Overview: Ki67 Immunohistochemistry TestIntroduction: The Ki67 Immunohistochemistry Test detects Ki67 protein to assess tumor growth rate, aiding cancer prognosis. Following 2023 WHO guidelines, it uses immunohistochemistry for high specificity, supporting cancer screening. This test is critical for guiding prognosis, treatment planning, and improving outcomes in histopathology for patients with various cancers.
Other Names: Ki67 IHC Assay, Tumor Proliferation IHC Test.
FDA Status: Laboratory-developed test (LDT), meeting histopathology standards for diagnostic accuracy.
Historical Milestone: Ki67 testing began in the 1980s with cancer proliferation research. Immunohistochemistry-based methods improved in the 2000s, enhancing prognostic precision.
Purpose: Detects Ki67 to assess tumor growth rate, guides treatment, and evaluates cancer prognosis.
Test Parameters: 1. Ki67 Protein
Pretest Condition: No fasting required. Collect tissue via biopsy or surgical resection. Report history of cancer diagnosis or symptoms.
Specimen: 0.5-2 cma³ tissue (FFPE). Transport in a biohazard container.
Sample Stability at Room Temperature: 7 days
Sample Stability at Refrigeration: Not refrigerated
Sample Stability at Frozen: Not frozen
Medical History: Document cancer history, tumor type, or symptoms (e.g., lumps, pain). Include current medications, especially chemotherapy.
Consent: Written consent required, detailing the tests purpose, prognostic implications, and risks of biopsy or surgery.
Procedural Considerations: Uses immunohistochemistry to detect Ki67 in tumor tissue. Results are available in 1-2 days, supporting rapid clinical decisions. Performed in laboratories, often for cancer prognosis.
Factors Affecting Result Accuracy: Improper tissue fixation or processing can affect results. Low tissue quality may reduce staining accuracy.
Clinical Significance: High Ki67 staining indicates aggressive tumor growth, guiding intensive therapy. Low Ki67 suggests slower growth, potentially less aggressive treatment.
Specialist Consultation: Consult an oncologist for result interpretation and treatment planning.
Additional Supporting Tests: Tumor-specific IHC (e.g., HER-2, ER/PR), or PET-CT to assess cancer prognosis.
Test Limitations: Ki67 levels vary by tumor type; clinical correlation is needed. Not diagnostic on its own.
References: WHO Tumor Classification Guidelines, 2023; American Journal of Surgical Pathology, Gerdes J, 2022.
