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Test ID: INHA
Inhibin A, Tumor Marker, Serum

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

81049

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

An aid in the diagnosis of patients with granulosa cell tumors of the ovary when used in combination with inhibin B

 

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

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

Sequential 2-Step Immunoenzymatic Assay

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

Inhibin A, Tumor Marker, 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: 0.6 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.

0.5 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 the female and Sertoli cells of the testis in the male. They 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 predominantly produced by small developing follicles. Serum inhibin A and B levels fluctuate during the menstrual cycle. 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, stromal sex cord, and germ cell tumors. Epithelial ovarian tumors account for 90% of cases and 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, which account for 2% to 5% of all ovarian tumors.

 

Elevations of serum inhibin A and/or B are detected in some patients with granulosa cell tumors. Inhibin A elevations have been reported in approximately 70% of granulosa cell tumors. In these patients, inhibin A levels tend to show a 6-fold to 7-fold increase 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 A also appears to be suitable markers for epithelial tumors of the mucinous type with about 20% of cases having elevated inhibin A 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 a 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 for both proteins are normally very low. Inhibin A has limited utility as an ovarian cancer marker in premenopausal women, where circulating levels are higher and fluctuate throughout the menstrual cycle and, therefore, are difficult to interpret.

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: <2.0 pg/mL

Females

<11 years: <4.7 pg/mL

11-17 years: <97.5 pg/mL

Premenopausal: <97.5 pg/mL

Postmenopausal: <2.1 pg/mL

Interpretation Provides information to assist in interpretation of the test results

Inhibin A levels are elevated in approximately 70% of patients with granulosa cell tumors and in approximately 20% of patients with epithelial ovarian tumors. A normal inhibin A level does not rule-out a mucinous or granulosa ovarian cell tumor. Testing for inhibin B in these cases might be informative as a higher proportion of mucinous or granulosa ovarian cell tumors will have an elevated inhibin B level. Consider ordering INHAB/86336 ‘Inhibin A and B, Tumor Marker, Serum.’

 

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

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

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.

 

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

 

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.

 

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

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

The instrument used is a Beckman Coulter Unicel DXI 800. The Access Inhibin A assay is a sequential 2-step immunoenzymatic (“sandwich’’) assay. Sample is added to a reaction vessel and incubated with paramagnetic particles coupled with anti-inhibin A monoclonal antibody. Excess sample and reagents are removed and anti-inhibin A monoclonal antibody-alkaline phosphatase conjugate is then added to a reaction mixture. Antibody-analyte complex is detected by addition of the chemiluminescent substrate Lumi-Phos* 530. The light production is directly proportional to the concentration of inhibin A in the sample. (Package insert: 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.

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

14 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 has been modified from the manufacturer’s instructions. Its performance characteristics were determined 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

86336

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
INHAInhibin A, Tumor Marker, S23883-2