Test Catalog

Test Id : TBGI

Thyroxine-Binding Globulin (TBG), Serum

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

Cases in which total thyroid hormone levels do not correlate with the thyrometabolic status, most commonly with pregnancy or the use of contraceptive steroids

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

Solid-Phase Chemiluminescent Assay

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

Thyroxine Binding Globulin, S

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

TBG (Thyroxine-Binding Globulin)

TBG by Immunoassay

Thyroid Binding Globulin

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

Patient Preparation: For 12 hours before specimen collection, do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 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

0.35 mL

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

Gross hemolysis Reject
Gross lipemia 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

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

Cases in which total thyroid hormone levels do not correlate with the thyrometabolic status, most commonly with pregnancy or the use of contraceptive steroids

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

Thyroxine binding globulin (TBG) is the high-affinity serum binding protein for thyroxine and triiodothyronine. Normally, the thyroid adjusts to changing concentrations of TBG by producing more, or less, thyroid hormone to maintain a constant level of metabolically important free hormone.

 

Elevated TBG levels are associated with influences such as pregnancy, genetic predisposition, oral contraceptives, and estrogen therapy. TBG levels can decrease with androgenic or anabolic steroids, large doses of glucocorticoids, hypoproteinemic states, liver disease, nephrotic syndrome, and congenital TBG variants.

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.

Males: 12-26 mcg/mL

Females: 11-27 mcg/mL

 

For International System of Units (SI) conversion for Reference Values, see www.mayocliniclabs.com/order-tests/si-unit-conversion.html

Interpretation
Provides information to assist in interpretation of the test results

A change in thyroxine-binding globulin (TBG) concentration may be of hereditary, pathophysiologic, or pharmacologic origin.

 

The TBG concentration indicates whether an abnormally high or low total thyroid hormone concentration is offset by a parallel increase or decrease in TBG concentration.

 

In TBG deficiency, one may find euthyroid patients with extremely low total thyroxine (T4) values. Conversely, patients with high TBG levels may be clinically euthyroid with high serum total T4 values.

 

Twenty-four specimens obtained during various stages of pregnancy yielded results ranging from 27 to 66 mcg/mL with a median of 43 mcg/mL. The literature suggests 47 to 59 mcg/mL as the range of TBG values expected during the third trimester of pregnancy.

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

Females using estrogen-based contraception may exceed the reference range.

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

1. Burtis CA, Ashwood ER, Bruns DE eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 4th ed. Elsevier; 2006:2053-2095

2. Wenzel KW: Pharmacological interference with in vitro tests of thyroid function. Metabolism. 1981;30:717-732

3. Mimoto MS, Refetoff S. Clinical recognition and evaluation of patients with inherited serum thyroid hormone-binding protein mutations. J Endocrinol Invest. 2020;43(1):31-41. doi: 10.1007/s40618-019-01084-9

4. Pappa T, Ferrara AM, Refetoff S. Inherited defects of thyroxine-binding proteins. Best Pract Res Clin Endocrinol Metab. 2015;29(5):735-747

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

The IMMULITE 2000 TBG (thyroxine-binding globulin) is a solid-phase chemiluminescent immunoassay. The solid phase, a polystyrene bead, is coated with a monoclonal antibody specific for TBG. The patient sample and alkaline phosphate-conjugated TBG are added and incubated. During this time, TBG in the sample competes with the enzyme-labeled TBG for a limited number of antibody binding sites on the bead. Unbound enzyme conjugate is removed by washing and the chemiluminescent substrate is added. The substrate, a phosphate ester of adamantyl dixetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of the intermediate results in the sustained emission of light. The photon output is inversely proportional to the concentration of the TBG in the sample.(Package insert: IMMULITE 2000 TBG PIL2KTB-16. Siemens Medical Solutions; 03/15/2018)

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, Wednesday, Friday

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.

1 to 3 days

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

2 weeks

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 account representative. 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.

84442

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
TBGI Thyroxine Binding Globulin, S 3021-3
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.
TBGI Thyroxine Binding Globulin, S 3021-3

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