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Test ID: INHB
Inhibin B, Serum

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

88722

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

As an aid in the diagnosis of granulosa cell tumors and mucinous epithelial ovarian tumors

 

Monitoring of patients with granulosa cell tumors and epithelial mucinous-type tumors of the ovary known to overexpress inhibin B

 

As an adjunct to follicle-stimulating hormone testing during infertility evaluation

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

Enzyme-Linked Immunosorbent Assay (ELISA)

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

Inhibin B, S

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: 0.4 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.

0.2 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 90 days

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

Inhibins are heterodimeric protein hormones secreted by granulosa cells of the ovary in females and Sertoli cells of the testis in males. Inhibins selectively suppress the secretion of pituitary follicle-stimulating hormone (FSH) and also have local paracrine actions in the gonads. The inhibins consist of a dimer of 2 homologous subunits, an alpha subunit and either a beta A or beta B subunit, to form inhibin A and inhibin B, respectively.

 

In females, inhibin A is primarily produced by the dominant follicle and corpus luteum, whereas inhibin B is primarily produced by small developing follicles. Serum inhibin A and B levels fluctuate during the menstrual cycle. Inhibin A is low in the early follicular phase and rises at ovulation to maximum levels in the midluteal phase. In contrast, inhibin B levels increase early in the follicular phase to reach a peak coincident with the onset of the midfollicular phase decline in FSH levels. Inhibin B levels decrease in the late follicular phase. There is a short-lived peak of the hormone 2 days after the midcycle luteinizing hormone (LH) peak. Inhibin B levels remain low during the luteal phase of the cycle. The timing of the inhibin B rise suggests that it plays a role in regulation of folliculogenesis via a negative feedback on the production of FSH. At menopause, with the depletion of ovarian follicles, serum inhibin A and B decrease to very low or undetectable levels.  

 

Ovarian cancer is classified into 3 types: epithelial (80%), germ cell tumors (10%-15%), and stromal sex-cord tumors (5%-10%). Epithelial ovarian tumors are further subdivided into serous (70%), mucinous (10%-15%), and endometrioid (10%-15%) types. Granulosa cell tumors represent the majority of the stromal sex-cord tumors.

 

Elevations of serum inhibin A and/or B are detected in some patients with granulosa cell tumors. Inhibin B elevations have been reported in 89% to 100% of patients with granulosa cell tumors. In those patients, inhibin B levels tend to be elevated about 60-fold over the reference range value. The frequency of elevated levels varies amongst studies, likely due to the different specificities of the antibodies used in the immunoassays. Inhibin B also appears to be a suitable serum marker for epithelial tumors of the mucinous type with about 55% to 60% having elevated inhibin B levels. In contrast, inhibin is not a very good marker in nonmucinous epithelial tumors. At best, total inhibin is elevated in 15% to 35% of nonmucinous epithelial ovarian cancer cases.

 

Inhibin seems to be complementary to cancer antigen 125 (CA 125) as an ovarian cancer marker. CA 125 is not as good of a tumor marker for mucinous and granulosa ovarian cell tumors. Inhibin shows a better performance in those 2 types of ovarian cancer.  

 

The majority of the studies for inhibin A and B as an ovarian cancer marker have been limited to postmenopausal women where the levels of inhibin are normally very low. Inhibin levels vary in relation to the menstrual cycle and, therefore, are difficult to interpret in premenopausal women.

 

Inhibin B has also been used as a marker of ovarian reserve. Every female is born with a specific number of follicles containing oocytes, a number that steadily and naturally declines with age. The number of follicles remaining in the ovary at any time is called the ovarian reserve. As ovarian reserve diminishes, it is increasingly more difficult for the hormones used for in vitro fertilization (IVF) to stimulate follicle development and, thus, the likelihood of successful oocyte retrieval, fertilization, and embryo transfer decreases, all leading to a lower chance of conceiving. As part of an infertility evaluation, attempts are made to estimate a woman’s ovarian reserve. Tests to assess ovarian reserve include: day 3 FSH, day 3 inhibin B, and antimullerian hormone levels. The amount of inhibin B measured in serum during the early follicular phase of the menstrual cycle (day 3) directly reflects the number of follicles in the ovary. Therefore, the higher the inhibin B, the more ovarian follicles present. The level of inhibin B that predicts a poor response to IVF treatment has not been established with this assay.

