Human Epididymis Protein 4
Use
The HE4 assay is utilized as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing using HE4 assay values should be integrated with other clinical findings for monitoring ovarian cancer. The test shows potential in differentiating ovarian cancer from other types of ovarian conditions.
Special Instructions
Values obtained with different assay methods should not be used interchangeably during serial testing. It is recommended to consistently use only one assay method to monitor each patient's therapy course. The procedure is intended for one-time use only. For serial monitoring, test 481700 is recommended. The test may show interference if the sample is collected from a person consuming high doses of biotin. Patients should be advised to stop biotin usage at least 72 hours prior to sample collection.
Limitations
The HE4 assay is not intended for use as a cancer screening test. HE4 levels may be influenced by age and menstruation onset age, but these effects are minor. In samples with human antimouse antibodies, HE4 values can be falsely altered. The presence of HE4 within the reference range doesn't exclude cancer, and high levels do not definitively indicate malignancy. Certain ovarian cancer types do not express HE4 and the Elecsys HE4 assay is not advised for monitoring mucinous or germ cell ovarian cancer. HE4 may show elevated levels in individuals with non-malignant diseases. Results need to be evaluated along with other clinical laboratory findings.
Methodology
Immunoassay (ECLIA)
Biomarkers
LOINC Codes
- 55180-4
- 55180-4
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.8 mL
Minimum Volume
0.4 mL
Container
Red-top tube or gel-barrier tube
Collection Instructions
If red-top tube is used, transfer separated serum to a plastic transport tube.
Patient Preparation
No special patient preparations are required.
Storage Instructions
Refrigerate
Causes for Rejection
Nonserum sample received
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 5 days |
| Refrigerated | 14 days |
| Frozen | 14 days |