Test Catalog

Test Id : T4FT4

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T4 (Thyroxine), Total and Free, Serum

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Overview

Test Catalog

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

Assessing thyroid function when thyroid function disorders are suspected

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test Id Reporting Name Available Separately Always Performed
T4F T4 (Thyroxine), Free, S No Yes
T4CC T4 (Thyroxine), Total Only, S No Yes

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

Electrochemiluminescence 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

T4 (Thyroxine), Total and Free

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

T4, Serum

T4, Free, Serum

Specimen Type
Describes the specimen type validated for testing

Serum

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

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.

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

0.625 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 Reject

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 72 hours

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

Assessing thyroid function when thyroid function disorders are suspected

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

Total Thyroxine:

Thyroxine (T4) is synthesized in the thyroid gland. T4 is metabolized to triiodothyronine (T3) peripherally by deiodination. T4 is considered a reservoir or prohormone for T3, the biologically most active thyroid hormone. About 0.05% of circulating T4 is in the free, ie, unbound, portion. The remainder is bound to thyroxine-binding globulin), prealbumin, and albumin.

 

The hypothalamus secretes thyrotropin-releasing hormone, which stimulates the pituitary to release thyrotropin, formerly thyroid-stimulating hormone (TSH). TSH stimulates the thyroid to secrete T4. T4 is partially converted peripherally to T3. High amounts of T4 and T3 (mostly from peripheral conversion of T4) cause hyperthyroidism.

 

T4 and T3 cause positive feedback to the pituitary and hypothalamus with resultant suppression or stimulation of the thyroid gland as follows: decrease of TSH if T3 or T4 is high (hyperthyroidism) and increase of TSH if T3 or T4 is low (hypothyroidism).

 

Measurement of total T4 gives a reliable reflection of clinical thyroid status in the absence of protein binding abnormalities. However, changes in binding proteins can occur that affect the level of total T4 but leave the level of unbound hormone unchanged.

 

Free Thyroxine:

Free thyroxine comprises a small fraction of total thyroxine. The free T4 (FT4) is available to the tissues and is, therefore, the metabolically active fraction.

 

Elevations in FT4 cause hyperthyroidism, while decreases cause hypothyroidism.

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.

T4 (THYROXINE), TOTAL ONLY

0-5 days: 5.0-18.5 mcg/dL

6 days-2 months: 5.4-17.0 mcg/dL

3 -11 months: 5.7-16.0 mcg/dL

1 -5 years: 6.0-14.7 mcg/dL

6 -10 years: 6.0-13.8 mcg/dL

11 -19 years: 5.9-13.2 mcg/dL

 > or =20 years: 4.5-11.7 mcg/dL

 

 

T4 (THYROXINE), FREE

0-5 days: 0.9-2.5 ng/dL

6 days-2 months: 0.9-2.2 ng/dL

3-11 months: 0.9-2.0 ng/dL

1-5 years: 1.0-1.8 ng/dL

6-10 years: 1.0-1.7 ng/dL

11-19 years: 1.0-1.6 ng/dL

 > or =20 years: 0.9-1.7 ng/dL

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

In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays. The presence of antibodies to streptavidin or ruthenium also rarely occur and may interfere with this assay. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation.

 

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)

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

1. Peyro Saint Paul L, 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

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 Sept;2(4):247-256. doi: 10.4155/ipk-2017-0013

3. Melmed S, Polonsky KS, Larsen PR, et al: Williams Textbook of Endocrinology. 12th ed. Elsevier Saunders; 2011:348-414

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

Total Thyroxine:

Testing is performed on a Roche cobas instrument. The Roche thyroxine (T4) assay is a competitive assay using electrochemiluminescence detection. Bound T4 is released from binding proteins by 8-anilino-1-naphthalene sulfonic acid. Patient specimen is incubated with sheep polyclonal anti-T4 antibody labeled with ruthenium. Streptavidin-coated microparticles and biotinylated T4 are added for a second incubation during which the still free binding sites of the labeled antibody become occupied. The resulting immunocomplex becomes bound to the solid phase by 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. Unbound substances are then removed, and application of a voltage to the electrode induces the electrochemiluminescent emission. This signal is measured against a calibration curve to determine patient results.(Package insert: Elecsys T4. Roche Diagnostics; V2 English, 10/2022)

 

Free Thyroxine:

Testing is performed on a Roche cobas immunoassay analyzer. In the Roche free T4 assay, the determination of free T4 is made with the aid of a specific anti-T4 antibody labeled with a ruthenium complex. After addition of biotinylated T4 and streptavidin-coated microparticles, the still free binding sites of the labeled antibody become occupied, with formation of an antibody-hapten complex. The entire 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. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission, which is measured by a photomultiplier.(Package insert: Elecsys FT4II. Roche Diagnostics; V1, 01/2019)

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.

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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.

84436

84439

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
T4FT4 T4 (Thyroxine), Total and Free 90224-7
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.
T4F T4 (Thyroxine), Free, S 83122-2
T4CC T4 (Thyroxine), Total Only, S 83119-8

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 | PHP Pdf | CMS 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