Protocol - Thyroid Stimulating Hormone (hTSH) in Serum
Description
This protocol provides an overview of the thyroid-stimulating hormone immunoassay according to the local laboratory. Some examples include LabCorp test 004259 or Quest Diagnostics test 899. Often free thyroxine (free T4 or FT4) level is tested along with TSH (LabCorp test 224576 or Quest Diagnostics test 867; CPT 84439). Because there are many comparable assays and instruments for measuring TSH, the protocol also provides basic guidelines to aid comparability among different studies.
Specific Instructions
Participants should stop taking biotin (vitamin B7, vitamin B8, vitamin H, coenzyme R) at least 72 hours prior to sample collection.
The Sickle Cell Disease Curative Therapy Working Group also recommends collecting free T4 (Thyroxine). When used concurrently with Thyroid-stimulating Hormone, free T4 provides more information about the etiology of hypothyroidism.
Availability
Protocol
Specimen Requirements and Storage Instructions
The thyroid-stimulating hormone assay is performed on serum. 0.3 to 0.8 milliliters of serum should be collected in a red-top or gel-barrier tube. The sample is stable for 14 days at room temperature, refrigerated or frozen.
Summary of the Thyroid-Stimulating Hormone Assay
The sample is incubated with biotinylated and ruthenium labeled monoclonal TSH-specific antibodies to form a sandwich complex. Voltage is applied to the sample to induce a chemiluminescence which is measured by a photomultiplier. Results are measured against a calibration curve.
Thyroid-Stimulating Hormone Assay Reference Ranges
Age | Range (micro-International Units per milliliter – ulU/mL) |
0 to 6 d | 0.700−15.200 |
7 d to 3 m | 0.720−11.000 |
3 m 1 d to 12 m | 0.730−8.350 |
1 to 5 y | 0.700−5.970 |
6 to 10 y | 0.600−4.840 |
>10 y | 0.450−4.500 |
The Sickle Cell Disease Curative Therapies Working Group notes that there are a number of different assays and instruments that are appropriate to measure thyroid stimulating hormone. Once an assay is chosen for a particular study, the Working Group recommends that no changes in the protocol be made over the course of the study. To aid comparability, the Working Group recommends that the investigator record the name of the assay, the make and manufacturer of equipment used and the repeatability and coefficients of variation for the assay.
Personnel and Training Required
A phlebotomist is required to draw the blood sample.
Equipment Needs
Laboratory with the equipment needed to perform the thyroid stimulating hormone assay
Requirements
| Requirement Category | Required |
|---|---|
| Major equipment | No |
| Specialized training | No |
| Specialized requirements for biospecimen collection | No |
| Average time of greater than 15 minutes in an unaffected individual | No |
Mode of Administration
Bioassay
Lifestage
Infant, Toddler, Child, Adolescent, Adult
Participants
All ages
Selection Rationale
The TSH test is widely available, standardized methodology for collecting, processing, and storing blood, performing the prothrombin test, and reporting results.
Language
English
Standards
| Standard | Name | ID | Source |
|---|
Derived Variables
None
Process and Review
Not applicable.
Protocol Name from Source
Thyroid Stimulating Hormone (TSH), CPT 84443
Source
Labcorp. (n.d.). Thyroid-stimulating Hormone (TSH). Retrieved February 23, 2021, from https://www.labcorp.com/tests/004259/thyroid-stimulating-hormone-tsh
Quest Diagnostics. TSH. Retrieved July 16, 2021, from TSH | Test Detail | Quest Diagnostics
General References
ElAlfy, M. S., El-Sherif, N. H., Sakr, H. M., & El Ashkar, M. (2019). Thyroid hemodynamic alterations in Egyptian patients with sickle cell disease: Relation to disease severity, total body iron and thyroid function. Expert Review of Hematology, 12(8), 589–596.
Farmakis, D., Angastiniotis, M., & Eleftheriou, A. (2017). A short guide for the management of transfusion dependent thalassaemia (TDT) (TIF Publication No. 23). Thalassaemia International Federation.
Hagag, A. A., El-Asy, H. M., Badraia, I. M., Hablas, N. M., & El-Latif, A. (2019). Thyroid function in Egyptian children with sickle cell anemia in correlation with iron load. Endocrine, Metabolic & Immune Disorders Drug Targets, 19(1), 46–52.
Protocol ID
851101
Variables
Export Variables| Variable Name | Variable ID | Variable Description | dbGaP Mapping | |
|---|---|---|---|---|
| PX851101_Thyroid_Stimulating_Hormone_Serum_Collected_Amount | ||||
| PX851101010000 | Was 0.3 to 0.8 milliliters of serum more | N/A | ||
| PX851101_Thyroid_Stimulating_Hormone_Serum_Make_Manufacturer_Equipment | ||||
| PX851101050000 | Make and manufacturer of equipment | N/A | ||
| PX851101_Thyroid_Stimulating_Hormone_Serum_Repeatability_Coefficients_Variation | ||||
| PX851101060000 | What is the repeatability and coefficients more | N/A | ||
| PX851101_Thyroid_Stimulating_Hormone_Serum_Results_Calibration | ||||
| PX851101040000 | Were the results measured against a more | N/A | ||
| PX851101_Thyroid_Stimulating_Hormone_Serum_Sample_Incubated | ||||
| PX851101030000 | Was the sample incubated with biotinylated more | N/A | ||
| PX851101_Thyroid_Stimulating_Hormone_Serum_Sample_Stable_Refrigerated | ||||
| PX851101020000 | Was the sample is stable for 14 days at room more | N/A | ||
Measure Name
Thyroid Stimulating Hormone
Release Date
August 16, 2021
Definition
Thyroid stimulating hormone is produced by the pituitary gland and stimulates release of thyroxine from the thyroid.
Purpose
This measure is used to assess thyroid status, including screening for hyperthyroidism and hypothyroidism. Complications of iron overload in sickle cell disease contribute to iron-related morbidity and mortality. Chronic red blood cell transfusions in sickle cell disease can lead to iron accumulation in the endocrine system and disrupt the secretion of thyroid stimulating hormone.
Keywords
sickle cell, sickle cell disease, thyroid stimulating hormone, TSH, iron, iron overload, curative therapies, blood transfusion, free T4, endocrine system, National Health and Nutrition Examination Survey, NHANES
Measure Protocols
| Protocol ID | Protocol Name |
|---|---|
| 851101 | Thyroid Stimulating Hormone (hTSH) in Serum |
Publications
There are no publications listed for this protocol.