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Overview
ข้อมูลทั่วไป Specimen
ข้อมูลสิ่งส่งตรวจ Performance
ข้อมูลการทดสอบ Clinical & Interpretation
ข้อมูลทางคลินิก

Test Code (รหัสการทดสอบ):

090-30-2333-01

Order Name (ชื่อการทดสอบ):

HE4 and CA125 with ROMA

Specimen / Container (สิ่งส่งตรวจ/ภาชนะ):

Blood/ Plain Blood (Red Top) 6 mL, 1 tube

Turnaround Time (ระยะเวลารอผล):

Collected specimen to report within 2 hours (120 mins)

Useful For (ประโยชน์การทดสอบ):

Classified patients as presenting a high or low risk for epithelial ovarian cancer (EOC).

Methodology (วิธีการทดสอบ):

Chemiluminescent Microparticle Immuno Assay (CMIA)

Test List In Profile (การทดสอบใน Profile):

HE4
CA 125

AliasesName (ชื่อเรียกอื่นๆ) :

ROMA Score (Ovarian Malignancy Risk Algorithm)
ROMA Score

Test Code (รหัสการทดสอบ):

090-30-2333-01

Order Name (ชื่อการทดสอบ):

HE4 and CA125 with ROMA

Collection Specimen Or Container (สิ่งส่งตรวจ/ภาชนะ):

Blood/ Plain Blood (Red Top) 6 mL, 1 tube

Specimen Testing Type (สิ่งส่งตรวจที่ใช้ในการทดสอบ):

Serum, minimum volume 2 mL

Sub Mission Container (ภาชนะส่งตรวจ):

Plastic vial

Rejection Criteria (เกณฑ์ปฏิเสธสิ่งส่งตรวจ):

Hemolysis: 4+ reject

Specimen Stabillity (ความคงตัวของสิ่งส่งตรวจ):

Specimen Type	Temperature	Time
Serum (keep in original tube)	Refrigerated, 2^oC to 8^oC	8 hours
Serum	Refrigerated, 2^oC to 8^oC	4 days
Serum	Frozen, -20^oC	7 days

Test Code (รหัสการทดสอบ):

090-30-2333-01

Order Name (ชื่อการทดสอบ):

HE4 and CA125 with ROMA

Method detail (วิธีการทดสอบ):

Chemiluminescent Microparticle Immuno Assay (CMIA)

Schedule (ตารางการทดสอบ):

Tested daily (24 hours)

Turnaround Time (ระยะเวลารอผล):

Collected specimen to report within 2 hours (120 mins)

Performing Location (หน่วยงานที่ทำการทดสอบ):

Immunology, Laboratory Department Tel. 13227

Specimen Retention Time (ระยะเวลาเก็บสิ่งส่งตรวจ):

5 days

Test Code (รหัสการทดสอบ):

090-30-2333-01

Order Name (ชื่อการทดสอบ):

HE4 and CA125 with ROMA

Clinical Information (ข้อมูลทางคลินิก):

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 (ค่าอ้างอิง):

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 (เอกสารอ้างอิง):

Manufacturer’s Reagent package insert Architect CA 125 II, November 2015, Abbott Laboratories, Diagnostic Division, Abbott Park IL 60064 USA.
Manufacturer’s Reagent package insert Architect HE4, November 2015, Abbott GmbH &Co.KG, MAX-Planck-Ring 2, 65205 Wiesbaden, Germany.