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Test Code MISC2MAYOHE4 Human Epididymis Protein 4, Serum

Useful For

Aiding in monitoring patients with treated epithelial ovarian cancer for recurrence or progression

 

This test should not be used as a screening test for ovarian cancer.

Reporting Name

HE4, S

Specimen Type

Serum


Specimen Required


Patient Preparation: For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Specimen Minimum Volume

0.75 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 84 days
  Refrigerated  7 days

Reject Due To

Gross hemolysis Reject
Gross lipemia OK

Clinical Information

Human epididymis (HE) protein 4 belongs to the family of whey acidic four-disulfide core (WFDC) proteins. Currently, the biologic function of HE4 is unknown.

 

Human epididymis protein 4 has been shown to be overexpressed in 93% of serous, 100% of endometrioid, and 50% of clear cell ovarian carcinomas. In a study of 233 patients with a pelvic mass, including 67 with epithelial ovarian cancer, HE4 had a higher sensitivity for ovarian cancer detection than cancer antigen (CA) 125, 72.9% versus 43.3%, respectively, at a specificity of 95%. Researchers also found HE4 to be elevated in more than half of the ovarian cancer patients who did not have elevated CA 125 levels; therefore, the combination of markers provided slightly improved cancer diagnostic sensitivity for the detection of ovarian cancer.

 

The main established application of HE4 is in post-therapy monitoring of ovarian cancer patients, who had elevated pretreatment levels. In this setting, it complements CA 125 measurement and facilitates follow-up of patients with little or no CA 125 pretreatment elevations.

 

Certain histological types of ovarian cancer (mucinous or germ cell tumors) rarely express HE4, therefore the use of HE4 is not recommended for monitoring of patients with these types of ovarian cancer.

Reference Values

Females: ≤140 pmol/L

Males: Not applicable

Interpretation

Increase in human epididymis protein 4 (HE4) suggests recurrence or disease progression, while a decrease suggests therapeutic response. A change in serum HE4 concentration of greater than or equal to 20% is considered significant.

Method Description

The Roche Elecsys HE4 (human epididymal protein 4) assay is a sandwich electrochemiluminescence immunoassay that employs a biotinylated monoclonal HE4-specific antibody and a monoclonal HE4-specific antibody labeled with ruthenium complex. HE4 in the specimen reacts with both the biotinylated monoclonal HE4-specific antibody (mouse) and the monoclonal HE4-specific antibody (mouse) labeled with ruthenium, forming a sandwich complex. Streptavidin-coated microparticles are added and the mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed. Application of voltage to the electrode induces the chemiluminescent emission, which is then measured against a calibration curve to determine the amount of HE4 in the patient specimen.(Package insert: Roche Elecsys HE4. Roche Diagnostics; V 3.0, 06/2024)

Day(s) Performed

Monday through Saturday

Report Available

1 to 3 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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

86305

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HE4 HE4, S 55180-4

 

Result ID Test Result Name Result LOINC Value
HE4 HE4, S 55180-4

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Secondary ID

62137

Forms

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