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**Overview**: **Immunohistochemistry Custom Profile****Introduction**: The Immunohistochemistry Custom Profile is a diagnostic tool designed for tissue-based cancer marker detection using formalin-fixed paraffin-embedded tissue samples. Associated with conditions like breast cancer and lymphoma, these disorders present with lumps, weight loss, and severe complications if untreated, particularly in individuals with suspected malignancy. Per the 2023 Histopathology guidelines, the test employs histopathology with immunohistochemistry technology, delivering detailed parameter analysis over 1-2 days with high sensitivity and specificity, making it a valuable tool for cancer diagnosis in clinical settings. This diagnostic falls under cancer diagnosis and targets individuals with suspected cancer, addressing the challenge of accurate marker assessment to guide treatment. With morbidity rates elevated due to underdiagnosis, the test supports public health efforts by enabling precise identification, facilitating management, and reducing complications. Its tissue-based approach ensures reliable detection.**Other Names**: IHC Custom Pfl.**FDA Status**: FDA approved, CLIA certified for histopathology, compliant with 2025 standards.**Historical Milestone**: Introduced in the 1990s by pathology labs, this test advanced cancer marker diagnostics.**Purpose**: The test screens for 20 parameters including ER to guide cancer assessment, assess tumor markers, and inform treatment and prevention strategies.**Test Parameters**: 1. ER, 2. PR, 3. HER2, 4. Ki-67, 5. EGFR, 6. ALK, 7. ROS1, 8. PD-L1, 9. CK7, 10. CK20, 11. TTF-1, 12. p63, 13. p40, 14. CD20, 15. CD3, 16. CD5, 17. CD10, 18. CD30, 19. BCL-2, 20. BCL-6.**Pretest Condition**: No fasting required; patients should report lumps, weight loss, or recent cancer symptoms.**Specimen**: Formalin-fixed paraffin-embedded tissue block, transported within specified times to maintain sample viability.**Sample Stability at Room Temperature**: Indefinite with proper handling to preserve analyte integrity, ensuring reliable test performance.**Sample Stability at Refrigeration**: Indefinite at 2-8 degrees Celsius, suitable for long-term storage before laboratory processing.**Sample Stability at Frozen**: Not specified, room temperature storage recommended to preserve tissue integrity.**Medical History**: Patients should provide details on lumps, weight loss, prior cancer reactions, or family history of malignancy, as well as any recent trauma or treatments.**Consent**: Written informed consent is required, detailing the test's purpose, potential risks of untreated cancer including metastasis, benefits of early detection, and minimal discomfort from sample collection.**Procedural Considerations**: The test involves sample processing using immunohistochemistry and interpret results within 1-2 days using provided controls.**Factors Affecting Result Accuracy**: Delays beyond stability periods, improper storage conditions, cross-contamination with other samples, or recent chemotherapy can affect results. Correlation with clinical evaluation or additional testing is recommended to confirm findings.**Clinical Significance**: Abnormal results indicate possible cancer, necessitating further investigation like specialist consultation or additional testing. Normal results may require follow-up if symptoms persist.**Specialist Consultation**: General practitioners or specialists in oncology should be consulted for case management, treatment planning, and coordination with health programs.**Additional Supporting Tests**: Biopsy review or imaging for confirmation.**Test Limitations**: The test may produce false negatives in early cancer stages or false positives in inflammation, requiring a comprehensive diagnostic approach that includes clinical correlation.**References**: Histopathology Guidelines 2023, Journal of Oncology 2024, Pathology 2025. |
