Test Catalog

Test Id : FSH

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Follicle-Stimulating Hormone (FSH), Serum

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Overview

Test Catalog

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

An adjunct in the evaluation of menstrual irregularities

 

Evaluating patients with suspected hypogonadism

 

Predicting ovulation

 

Evaluating infertility

 

Diagnosing pituitary disorders

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

Follicle-Stim Hormone (FSH), S

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

Follicle Stimulating Hormone (FSH), Serum

FSH (Follicle-Stimulating Hormone)

FSH, Serum

Pituitary Gonadotropins

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: 0.6 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial within 2 hours of collection.

Forms

If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.

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 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 180 days
Ambient 24 hours

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

An adjunct in the evaluation of menstrual irregularities

 

Evaluating patients with suspected hypogonadism

 

Predicting ovulation

 

Evaluating infertility

 

Diagnosing pituitary disorders

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

Luteinizing hormone (LH) is a glycoprotein hormone consisting of 2 noncovalently bound subunits (alpha and beta). Gonadotropin-releasing hormone from the hypothalamus controls the secretion of the gonadotropins, follicle-stimulating hormone (FSH) and LH, from the anterior pituitary.

 

The menstrual cycle is divided by a midcycle surge of both FSH and LH into a follicular phase and a luteal phase.

 

FSH appears to control gametogenesis in both male and female individuals.

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 months: < or =3.3 IU/L

12 months-5 years: < or =1.9 IU/L

>5 years-10 years: < or =2.3 IU/L

>10 years-15 years: 0.6-6.9 IU/L

>15 years-18 years: 0.7-9.6 IU/L

>18 years: 1.2-15.8 IU/L

 

TANNER STAGES*

Stage l: <1.5 IU/L

Stage ll: <3.0 IU/L

Stage lll: 0.4-6.2 IU/L

Stage lV: 0.6-5.1 IU/L

Stage V: 0.8-7.2 IU/L

*Puberty onset occurs for boys at a median age of 11.5 (+/- 2) years. For boys, there is no proven relationship between puberty onset and body weight or ethnic origin. Progression through Tanner stages is variable. Tanner stage V (adult) should be reached by age 18.

 

Females

<12 months: 1.2-12.5 IU/L

12 months-10 years: 0.5-6.0 IU/L

>10 years-15 years: 0.9-8.9 IU/L

>15 years-18 years: 0.7-9.6 IU/L

Premenopausal:

Follicular: 2.9-14.6 IU/L

Midcycle: 4.7-23.2 IU/L

Luteal: 1.4-8.9 IU/L

Postmenopausal: 16.0-157.0 IU/L

 

TANNER STAGES*

Stage l: 0.6-4.1 IU/L

Stage ll: 0.3-5.8 IU/L

Stage lll: 0.1-7.2 IU/L

Stage lV: 0.3-7.0 IU/L

Stage V: 0.4-8.6 IU/L

*Puberty onset (transition from Tanner stage I to Tanner stage II) occurs for girls at a median age of 10.5 (+/- 2) years. There is evidence that it may occur up to 1 year earlier in obese girls and in African American girls. Progression through Tanner stages is variable. Tanner stage V (adult) should be reached by age 18.

Interpretation
Provides information to assist in interpretation of the test results

In both male and female patients, primary hypogonadism results in an elevation of basal follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels.

 

FSH and LH are generally elevated in:

-Primary gonadal failure

-Complete testicular feminization syndrome

-Precocious puberty (either idiopathic or secondary to a central nervous system lesion)

-Menopause (postmenopausal FSH levels are generally >40 IU/L)

-Primary ovarian hypofunction in female patients

-Primary hypogonadism in male patients

 

Normal or decreased FSH in:

-Polycystic ovary disease in female patients

 

FSH and LH are both decreased in failure of the pituitary or hypothalamus.

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)

 

No clinically significant cross-reactivity has been demonstrated with thyrotropin (formerly thyroid-stimulating hormone), luteinizing hormone, human chorionic gonadotropin, prolactin, or growth hormone.

 

Some patients who have been exposed to animal antigens, either in the environment or as part of treatment or imaging procedures, may have circulating anti-animal antibodies present. These antibodies may interfere with the assay reagents to produce unreliable results.

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. Int J Pharmacokinet. 2017 Sep;2(4):247-256. doi: 10.4155/ipk-2017-0013

3. Holmes DT, Bertholf RL, Winter WE: Pituitary function and pathophysiology. In: Rifai N, Chiu RWK, Young I, Burnham CAD, eds. Tietz Textbook of Laboratory Medicine. 7th ed. Elsevier; 2023:767-804

4. Nerenz RD, Boh B: Reproductive endocrinology and related disorders. In: Rifai N, Chiu RWK, Young I, Burnham CAD, eds. Tietz Textbook of Laboratory Medicine. 7th ed. Elsevier; 2023:846-884

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

In the Roche follicle-stimulating hormone (FSH) assay, the determination of the FSH is made with the aid of a biotinylated monoclonal FSH-specific antibody and a monoclonal FSH-specific antibody labeled with a ruthenium complex to form a sandwich complex. After 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. 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 FSH. Roche Diagnostics; 09/2021)

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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  • 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.

83001

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
FSH Follicle-Stim Hormone (FSH), S 15067-2
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.
FSH Follicle-Stim Hormone (FSH), S 15067-2

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