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Test ID: TBGI
Thyroxine-Binding Globulin (TBG), Serum

Secondary ID A test code used for billing and in test definitions created prior to November 2011

9263

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

Yes

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

Determination of thyroxine-binding globulin levels is particularly useful for 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

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

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 needed for testing

Serum

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 0.5 mL

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

0.35 mL

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

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross OK

Icterus

NA

Other

NA

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
SerumRefrigerated (preferred)7 days
 Frozen 30 days

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

Thyroxine binding globin (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

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 Provides recommendations for further in-depth reading of a clinical nature

1. Burtis CA, Ashwood ER, Bruns DE: In Tietz Textbook of Clinical Chemistry and Molecular Diagnostics 2006, pp 2053-2095

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

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

The IMMULITE 2000 TBG is a solid-phase chemiluminescent immunoassay. The solid-phase, a polystyrene bead, is coated with a monoclonal antibody specific for thyroxine-binding globulin (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, Los Angeles, CA 2008-07-29)

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

Monday through Friday; 5 a.m.-12 a.m., Saturday; 6 a.m.-6 p.m.

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

Same day/1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

3 days

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

14 days

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

Rochester

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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

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 Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

84442

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
TBGIThyroxine Binding Globulin, S3021-3