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Clear
 
Test Code:
090-30-2333-01

Order Name:
HE4 and CA125 with ROMA

 
Useful For:
Classified patients as presenting a high or low risk for epithelial ovarian cancer (EOC).
 
Methodology:
Chemiluminescent Microparticle Immuno Assay (CMIA)
 
Test List In Profile:
HE4
CA 125
 
AliasesName:
ROMA Score (Ovarian Malignancy Risk Algorithm)
ROMA Score
 
 
 
Test Code:
090-30-2333-01

Order Name:
HE4 and CA125 with ROMA

 
Collection Specimen Or Container:
Blood/ Plain Blood (Red Top) 6 mL, 1 tube
 
Specimen Testing Type:
Serum, minimum volume 2 mL
 
Sub Mission Container:
Plastic vial
 
Rejection Criteria:
Hemolysis: 4+ reject
 
Specimen Stabillity:
Specimen Type Temperature Time
Serum (keep in original tube) Refrigerated, 2oC to 8oC 8 hours
Serum Refrigerated, 2oC to 8oC 4 days
Frozen, -20oC 7 days
 
 
 
Test Code:
090-30-2333-01

Order Name:
HE4 and CA125 with ROMA

 
Method detail:
Chemiluminescent Microparticle Immuno Assay (CMIA)
 
Schedule:
Tested daily (24 hours)
 
Turnaround Time:
Collected specimen to report within 2 hours (120 mins)
 
Performing Location:
Immunology, Laboratory Department Tel. 13227
 
Specimen Retention Time:
5 days
 
 
 
Test Code:
090-30-2333-01

Order Name:
HE4 and CA125 with ROMA

 
 
Clinical Information:
Women with ovarian cancer symptoms and adnexal masses present primarily to gynecologists, primary care physicians or general surgeons. Triage guidelines from the American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists recommends referral of women with a pelvic mass at high risk for ovarian cancer to gynecologic oncologists. Specialized treatment improves patient outcomes resulting in fewer complications and better survival rates when compared to patients treated by surgeons less familiar with the management of ovarian cancer.

The risk of ovarian malignancy algorithm (ROMA) incorporates cancer antigen 125 (CA125), human epididymal protein 4 (HE4), and menopausal status to assign women that present with an adnexal mass into a high-risk or low-risk group for finding an ovarian malignancy. ROMA is indicated for women who meet the following criteria: older than age 18, presenting with an adnexal mass for which surgery is planned,  and who have not yet been referred to an oncologist. ROMA must be interpreted in conjunction with clinical and radiological assessment.
 
Reference Value:
Parameters Reference value Unit
CA 125 0 - 35.0 U/mL
HE4
     - premenopausal patient
     - postmenopausal patient

0 - 70
0 - 140

pmol/L
 
pmol/L

Risk of Ovarian Malignancy Algorithm (ROMA)
  • Premenopausal Patients:
           ROMA value ≥ 7.4% = High risk of finding epithelial ovarian cancer 
           ROMA value < 7.4% = Low risk of finding epithelial ovarian cancer 
  • Postmenopausal Patients:
           ROMA value ≥ 25.3% = High risk of finding epithelial ovarian cancer 
           ROMA value < 25.3% = Low risk of finding epithelial ovarian cancer 
 
Clinical Reference:
  1. Manufacturer’s Reagent package insert Architect  CA 125 II, November 2015, Abbott Laboratories, Diagnostic Division, Abbott Park IL 60064 USA.
  2. Manufacturer’s Reagent package insert Architect  HE4, November 2015, Abbott GmbH &Co.KG, MAX-Planck-Ring 2, 65205 Wiesbaden, Germany.