Overview: Cytokeratin 7 Immunohistochemistry TestIntroduction: The Cytokeratin 7 Immunohistochemistry Test detects cytokeratin 7 (CK7) to diagnose lung or breast cancer, causing cough or lumps. Aligned with 2023 NCCN guidelines, it uses immunohistochemistry for high specificity, supporting cancer screening. This test is critical for guiding diagnosis, treatment planning, and improving outcomes in histopathology for patients with suspected lung or breast malignancies.
Other Names: CK7 IHC Assay, Lung/Breast Cancer IHC Test.
FDA Status: Laboratory-developed test (LDT), meeting histopathology standards for diagnostic accuracy.
Historical Milestone: CK7 testing began in the 1990s with lung and breast cancer research. Immunohistochemistry-based methods improved in the 2000s, enhancing diagnostic precision.
Purpose: Detects CK7 to diagnose lung or breast cancer, guides treatment, and evaluates patients with cough or lumps.
Test Parameters: 1. Cytokeratin 7 Protein
Pretest Condition: No fasting required. Collect tissue via biopsy or surgical resection. Report history of cough, chest pain, or breast lumps.
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 cough, chest pain, breast lumps, or family history of lung or breast cancer. Include current medications, especially chemotherapy.
Consent: Written consent required, detailing the tests purpose, cancer implications, and risks of biopsy or surgery.
Procedural Considerations: Uses immunohistochemistry to detect CK7 in lung or breast tissue. Results are available in 1-2 days, supporting rapid clinical decisions. Performed in laboratories, often for lung or breast cancer diagnosis.
Factors Affecting Result Accuracy: Improper tissue fixation or processing can affect results. Low tissue quality may reduce staining accuracy.
Clinical Significance: Positive CK7 staining suggests lung or breast cancer, guiding surgery or chemotherapy. Negative staining may require further marker testing (e.g., CK20).
Specialist Consultation: Consult an oncologist or pulmonologist for result interpretation and treatment planning.
Additional Supporting Tests: CK20 IHC, TTF-1 IHC, or mammogram to confirm lung or breast cancer diagnosis.
Test Limitations: Not specific to one cancer type; other tumors (e.g., ovarian) may express CK7. Clinical correlation is needed.
References: NCCN Lung Cancer Guidelines, 2023; American Journal of Surgical Pathology, Chu PG, 2022.
