Ordering Recommendation

Use with CA 125 to monitor ovarian cancer, usually epithelial subtype, post therapy if pretreatment level was elevated. Not recommended for monitoring known mucinous or germ cell ovarian cancer. Not a stand-alone test for ovarian cancer screening or diagnosis.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum Separator Tube (SST). Also acceptable: Green (Lithium Heparin), Lavender (K2 EDTA), or Lavender (K3 EDTA).

Specimen Preparation

Allow specimen to clot completely at room temperature. Transfer 1 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.5 mL)

Storage/Transport Temperature

Frozen.

Unacceptable Conditions

Grossly hemolyzed specimens.

Remarks
Stability

Ambient: 5 hours; Refrigerated: 48 hours; Frozen: 3 months

Methodology

Quantitative Electrochemiluminescent Immunoassay

Performed

Sun-Sat

Reported

Within 24 hours

Reference Interval

0-140 pmol/L

Interpretive Data

The Roche Human Epididymis Protein 4 (HE4) electrochemiluminescent immunoassay was used. Results obtained with different test methods or kits cannot be used interchangeably. The HE4 test is used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical findings for monitoring ovarian cancer.

Compliance Category

FDA

Note

Hotline History

N/A

CPT Codes

86305

Components

Component Test Code* Component Chart Name LOINC
2003021 Human Epididymis Prot 4 55180-4
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • HE 4
  • HE4
  • Human HE4 Antigen
Human Epididymis Protein 4 (HE4)