Human Epididymis Protein 4 (HE4)

2003020
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Additional Technical Information

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.

Mnemonic

HE4

Methodology

Quantitative Electrochemiluminescent Immunoassay

Performed

Sun-Sat

Reported

Within 24 hours

New York DOH Approval Status

This test is New York DOH 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

Reference Interval

0-140 pmol/L

Interpretive Data

Human Epididymis Protein 4 (HE4) is to be 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. ARUP uses the Roche Cobas e602 electrochemiluminescent assay. Values obtained with different assay methods should not be used interchangeably.

Compliance Category

FDA

Note

Hotline History

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
05/17/2021
X
N/A

CPT Codes

86305

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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)