HE4, Ovarian Cancer Monitoring

Last Modified: 5/2/2022 1:46:09 PM


Medical Necessity Documentation:  
Client Notes:  
Patient Preparation:  
Specimen Requirements:

1.0 mL Serum from a Red Top Tube in a Plastic Vial
Collection Instructions: Sample collected must be allowed to clot for at least 30 minutes but no longer than 1 hour
Minimum Volume: 0.3 mL Serum
Transport & Storage: Temperature/Stability: 48 hours Ambient
72 hours Refrigerated
28 days Frozen
Rejection Criteria: Gross hemolysis • Lipemia • Icteric specimens • Presence of fibrin, RBCs or other particulate matter • Obvious microbial contamination
Reference Range:
Female Premenopausal ≤70 pmol/L
Female Postmenopausal ≤140 pmol/L
Critical Ranges:  
Test Comments: 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.
Methodology: Chemiluminescent Microparticle Immunoassay (CMIA)
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.
Documentation:  
Custom Panel: No

PRODUCTION SCHEDULE

Turn Around Time: 3 to 6 days
Days Performed: Monday, Wednesday, Friday
Sites Performed: Quest - Chantilly to San Juan Capistrano
PHL Test Code: MSOT
EPIC Test Code:
Send Out Test Code: 16500
Alternate Test Names: Human Epididymis Protein 4
Included Tests:  
CPT Coding: 86305

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