 

In males, inhibin B levels are higher in men with apparently normal fertility than in those with infertility and abnormal spermatogenesis. Serum inhibin B, when used in combination with FSH, is a more sensitive marker of spermatogenesis than FSH alone. However, the optimal level of inhibin B to assess male infertility has not been established.

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                   

0-23 months: <430 pg/mL

2-4 years: <269 pg/mL

5-7 years: <184 pg/mL

8-10 years: <214 pg/mL

11-13 years: <276 pg/mL

14-17 years: <273 pg/mL

Adults: <399 pg/mL

Females

0-23 months: <111 pg/mL

2-4 years: <44 pg/mL

5-7 years: <27 pg/mL

8-10 years: <67 pg/mL

11-13 years: <120 pg/mL

14-17 years: <136 pg/mL

Premenopausal               

Follicular: <139 pg/mL

Luteal: <92 pg/mL

Postmenopausal: <10 pg/mL

Interpretation Provides information to assist in interpretation of the test results

Inhibin B levels are elevated in approximately 89% to 100% of patients with granulosa cell tumors and in approximately 55% to 60% of patients with epithelial ovarian tumors. A normal inhibin B level does not rule out a mucinous or granulosa ovarian cell tumor. Testing for inhibin A in these cases might be informative. Consider ordering INHAB/86336 Inhibin A and B, Tumor Marker, Serum.

 

For monitoring of patients with known ovarian cancer, inhibin B levels decrease to very low or undetectable levels shortly after surgery. Elevations of inhibin B after treatment are suggestive of residual, recurrent, or progressive disease. In patients with recurrent disease, inhibin B elevation seems to be present earlier than clinical symptoms. Patients in remission show normal levels of inhibin B.  

 

For infertility evaluation, an inhibin B level in the postmenopausal range is suggestive of a diminished or depleted ovarian reserve.

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

Inhibin values fluctuate during the menstrual cycle. Inhibin levels in premenopausal women should be interpreted with caution.

 

Do not interpret serum inhibin levels as absolute evidence of the presence or the absence of malignant disease. Use results in conjunction with information from the clinical evaluation of the patient and other diagnostic procedures.

 

Tumor markers are not specific for malignancy and values may vary by testing methodology. The same method should be used to serially monitor patients.

 

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. Mom CH, Engelen MJ, Willemse PH, et al: Granulosa cell tumors of the ovary: the clinical value of serum inhibin A and B levels in a large single center cohort. Gynecol Oncol 2007 May;105(2):365-372

2. Robertson DM, Pruysers E, Jobling T: Inhibin as a diagnostic marker for ovarian cancer. Cancer Lett 2007; 249:14-17

3. Jamieson S, Fuller PJ: Management of granulosa cell tumour of the ovary. Curr Opin Oncol 2008;20(5):560-564

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

Inhibin B Gen II ELISA (enzyme-linked immunosorbent assay) is an enzymatically amplified 3-step "sandwich'' assay. Sample is incubated in wells that have been coated with antiactivin B antibody. After incubation and washing, the wells are incubated with biotinylated anti-inhibin detection antibody. After a second incubation and washing step, the wells are incubated with streptavidin labeled with the enzyme horseradish peroxidase. Antibody-analyte complex is detected by dual wavelength absorbance measurement after addition of the tetramethylbenzidine substrate. The absorbance measured is directly proportional to the concentration of inhibin B in the samples. (Package insert: Inhibin B Gen II ELISA kit, Beckman Coulter, Inc. Brea, CA)

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.

Tuesday, Thursday; 9:00 a.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.

1 day/same day

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 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 uses a reagent or kit labeled by the manufacturer as Research Use Only. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

83520

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
88722Inhibin B, S56940-0