Overview: CD117 Flow Cytometry TestIntroduction: The CD117 Flow Cytometry Test detects CD117 markers to diagnose leukemia or mast cell disorders, causing fatigue or skin lesions. Following 2023 ASH guidelines, it uses flow cytometry for high specificity, aiding in cancer screening. This test is critical for guiding diagnosis, treatment, and improving outcomes in hematology for patients with suspected leukemia or mast cell disorders.
Other Names: CD117 Flow Assay, c-KIT Test.
FDA Status: Laboratory-developed test (LDT), meeting hematology standards for diagnostic accuracy.
Historical Milestone: CD117 testing began in the 1990s with leukemia and mast cell research. Flow cytometry emerged in the 2000s, improving accuracy for marker detection.
Purpose: Diagnoses leukemia or mast cell disorders, guides treatment, and monitors CD117 markers in patients with fatigue or skin lesions.
Test Parameters: 1. CD117
Pretest Condition: No fasting required. Collect whole blood or bone marrow at any time. Report symptoms like fatigue or skin lesions, and list medications.
Specimen: 2-5 mL whole blood (EDTA) or 2-5 mL bone marrow (EDTA). Transport in a biohazard bag within 24 hours.
Sample Stability at Room Temperature: 24 hours
Sample Stability at Refrigeration: 48 hours
Sample Stability at Frozen: Not frozen
Medical History: Document fatigue, skin lesions, or history of leukemia/mast cell disorders. Include current medications, especially targeted therapies.
Consent: Written consent required, detailing the tests purpose, diagnostic implications, and potential need for cancer therapy.
Procedural Considerations: Uses flow cytometry to detect CD117 markers. Results are available in 1-2 days, enabling rapid clinical decisions.
Factors Affecting Result Accuracy: Poor sample quality or low cell yield can affect results. Non-malignant conditions may express CD117.
Clinical Significance: Positive CD117 expression suggests leukemia or mast cell disorders, prompting treatment. Negative results may require additional marker testing.
Specialist Consultation: Consult a hematologist or oncologist for result interpretation.
Additional Supporting Tests: Bone marrow biopsy, tryptase levels, or other flow cytometry markers to confirm leukemia/mast cell disorders.
Test Limitations: Non-specific expression may occur in non-malignant conditions. Results require clinical correlation.
References: ASH Leukemia Guidelines, 2023; Blood, Arber DA, 2022.
