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Test Code Epic LAB4115 Human Epididymis Protein 4, Serum

Additional Codes

Sunquest code HE4M

Mayo test code HE4

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

Reference Values

Females: ≤140 pmol/L

Males: Not applicable

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.