Test Catalog

Test Id : APGH

Alpha-Subunit Pituitary Tumor Marker, Serum

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

Adjunct in the diagnosis of pituitary tumors

 

As part of the follow-up of treated pituitary tumor patients

 

Differential diagnosis of thyrotropin-secreting pituitary tumor versus thyroid hormone resistance

 

Differential diagnosis of constitutional delay of puberty versus hypogonadotrophic hypogonadism

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

Immunochemiluminescent 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

AlphaSubunit Pituitary Tumor Marker

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

Alpha Glycoprotein Subunit

Alpha Subunit, HCG

Alpha-HCG (Human Chorionic Gonadotropin)

Alpha-PGH (Pituitary Glycoprotein Hormone)

Alpha-Subunit of Pituitary Glycoprotein Hormones (Alpha-PGH), Serum

Chorionic Gonadotropins, Alpha-Subunit

Glycoprotein Subunit

HCG, Alpha Subunit

Hormone, Alpha-Subunit

PGH (Pituitary Glycoprotein Hormone)

Pituitary Glycoprotein Alpha Subunit

Pituitary Gonadotropins, Alpha-Subunit

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

This test should not be ordered on pregnant patients.

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: 1 mL

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

0.35 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 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 Frozen (preferred) 90 days
Refrigerated 7 days

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

Adjunct in the diagnosis of pituitary tumors

 

As part of the follow-up of treated pituitary tumor patients

 

Differential diagnosis of thyrotropin-secreting pituitary tumor versus thyroid hormone resistance

 

Differential diagnosis of constitutional delay of puberty versus hypogonadotrophic hypogonadism

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

The 3 human pituitary glycoprotein hormones: luteinizing hormone (LH), follicle-stimulating hormone (FSH), thyrotropin (TSH), and the placenta-derived chorionic gonadotropin (hCG), are closely related tropic hormones. They signal through G-protein-coupled receptors, regulating the hormonal activity of their respective endocrine target tissues. Each is composed of an alpha- and a beta-subunit, coupled by strong noncovalent bonds. The alpha-subunits of all 4 hormones are essentially identical (92 amino acids; molecular weight [MW] of the "naked" protein:10,205 Da), being transcribed from the same gene and showing only variability in glycosylation (MW of the glycosylated proteins:13,000-18,000 Da). The alpha-subunits are essential for receptor transactivation. By contrast, all the different beta-subunits are transcribed from separate genes, show less homology, and convey the receptor specificity of the dimeric hormones.

 

Under physiological conditions, alpha- and beta-chain synthesis and secretions are tightly coupled, and only small amounts of monomeric subunits are secreted. However, under certain conditions, coordinated production of intact glycoprotein hormones may be disturbed and disproportionate quantities of free alpha-subunits are secreted. In particular, some pituitary adenomas may overproduce alpha subunits. Although most commonly associated with gonadotroph- or thyrotroph-derived tumors, alpha-subunit secretion has also been observed in corticotroph, lactotroph, and somatotroph pituitary adenomas. Overall, depending on cell type and tumor size, 5% to 30% of pituitary adenomas will produce sufficient free alpha-subunits to result in elevated serum levels, which usually fall with successful treatment. Stimulation testing with hypothalamic releasing factors (eg, gonadotropin releasing hormone: GnRH or thyrotropin-releasing hormone: TRH) may result in further elevations, disproportionate to those seen in individuals without tumors.

 

Measurement of free alpha-subunit after GnRH-stimulation testing can also be useful in the differential diagnosis of constitutional delay of puberty (CDP) versus hypogonadotrophic hypogonadism (HH). CDP is a benign, often familial, condition in which puberty onset is significantly delayed, but eventually occurs and then proceeds normally. By contrast, HH represents a disease state characterized by lack of gonadotropin production. Its causes are varied, including hypothalamic and pituitary inflammatory or neoplastic disorders, a range of specific genetic abnormalities, as well as unknown causes. In children, HH results in complete failure to enter puberty without medical intervention. In children with CDP, in normal pubertal children, in normal adults and, to a lesser degree, in normal prepubertal children, GnRH administration results in increased serum LH, FSH, and alpha-subunit levels. This response is greatly attenuated in patients with HH, particularly with regard to the post-GnRH rise in alpha-subunit concentrations.

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.

PEDIATRIC

< or =5 days: < or =50 ng/mL

6 days-12 weeks: < or =10 ng/mL

3 months-17 years: < or =1.2 ng/mL

Tanner II-IV*: < or =1.2 ng/mL

 

ADULTS

Males: < or =0.5 ng/mL

Premenopausal females: < or =1.2 ng/mL

Postmenopausal females: < or =1.8 ng/mL

 

Pediatric and adult reference values based on Mayo studies.

 

*Puberty onset (transition from Tanner stage I to Tanner stage II) occurs for boys at a median age of 11.5 (+/-2) years and 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. 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.

Interpretation
Provides information to assist in interpretation of the test results

In the case of pituitary adenomas that do not produce significant amounts of intact tropic hormones, diagnostic differentiation between sellar- and tumors of non-pituitary origin (eg, meningiomas or craniopharyngiomas) can be difficult. In addition, if such nonsecreting adenomas are very small, they can be difficult to distinguish from physiological pituitary enlargements.

