational thyrotoxicosis versus first-trimester manifestation or recurrence of Graves disease

-Assessing the risk of Graves disease relapse after antithyroid drug treatment

 

A combination of TSI / Thyroid-Stimulating Immunoglobulin (TSI), Serum and THYRO / Thyrotropin Receptor Antibody, Serum is useful as an adjunct in the diagnosis of unusual cases of hypothyroidism (eg, Hashitoxicosis).


Specimen Required


Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 0.5 mL


Seattle Children's Hospital Note:

Collect 1.0 mL whole blood in a Red top.

Specimen Type

Serum

Specimen Minimum Volume

0.1 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Frozen (preferred) 60 days
  Refrigerated  7 days
  Ambient  24 hours

Day(s) and Time(s) Performed

Monday through Friday; 10 a.m.

Seattle Children's Hospital Note:

TAT: 4 - 8 days

Performing Laboratory

Mayo Medical Laboratories in Rochester

Method Name

Recombinant Bioassay

Method Description

This bioassay compares the cyclic adenosine monophosphate (cAMP) production of thyroid-stimulating hormone (TSH)-responsive cells upon exposure to patient serum with that obtained in the same cells after exposure to normal control serum.

 

The assay uses Chinese hamster ovary cells that have been permanently transfected with the human thyroid-stimulating hormone receptor (TSHR) and a luciferase expression construct under the control of a cAMP responsive promoter. Luciferase transcription in these cells is proportional to the concentration of intracellular cAMP.

 

The cells are grown to near-confluence. An aliquot of cells is then incubated with each diluted patient serum. Cells are lysed at the end of incubation, luciferase substrate is added and chemiluminescence is measured in a luminometer. The ratio of the light-units produced in the cell-lysate exposed to patient serum divided by a control cell-lysate light-signal is the TSI index.(Preissner CM, Wolhuter PJ, Sistrunk JW, et al: Comparison of thyrotropin-receptor antibodies measured by four commercially available methods with a bioassay that uses Fisher-rat thyroid cells. Clin Chem 2003;49:1402-1404; package insert: Thyroid Stimulating Immunoglobulin Assay. Diagnostic Hybrids)

Reference Values

≤1.3 TSI index

Reference values apply to all ages.

Test Classification

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

84445

LOINC Code Information

Test ID Test Order Name Order LOINC Value
TSI Thyroid-Stimulating Immunoglob, S 30567-2

 

Result ID Test Result Name Result LOINC Value
8634 Thyroid-Stimulating Immunoglob, S 30567-2

Reject Due To

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross OK

Icterus

Mild OK; Gross OK

Other

NA

Forms

If not ordering electronically, complete, print, and send a General Request Form (T239) with the specimen (http://www.mayomedicallaboratories.com/it-mmfiles/general-request-form.pdf).