|
**Overview**: Ovarian Cancer Panel**Introduction**: The Ovarian Cancer Panel is a diagnostic tool designed to screen for ovarian cancer using serum samples. In India, ovarian cancer affects ~45,000 new cases/year (high mortality due to late diagnosis), with CA-125 elevated in ~80 percent of epithelial ovarian cancers (stage III/IV common) and HE4 improving specificity in postmenopausal women. High morbidity from under-testing in rural/low-SES women with abdominal bloating, pelvic pain, or ascites, limited tumor marker labs, delayed surgical staging/chemotherapy leading to advanced disease or poor survival. Per oncology practices aligned with ICMR and Indian Society of Medical & Pediatric Oncology guidelines, the test employs immunoassay for CA-125 and HE4 over 1-2 days with high accuracy, valuable for risk assessment (ROMA score) in symptomatic or high-risk women. This diagnostic falls under cancer screening and targets postmenopausal women with pelvic mass or symptoms, addressing accurate detection to guide imaging, biopsy, or debulking surgery. With elevated morbidity due to underdiagnosis, the test supports public health efforts by enabling early marker detection and improving ovarian cancer outcomes. Its serum-based approach ensures reliable tumor marker quantification.**Other Names**: Ovarian Ca Pnl.**FDA Status**: FDA approved, CLIA certified for oncology/endocrinology, compliant with 2025 standards.**Historical Milestone**: CA-125/HE4 panel standard; in India, used in gynae-oncology.**Purpose**: The test assesses 2 parameters including CA-125 to guide ovarian cancer screening, assess tumor markers, inform diagnostic workup.**Test Parameters**: 1. CA-125, 2. HE4.**Pretest Condition**: Fasting 10-12 hours recommended; patients should report pelvic symptoms.**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 bloating, family cancer history.**Consent**: Written informed consent is required, detailing the test's purpose, potential risks of undetected cancer 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 interpret results 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, or benign conditions (endometriosis) can affect results. Correlation with clinical evaluation or additional testing is recommended to confirm findings.**Clinical Significance**: Elevated CA-125/HE4 indicates high malignancy risk, necessitating specialist input.**Specialist Consultation**: Gynecologic oncologists should be consulted for management.**Additional Supporting Tests**: Transvaginal ultrasound, ROMA score for confirmation.**Test Limitations**: Not specific (elevated in benign conditions); comprehensive approach required.**References**: Indian Journal of Medical Oncology 2024, Ovarian Cancer Studies India 2023. |
