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CYFRA 21-1
Cancer
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No Fasting Required
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Tumor marker (fragment of cytokeratin 19).
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CYFRA 21-1 Test Information Guide
- Why is it done?
- CYFRA 21-1 is a tumor marker test that measures cytokeratin 19 fragment in blood serum. It is a protein released by cancer cells, particularly epithelial cells.
- Primary use: Detection, monitoring, and prognostic assessment of non-small cell lung cancer (NSCLC), particularly squamous cell carcinoma and adenocarcinoma.
- Secondary applications: Monitoring ovarian cancer, bladder cancer, esophageal cancer, head and neck cancers, and other epithelial malignancies.
- Timing: Performed at initial diagnosis, during treatment monitoring, after completion of therapy, and during surveillance for cancer recurrence.
- Assessment of treatment response: Serial measurements help evaluate effectiveness of chemotherapy, immunotherapy, or radiation therapy.
- Normal Range
- Normal/Reference Range: Less than 3.3 ng/mL (nanograms per milliliter)
- Borderline/Elevated Range: 3.3 to 6.0 ng/mL (may warrant further investigation)
- Significantly Elevated: Greater than 6.0 ng/mL (suggests possible malignancy or cancer progression)
- Units: ng/mL (nanograms per milliliter) or ng/L (nanograms per liter)
- Normal Result: Values below the cutoff suggest absence of significant epithelial cell damage or malignancy; however, normal values do not exclude cancer.
- Abnormal Result: Elevated levels suggest possible malignancy, advanced disease, or tissue damage; should be interpreted with clinical findings and imaging studies.
- Interpretation
- Negative/Low Values (Less than 3.3 ng/mL):
- Generally indicates no significant epithelial cell malignancy detected.
- Does not completely rule out early-stage cancer or some types of malignancy.
- Moderately Elevated (3.3 to 6.0 ng/mL):
- Warrants further investigation with imaging (CT scan, PET scan) and clinical correlation.
- May indicate benign conditions or early malignancy.
- Significantly Elevated (Greater than 6.0 ng/mL):
- Suggests probable malignancy or advanced cancer disease.
- Correlates with tumor burden and may indicate poor prognosis.
- Serial Measurement Interpretation:
- Decreasing levels: Indicates positive treatment response and disease control.
- Increasing levels: Suggests cancer progression or treatment failure.
- Stable levels: May indicate stable disease or need for treatment adjustment.
- Factors Affecting Results:
- Benign lung diseases: Chronic obstructive pulmonary disease (COPD), pneumonia, pulmonary fibrosis, tuberculosis may cause mild elevation.
- Liver disease: Hepatitis, cirrhosis may elevate levels.
- Renal dysfunction: Impaired clearance may result in increased levels.
- Smoking history: Current smokers may have baseline elevation.
- Recent chemotherapy or radiation: May temporarily elevate levels due to cell damage.
- Negative/Low Values (Less than 3.3 ng/mL):
- Associated Organs
- Primary Organ System:
- Respiratory system (lungs) - primary target organ, especially the airways and lung epithelium.
- Cancers Associated with Abnormal Results:
- Non-small cell lung cancer (NSCLC): Most common association, particularly squamous cell carcinoma and adenocarcinoma.
- Ovarian cancer: Elevated in 50-70% of advanced stage cases.
- Bladder cancer: Elevated in majority of patients with advanced disease.
- Esophageal cancer: Frequently elevated in advanced cases.
- Head and neck cancers: Laryngeal and pharyngeal malignancies.
- Gastric cancer: May be elevated in advanced stages.
- Breast cancer: May show elevation in advanced metastatic disease.
- Benign Conditions Associated with Elevation:
- Chronic obstructive pulmonary disease (COPD)
- Pulmonary fibrosis
- Tuberculosis and other chronic infections
- Pneumonia (acute or chronic)
- Cirrhosis and advanced liver disease
- Potential Complications of Abnormal Results:
- Disease progression: Elevated levels correlate with advanced cancer stage and reduced survival rates.
- Metastatic spread: High levels may indicate systemic disease or distant metastases.
- Recurrence: Rising levels after treatment may signal cancer recurrence requiring intervention.
- Primary Organ System:
- Follow-up Tests
- If Results are Elevated:
- Chest CT scan: To evaluate lung parenchyma, identify nodules, or assess tumor extent.
- PET-CT scan: To identify areas of metabolic activity and metastatic disease.
- Chest X-ray: Initial imaging modality for lung assessment.
- Bronchoscopy or tissue biopsy: If lung lesion identified to obtain pathological confirmation.
- CEA (Carcinoembryonic antigen): Complementary tumor marker for lung and other cancers.
- NSE (Neuron-specific enolase): For small cell lung cancer evaluation.
- Laboratory Tests for Differential Diagnosis:
- Comprehensive metabolic panel: To assess liver and kidney function.
- Complete blood count: To evaluate for anemia or blood cell abnormalities.
- Liver function tests: If hepatic metastases or liver disease suspected.
- Monitoring During Treatment:
- Repeat CYFRA 21-1 measurements: Every 4-12 weeks during active cancer treatment to assess response.
- Imaging studies: Periodic CT scans (every 2-3 months) to correlate with tumor marker trends.
- Combination marker panel: CYFRA 21-1 combined with CEA, NSE, or other markers for improved sensitivity.
- Surveillance and Follow-up Schedule:
- Post-treatment: Every 3 months for first year, then every 6-12 months if disease-free.
- Long-term follow-up: Annual or as clinically indicated for at least 5 years.
- If Results are Elevated:
- Fasting Required?
- Fasting Required: NO
- The CYFRA 21-1 test does not require fasting. You may eat and drink normally before the test.
- Sample Collection:
- A simple blood draw from a vein is performed (usually from the arm).
- Blood is collected in a sterile tube and processed in the laboratory.
- The entire procedure takes only a few minutes.
- Special Instructions/Patient Preparation:
- No special dietary restrictions needed before the test.
- Wear comfortable, loose-fitting clothing that allows easy access to veins.
- Stay well-hydrated with water before the blood draw.
- Avoid strenuous exercise immediately before the test.
- Inform the healthcare provider of any blood disorders or medications affecting bleeding.
- Medications:
- No medications need to be avoided before CYFRA 21-1 testing.
- Continue taking all prescribed medications as directed.
- Anticoagulants (blood thinners) do not interfere with the test but inform the phlebotomist.
- Result Timeline:
- Results typically available within 2-5 business days after blood collection.
- Rush or stat testing may be available in certain clinical situations.
How our test process works!

