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HE4, Ovarian Cancer Monitoring
Test Code16500
CPT Codes
86305
Preferred Specimen
0.5 mL serum
Minimum Volume
0.3 mL
Other Acceptable Specimens
Serum submitted in a serum separator tube (SST®)
Instructions
Sample collected in a red-top tube must be allowed to clot for at least 30 minutes but no longer than 1 hour
Transport Container
Red-top tube (no gel)
Transport Temperature
Frozen
Specimen Stability
Room temperature: 48 hours
Refrigerated: 72 hours
Frozen: 28 days
Refrigerated: 72 hours
Frozen: 28 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Lipemia • Icteric specimens • Presence of fibrin, RBCs or other particulate matter • Obvious microbial contamination
Methodology
Chemiluminescent Microparticle Immunoassay (CMIA)
Setup Schedule
Set up: Mon, Wed, Fri a.m.; Report available: 5 days
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
| Female Premenopausal | ≤70 pmol/L |
| Female Postmenopausal | ≤140 pmol/L |
Clinical Significance
The percentage increase in HE4 values has been used as an aid in monitoring recurrence or progressive disease in patients with invasive epithelial ovarian cancer. Currently there is no clinically accepted cut-off for use in monitoring cancer progression in epithelial ovarian cancer subjects with this assay. Serial testing for patient HE4 assay values should be used in conjunction with methods used for monitoring ovarian cancer.
