Test Catalog

Test Id : STSH

Thyroid-Stimulating Hormone-Sensitive (s-TSH), Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Screening for thyroid dysfunction and detecting mild (subclinical), as well as overt, primary hypo- or hyperthyroidism in ambulatory patients

 

Monitoring patients on thyroid replacement therapy

 

Confirmation of thyrotropin (TSH, formerly thyroid-stimulating hormone) suppression in thyroid cancer patients on thyroxine suppression therapy

 

Prediction of thyrotropin-releasing hormone-stimulated TSH response

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Thyroid Function Ordering Algorithm in Special Instructions.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

Electrochemiluminescent Immunoassay

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

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

TSH, Sensitive, S

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

High Sensitivity-Thyroid Stimulating Hormone

HS-TSH (High Sensitivity Thyroid-Stimulating Hormone)

S-TSH (Sensitive-Thyroid-Stimulating Hormone)

Sensitive TSH (Thyroid-Stimulating Hormone)

Thyroid-Stimulating Hormone-Sensitive (S-TSH), Serum

Thyrotropin

TSH (Thyroid-Stimulating Hormone)-High Sensitivity

TSH Hypersensitive

TSH, 3rd Generation

TSH-ICMA

Ultra-Sensitive TSH (Thyroid Stimulating Hormone)

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Thyroid Function Ordering Algorithm in Special Instructions.

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

This is a standalone test for sensitive thyrotropin (s-TSH; formerly thyroid-stimulating hormone).

 

If a cascade approach is preferred, order THSCM / Thyroid Function Cascade, Serum, which utilizes a cascaded testing procedure to efficiently evaluate and monitor functional thyroid status. Serum s-TSH is the first-line test and when the s-TSH result is abnormal, appropriate follow-up tests will automatically be performed.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.6 mL

Collection Instructions:

1. Serum gel tubes should be centrifuged within 2 hours of collection.

2. Red-top tubes should be centrifuged and aliquoted within 2 hours of collection.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 7 days
Frozen 30 days
Ambient 7 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Screening for thyroid dysfunction and detecting mild (subclinical), as well as overt, primary hypo- or hyperthyroidism in ambulatory patients

 

Monitoring patients on thyroid replacement therapy

 

Confirmation of thyrotropin (TSH, formerly thyroid-stimulating hormone) suppression in thyroid cancer patients on thyroxine suppression therapy

 

Prediction of thyrotropin-releasing hormone-stimulated TSH response

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Thyroid Function Ordering Algorithm in Special Instructions.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Thyrotropin (TSH, formerly thyroid-stimulating hormone) is a glycoprotein hormone consisting of 2 subunits. The alpha subunit is similar to those of follicle-stimulating hormone, human chorionic gonadotropin, and luteinizing hormone. The beta subunit is different from those of the other glycoprotein hormones and confers its biochemical specificity.

 

TSH is synthesized and secreted by the anterior pituitary in response to a negative feedback mechanism involving concentrations of free triiodothyronine and free thyroxine. Additionally, the hypothalamic tripeptide, thyrotropin-releasing hormone, directly stimulates TSH production.

 

TSH interacts with specific cell receptors on the thyroid cell surface and gives rise to 2 main actions. First, it stimulates cell reproduction and hypertrophy. Second, it stimulates the thyroid gland to synthesize and secrete triiodothyronine and thyroxine.

 

Serum TSH concentrations exhibit a diurnal variation with the peak occurring during the night and the nadir occurring between 10 a.m. and 4 p.m. This biological variation does not influence the interpretation of the test result since most clinical TSH measurements are performed on ambulatory patients between 8 a.m. and 6 p.m.

 

When hypothalamic-pituitary function is normal, a log/linear inverse relationship between serum TSH and free thyroxine exists.

 

See Thyroid Function Ordering Algorithm in Special Instructions.

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.

0-5 days: 0.7-15.2 mIU/L

6 days-2 months: 0.7-11.0 mIU/L

3-11 months: 0.7-8.4 mIU/L

1-5 years: 0.7-6.0 mIU/L

6-10 years: 0.6-4.8 mIU/L

11-19 years: 0.5-4.3 mIU/L

> or =20 years: 0.3-4.2 mIU/L

 

For SI unit Reference Values, see https://www.mayocliniclabs.com/order-tests/si-unit-conversion.html

Interpretation
Provides information to assist in interpretation of the test results

In primary hypothyroidism, thyrotropin (TSH, formerly thyroid-stimulating hormone) levels will be elevated. In primary hyperthyroidism, TSH levels will be low.