 

In a proportion of these cases, free alpha-subunit may be elevated, aiding in diagnosis. Overall, 5% to 30% of pituitary adenomas produce measurable elevation in serum free alpha-subunit concentrations. There is also evidence that an exuberant free alpha-subunit response to thyrotropin-releasing hormone (TRH) administration may occur in some pituitary adenoma patients that do not have elevated baseline free alpha-subunit levels. A more than 2-fold increase in free alpha-subunit serum concentrations at 30 to 60 minutes following intravenous administration of 500 mcg of TRH is generally considered abnormal, but some investigators consider any increase of serum free alpha-subunit that exceeds the reference range as abnormal. TRH testing is not performed in the laboratory but in specialized clinical testing units under the supervision of a physician.

 

In pituitary tumors patients with pre-treatment elevations of serum free alpha-subunit, successful treatment is associated with a reduction of serum free alpha-subunit levels. Failure to lower levels into the normal reference range may indicate incomplete cure, and secondary rises in serum free alpha-subunit levels can indicate tumor recurrence.

 

Small thyrotropin (TSH)-secreting pituitary tumors are difficult to distinguish from thyroid hormone resistance. Both types of patients may appear clinically euthyroid or mildly hyperthyroid and may have mild-to-modest elevations in peripheral thyroid hormone levels along with inappropriately (for the thyroid hormone level) detectable TSH, or mildly-to-modestly elevated TSH. Elevated serum free alpha-subunit levels in such patients suggest a TSH secreting tumor, but genetic variant screening of the thyroid hormone receptor gene may be necessary for a definitive diagnosis.

 

Constitutional delay of puberty (CDP) is a benign, often familial condition in which puberty onset is significantly delayed but eventually occurs and then proceeds normally. By contrast, hypogonadotrophic hypogonadism (HH) represents a disease state characterized by lack of gonadotropin production. Its causes are varied, ranging from idiopathic over specific genetic abnormalities to hypothalamic and pituitary inflammatory or neoplastic disorders. In children, it results in complete failure to enter puberty without medical intervention. CDP and HH can be extremely difficult to distinguish from each other. Intravenous administration of 100 mcg gonadotropin releasing hormone (GnRH) results in much more substantial rise in free alpha-subunit levels in CDP patients, compared with HH patients. A greater than 6-fold rise at 30 or 60 minutes post-injection is seen in more than 75% of patients with CDP, while a less than 2-fold rise appears diagnostic of HH. Increments between 2- and 6-fold are nondiagnostic.

 

GnRH testing is not performed in the laboratory but in specialized clinical testing units under the supervision of a physician.

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

False-positive elevations in serum free alpha-subunit levels may be seen in some women if blood specimens are drawn within 24 hours of ovulation.

 

Patients with end-stage renal failure may have serum free alpha-subunit concentrations of up to 6-times the upper limit of reference range.

 

Elevated alpha-subunit results on patients with elevated thyrotropin (TSH) should be interpreted with caution due to TSH cross-reactivity with the assay.

 

Assisted reproduction involving ovarian hyperstimulation or in vitro fertilization may be associated with the elevation in serum free alpha-subunit levels.

 

Pregnancy is associated with very substantial, physiological elevations in serum free alpha-subunit levels, paralleling chorionic gonadotropin (hCG) secretion. This test should not be ordered on pregnant patients.

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

1. Preissner CM, Klee GG, Scheithauer BW, Abboud CF: Free alpha subunit of the pituitary glycoprotein hormones. Measurement in serum and tissue of patients with pituitary tumors. Am J Clin Pathol. 1990 Oct;94(4):417-421

2. Samejima N, Yamada S, Takada K, et al: Serum alpha-subunit levels in patients with pituitary adenomas. Clin Endocrinol. 2001 Apr:54(4):479-484

3. Mainieri AS, Elnecave RH: Usefulness of the free alpha-subunit to diagnose hypogonadotropic hypogonadism. Clin Endocrionol. 2003 Sep;59(3):307-313

4. Socin HV, Chanson P, Delemer B, et al: The changing spectrum of TSH-secreting pituitary adenomas: diagnosis and management in 43 patients. Eur J Endocrinol. 2003 Apr;148(4):433-442

5. Solarski M, Rotondo F, Syro LV, Cusimano MD, Kovacs K: Alpha subunit in clinically non-functioning pituitary adenomas: An immunohistochemical study. Pathol Res Pract. 2017 Sep;213(9):1130-1133

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

Alpha-subunit pituitary glycoprotein hormone is measured using an immunochemiluminescent assay sandwich procedure. Standards, controls, and specimens are first incubated with monoclonal antibody-coated beads for 2 hours. After washing, a different monoclonal antibody labeled with acridinium ester is added and incubated for 1 hour. After washing, the beads (with attached labeled antibody) are counted in a luminometer. The resulting chemiluminescent light units are directly proportional to the amount of alpha-subunit pituitary glycoprotein hormone present in the sample.(Unpublished Mayo method)

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.

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.

2 to 8 days

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

3 months

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 Regional Manager. 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 was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

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.

82397

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
APGH AlphaSubunit Pituitary Tumor Marker 14170-5
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.
9003 AlphaSubunit Pituitary Tumor Marker 14170-5

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 | 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