HE4, Ovarian Cancer Monitoring

Test Code
16500

CPT Codes
86305

Preferred Specimen
0.5 mL serum

Minimum Volume
0.1 mL

Transport Container
Plastic screw-cap vial

Transport Temperature
Room temperature

Specimen Stability
Room temperature: 5 days
Refrigerated: 7 days
Frozen: 28 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Hemolysis • Lipemia • Specimens with heavy particulate matter • Icteric specimens

Methodology
Immunoassay (IA)

Limitations

A clinical study indicated that serial HE4 levels correlated with clinical status (progression vs. no progression) in 70% (247/354) of the study participants.

Reference Range
<151 pM

Clinical Significance
The HE4 EIA assay is an enzyme immunoassay for the quantitative determination of human HE4 antigen in serum. HE4 is a biomarker for ovarian cancer.