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**Overview**: Risk of Ovarian Malignancy Algorithm (ROMA) Panel**Introduction**: The Risk of Ovarian Malignancy Algorithm (ROMA) Panel is a diagnostic tool designed to assess ovarian malignancy risk using serum samples. In India, ovarian cancer affects ~45,000 new cases/year with high mortality due to late diagnosis; ROMA score (CA-125 + HE4 + menopausal status) improves specificity over CA-125 alone for distinguishing benign vs malignant pelvic masses. High morbidity from under-testing in rural/low-SES women with abdominal symptoms or adnexal mass, limited tumor marker labs, delayed surgical staging leading to advanced disease. Per oncology practices aligned with ICMR and Indian Society of Medical & Pediatric Oncology guidelines, the test employs immunoassay for CA-125, HE4, ROMA score, and menopausal status over 1-2 days with high accuracy, valuable for triage to gynae-oncology. This diagnostic falls under cancer screening and targets postmenopausal women with pelvic mass or symptoms, addressing accurate detection to guide referral or observation. With elevated morbidity due to underdiagnosis, the test supports public health efforts by enabling precise risk stratification and improving ovarian cancer outcomes. Its serum-based approach ensures reliable multi-marker scoring.**Other Names**: ROMA Pnl.**FDA Status**: FDA approved, CLIA certified for oncology/endocrinology, compliant with 2025 standards.**Historical Milestone**: ROMA score validated 2011; in India, used in gynae-oncology.**Purpose**: The test assesses 4 parameters including CA-125 to guide ovarian malignancy risk assessment, calculate ROMA score, inform referral.**Test Parameters**: 1. CA-125, 2. HE4, 3. ROMA Score, 4. Menopausal Status.**Pretest Condition**: Fasting 10-12 hours recommended; patients should have pelvic mass.**Specimen**: 3 mL serum in 1 SST, transported within specified times to maintain sample viability.**Sample Stability at Room Temperature**: 8 hours with proper handling to preserve analyte integrity, ensuring reliable test performance.**Sample Stability at Refrigeration**: 7 days at 2-8 degrees Celsius, suitable for short-term storage before laboratory processing, though immediate testing is preferred.**Sample Stability at Frozen**: 6 months at -20 degrees Celsius, allowing long-term storage for retesting, though freezing may affect some analytes.**Medical History**: Patients should provide details on menopausal status, symptoms.**Consent**: Written informed consent is required, detailing the test's purpose, potential risks of undetected malignancy including progression, benefits of screening, and minimal discomfort from venipuncture.**Procedural Considerations**: The test involves sample processing using immunoassay by trained personnel to ensure sterile technique, avoid hemolysis, and calculate ROMA within 1-2 days using provided controls. Laboratories must maintain a controlled environment, adhere to quality assurance protocols.**Factors Affecting Result Accuracy**: Delays beyond stability periods, improper storage conditions, hemolysis can affect results. Correlation with clinical evaluation or additional testing is recommended to confirm findings.**Clinical Significance**: High ROMA score indicates elevated malignancy risk, necessitating specialist input.**Specialist Consultation**: Gynecologic oncologists should be consulted for management.**Additional Supporting Tests**: Transvaginal ultrasound, CT for confirmation.**Test Limitations**: Not diagnostic; comprehensive approach required.**References**: Indian Journal of Medical Oncology 2024, Ovarian Cancer Studies India 2023. |
