Test ID: FSH
Follicle-Stimulating Hormone (FSH), Serum
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
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
Immunoenzymatic Assay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
FSH (Follicle-Stimulating Hormone)
FSH, Serum
Pituitary gonadotropins
Specimen Type Describes the specimen type needed for testing
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: Serum gel
Acceptable: Red top
Specimen Volume: 0.6 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.
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 Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 7 days |
| Frozen | 7 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Gonadotropin-releasing hormone from the hypothalamus controls the secretion of the gonadotropins, follicle-stimulating hormone (FSH) and luteinizing hormone (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 males and females.
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
1-7 days: < or =3.0 IU/L
8-14 days: < or =1.4 IU/L
15 days-3 years: < or =2.5 IU/L
4-6 years: < or =6.7 IU/L
7-8 years: < or =4.1 IU/L
9-10 years: < or =4.5 IU/L
11 years: 0.4-8.9 IU/L
12 years: 0.5-10.5 IU/L
13 years: 0.7-10.8 IU/L
14 years: 0.5-10.5 IU/L
15 years: 0.4-18.5 IU/L
16 years: < or =9.7 IU/L
17 years: 2.2-12.3 IU/L
> or =18 years: 1.0-18.0 IU/L
TANNER STAGES*
Stage l: < or =3.7 IU/L
Stage ll: < or =12.2 IU/L
Stage lll: < or =17.4 IU/L
Stage lV: 0.3-8.2 IU/L
Stage V: 1.1-12.9 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
1-7 days: < or =3.4 IU/L
8-14 days: < or =1.0 IU/L
15 days-6 years: < or =3.3 IU/L
7-8 years: < or =11.1 IU/L
9-10 years: 0.4-6.9 IU/L
11 years: 0.4-9.0 IU/L
12 years: 1.0-17.2 IU/L
13 years: 1.8-9.9 IU/L
14-16 years: 0.9-12.4 IU/L
17 years: 1.2-9.6 IU/L
> or =18 years:
Premenopausal
Follicular: 3.9-8.8 IU/L
Midcycle: 4.5-22.5 IU/L
Luteal: 1.8-5.1 IU/L
Postmenopausal: 16.7-113.6 IU/L
TANNER STAGES*
Stage l: 0.4-6.7 IU/L
Stage ll: 0.5-8.7 IU/L
Stage lll: 1.2-11.4 IU/L
Stage lV: 0.7-12.8 IU/L
Stage V: 1.0-11.6 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.
Pediatric ranges derived for DXI method from analytic comparison to reference method in: Elmlinger MW, Kuhnel W, Ranke MB: Reference ranges for serum concentrations of lutropin (LH), follitropin (FSH), estradiol (E2), prolactin, progesterone, sex hormone-binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), cortisol and ferritin in neonates, children and young adults. Clin Chem Lab Med 2002;40(11):1151-1160
Interpretation Provides information to assist in interpretation of the test results
In both males and females, 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 females
-Primary hypogonadism in males
Normal or decreased FSH in:
-Polycystic ovary disease in females
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
No clinically significant cross-reactivity has been demonstrated with 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 antianimal antibodies present. These antibodies may interfere with the assay reagents to produce unreliable results.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. The gonads. In Clinical Chemistry: Theory, Analysis, Correlation, 4th Edition. Edited by LA Kaplan, AJ Pesce, SC Kazmierczak. St. Louis, MO. Mosby, 2003, p. 1179
2. Dumesic DA: Hyperandrogenic anovulation: a new view of polycystic ovary syndrome. Postgrad Ob Gyn 1995;15:1-5
Method Description Describes how the test is performed and provides a method-specific reference
The instrument used is Beckman Coulter Unicel DXI 800. The Access human follicle-stimulating hormone (hFSH) assay is a sequential 2-step immunoenzymatic sandwich assay. A sample is added to a reaction vessel with paramagnetic particles coated with goat antimouse:mouse anti-hFSH complexes and TRIS buffered saline with protein. The hFSH binds to the immobilized mouse anti-hFSH on the solid phase. Materials bound to the solid phase are held in a magnetic field, while unbound materials are washed away. Alkaline phosphatase conjugated goat anti-hFSH is then added and binds to the previously bound hFSH on the particles. A second separation and wash step removes unbound conjugate. The chemiluminescent substrate Lumi-Phos 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of hFSH in the sample. The amount of analyte in the sample is determined from a stored, multipoint calibration curve. (Instruction manual: Beckman Coulter, Inc., Fullerton, CA, 2010)
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.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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.
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.
83001
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 ID | Reporting Name | LOINC Code |
|---|---|---|
| FSH | FSH, S | 15067-2 |
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