 

The ability to quantitate circulating levels of TSH is important in evaluating thyroid function. It is especially useful in the differential diagnosis of primary (thyroid) from secondary (pituitary) and tertiary (hypothalamus) hypothyroidism. In primary hypothyroidism, TSH levels are significantly elevated, while in secondary and tertiary hypothyroidism, TSH levels are low or normal.

 

Elevated or low TSH in the context of normal free thyroxine is often referred to as subclinical hypo- or hyperthyroidism, respectively.

 

Thyrotropin-releasing hormone (TRH) stimulation differentiates all types of hypothyroidism by observing the change in patient TSH levels in response to TRH. Typically, the TSH response to TRH stimulation is exaggerated in cases of primary hypothyroidism, absent in secondary hypothyroidism, and delayed in tertiary hypothyroidism. Most individuals with primary hyperthyroidism have TSH suppression and do not respond to TRH stimulation with an increase in TSH over their basal value.

 

Sick, hospitalized patients may have falsely low or transiently elevated TSH.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Serum biotin concentrations up to 1200 ng/mL do not interfere with this assay. Concentrations up to 1200 ng/mL may be present in specimens collected from patients taking extremely high doses of biotin up to 300 mg per day.(1) In a study among 54 healthy volunteers, supplementation with 20 mg/day biotin resulted in a maximum serum biotin concentration of 355 ng/mL 1 hour post-dose.(2)

 

For assays employing antibodies, the possibility exists for interference by human anti-animal antibodies (ie, heterophile antibodies) in the patient specimen. Patients who have been regularly exposed to animals or have received immunotherapy or diagnostic procedures utilizing immunoglobulins or immunoglobulin fragments may produce antibodies (eg, human antimouse antibodies) that interfere with immunoassays. This may falsely elevate or falsely decrease the results.

 

Interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin, or ruthenium can occur.

 

For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Saint Paul LP, Debruyne D, Bernard D, Mock DM, Defer GL: Pharmacokinetics and pharmacodynamics of MD1003 (high-dose biotin) in the treatment of progressive multiple sclerosis. Expert Opin Drug Metab Toxicol. 2016;12(3):327-344. doi: 10.1517/17425255.2016.1136288.

2. Grimsey P, Frey N, Bendig G, et al: Population pharmacokinetics of exogenous biotin and the relationship between biotin serum levels and in vitro immunoassay interference. J Pharmacokinet Pharmacodyn. 2017;2(4),247-256

3.  Fatourechi V, Lankarani M, Schryver P, Vanness D, Hall-Long K, Klee G: Factors influencing clinical decisions to initiate thyroxine therapy for patients with mildly increased serum thyrotropin (5.1-10.0 mIU/L). Mayo Clin Proc. 2003 May;78(5):554-560

4. Wilson JD, Foster DW, Kronenburg HM, Larsen PR: Williams Textbook of Endocrinology. 9th ed. Saunders Company; 1998

5. Melmed S, Polonsky KS, Larsen PR, Kronenberg H: Williams Textbook of Endocrinology. 12th ed. Saunders Company; 2011:348-414

6. Heil W, Ehrhardt V: Reference intervals for adults and children. 9th ed. Roche Diagnostics; 2009 Jul;V9.1

7. Freedman DB, Halsall D, Marshall WJ, Ellervik C: Thyroid disorders. In: Rifai N, Horvath AR, Wittwer CT: eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018:1572-1616

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

The cobas e immunoassay thyrotropin (TSH, formerly thyroid-stimulating hormone) method employs monoclonal antibodies specifically directed against human TSH. A biotinylated monoclonal TSH-specific antibody and a monoclonal TSH-specific antibody labeled with a ruthenium complex react to form a sandwich complex. After the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Application of a voltage to the electrode then induces chemiluminescent emission, which is measured by a photomultiplier.(Package insert: Elecsys TSH. Roche Diagnostics; 12/2018)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 2 days

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

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US 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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

84443

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
STSH TSH, Sensitive, S 11579-0
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
STSH TSH, Sensitive, S 11579-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Create a PDF

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports