Overview: CYFRA 21-1 (Cytokeratin 19 Fragment) TestIntroduction: The CYFRA 21-1 Test measures cytokeratin 19 fragment to monitor lung cancer, causing cough or shortness of breath. Following 2023 NCCN guidelines, it uses an immunoassay for high sensitivity, aiding in cancer screening. This test is critical for guiding treatment monitoring, assessing disease progression, and improving outcomes in immunology for patients with suspected lung cancer.
Other Names: CA CYFRA 21-1 Assay, Lung Cancer Marker Test.
FDA Status: Laboratory-developed test (LDT), meeting immunology standards for diagnostic accuracy.
Historical Milestone: CYFRA 21-1 testing began in the 1990s with lung cancer research. Immunoassays emerged in the 2000s, and by the 2010s, high-sensitivity assays improved monitoring accuracy.
Purpose: Monitors lung cancer, guides treatment, and assesses disease progression in patients with cough or shortness of breath.
Test Parameters: 1. CA CYFRA 21-1
Pretest Condition: No fasting required. Collect serum or plasma at any time. Report symptoms like cough or shortness of breath, and list medications like chemotherapy.
Specimen: 2-5 mL serum (SST) or 2-4 mL plasma (EDTA). Centrifuge within 1 hour. Transport in a biohazard bag within 8 hours.
Sample Stability at Room Temperature: 8 hours
Sample Stability at Refrigeration: 7 days
Sample Stability at Frozen: 6 months
Medical History: Document cough, shortness of breath, or family history of lung cancer. Include current medications, especially chemotherapy or targeted therapies.
Consent: Written consent required, detailing the tests purpose, diagnostic implications, and potential need for cancer treatment.
Procedural Considerations: Uses an immunoassay to measure CYFRA 21-1 levels. Results are available in 3-5 days, supporting clinical decisions.
Factors Affecting Result Accuracy: Benign lung conditions like pneumonia may elevate CYFRA 21-1 levels. Hemolysis or improper storage can degrade samples.
Clinical Significance: Elevated CYFRA 21-1 levels indicate lung cancer progression, prompting chemotherapy or radiation. Normal levels suggest stable disease or remission.
Specialist Consultation: Consult an oncologist for result interpretation. A pulmonologist referral is advised for lung cancer cases.
Additional Supporting Tests: Chest CT, PET scan, or NSE test to confirm lung cancer or assess disease extent.
Test Limitations: False positives may occur with benign lung conditions. Results require clinical correlation with imaging.
References: NCCN Lung Cancer Guidelines, 2023; Journal of Clinical Oncology, Ettinger DS, 2022.
