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Clear
 
Test Code:
090-30-2332-01

Order Name:
HE4

 
Useful For:
Used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is further intended to be used in conjunction with CA 125 as an aid in estimating the risk of epithelial ovarian cancer in premenopausal and postmenopausal women presenting with an adnexal mass who will
undergo surgical intervention. The results must be interpreted in conjunction with other methods in accordance with standard clinical management guidelines.
 
Methodology:
Chemiluminescent Microparticle Immuno Assay (CMIA)
 
 
 
Test Code:
090-30-2332-01

Order Name:
HE4

 
Collection Specimen Or Container:
Plain Blood 6 mL (Red Top) 1 tube
 
Specimen Testing Type:
Serum, minimum volume 0.5 mL
 
Sub Mission Container:
Plastic vial
 
Rejection Criteria:
Hemolysis: 4+ reject
 
Specimen Stabillity:
Specimen Type Temperature Time
Serum (keep in original tube) Room Temperature 8 hours
Serum Refrigerated, 2oC to 8oC 7 days
Frozen, -10oC 14 days
 
 
 
Test Code:
090-30-2332-01

Order Name:
HE4

 
Method detail:
Chemiluminescent Microparticle Immuno Assay (CMIA)
 
Schedule:
Tested daily (24 hours)
 
 
Turnaround Time:
Specimen collected to reported within 2:00 Hours (120 Mins)
 
Performing Location:
Immunology, Laboratory Department Tel. 13227
 
Specimen Retention Time:
5 days
 
 
 
Test Code:
090-30-2332-01

Order Name:
HE4

 
 
Clinical Information:
Human epididymis protein 4 (HE4) belongs to the family of whey acidic four-disulfide core (WFDC) proteins. Currently, the biologic function of HE4 is unknown.
HE4 has been shown to be overexpressed in 93% of serous, 100% of endometrioid, and 50% of clear cell ovarian carcinomas. In a study of 233 patients with a pelvic mass, including 67 with epithelial ovarian cancer, HE4 had a higher sensitivity for ovarian cancer detection than cancer antigen 125 (CA 125), 72.9% versus 43.3%, respectively, at a specificity of 95%. Researchers also found HE4 to be elevated in more than half of the ovarian cancer patients who did not have elevated CA 125 levels; therefore, the combination of markers provided slightly improved cancer diagnostic sensitivity for the detection of ovarian cancer.
The main established application of HE4 is in post-therapy monitoring of ovarian cancer patients, who had elevated pretreatment levels. In this setting, it complements CA 125 measurement and facilitates follow-up of patients with little or no CA 125 pretreatment elevations.
Certain histological types of ovarian cancer (mucinous or germ cell tumors) rarely express HE4, therefore the use of HE4 is not recommended for monitoring of patients with these types of ovarian cancer.
 
Reference Value:
For premenopausal patient = 0-70 pmol/L
For postmenopausal patient = 0-140 pmol/L
 
Clinical Reference:
1. Manufacturer’s Reagent package insert Architect HE4, November 2015, Abbott GmbH &Co.KG, MAX-Planck-Ring 2, 65205 Wiesbaden, Germany.
2. www.mayoclinic.com (Retreived : Jan 2021)