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HE4, Ovarian Cancer Monitoring

Test Summary

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.

Aliases

  • Human Epididymis Protein 4

Specimen Collection

Special Instructions

N/A

Preferred Specimen

0.5 mL serum

Minimum Volume

0.3 mL

Instructions

Sample collected in a red-top tube must be allowed to clot for at least 30 minutes but no longer than 1 hour

Patient Preparation

N/A

Storage

Plastic screw cap vial

Transport Temperature

Frozen

Specimen Stability

  • Room Temperature = 48 hours
  • Refrigerated = 72 hours
  • Frozen = 28 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.

Other Acceptable Specimens

Red top tube
SST (speckled top) tube

Unacceptable Specimens

Gross hemolysis • Lipemia • Icteric specimens • Presence of fibrin, RBCs or other particulate matter • Obvious microbial contamination

Order Code

HE4OCM

EPIC (Premier) Code

LAB4447

Includes

N/A

CPT Code

  • 86305

Billing Code

  • 671006

CPT Statement

Methodology

Chemiluminescent Microparticle Immunoassay (CMIA)

FDA Status

FDA Approved

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Department

Reference Testing

Reference Range

Female Premenopausal≤70 pmol/L
Female Postmenopausal≤140 pmol/L

Setup Schedule / Expected Turnaround Time

Monday, Wednesday, Friday morning; Report available: 5 days

Specimen Collection

Special Instructions

N/A

Preferred Specimen

0.5 mL serum

Minimum Volume

0.3 mL

Instructions

Sample collected in a red-top tube must be allowed to clot for at least 30 minutes but no longer than 1 hour

Patient Preparation

N/A

Storage

Plastic screw cap vial

Transport Temperature

Frozen

Specimen Stability

  • Room Temperature = 48 hours
  • Refrigerated = 72 hours
  • Frozen = 28 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.

Other Acceptable Specimens

Red top tube
SST (speckled top) tube

Unacceptable Specimens

Gross hemolysis • Lipemia • Icteric specimens • Presence of fibrin, RBCs or other particulate matter • Obvious microbial contamination

Billing

CPT Code

  • 86305

Billing Code

  • 671006

CPT Statement

Result Information

Methodology

Chemiluminescent Microparticle Immunoassay (CMIA)

Testing Laboratory

N/A

Reference Range

Female Premenopausal≤70 pmol/L
Female Postmenopausal≤140 pmol/L

Setup Schedule / Expected Turnaround Time

Monday, Wednesday, Friday morning; Report available: 5 days