Overview: CD61 Flow Cytometry TestIntroduction: The CD61 Flow Cytometry Test detects CD61 markers to diagnose platelet disorders, causing bleeding or clotting issues. Aligned with 2023 ASH guidelines, it uses flow cytometry for high specificity, aiding in hematological screening. This test is critical for guiding diagnosis, treatment, and improving outcomes in hematology for patients with suspected platelet disorders.
Other Names: CD61 Flow Assay, Integrin Beta 3 Test.
FDA Status: Laboratory-developed test (LDT), meeting hematology standards for diagnostic accuracy.
Historical Milestone: CD61 testing began in the 1990s with platelet research. Flow cytometry emerged in the 2000s, improving accuracy for marker detection.
Purpose: Diagnoses platelet disorders, guides treatment, and monitors CD61 markers in patients with bleeding or clotting issues.
Test Parameters: 1. CD61
Pretest Condition: No fasting required. Collect whole blood or bone marrow at any time. Report symptoms like bleeding or clotting issues, 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 bleeding, clotting issues, or history of platelet disorders. Include current medications, especially anticoagulants.
Consent: Written consent required, detailing the tests purpose, diagnostic implications, and potential need for therapy.
Procedural Considerations: Uses flow cytometry to detect CD61 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 CD61.
Clinical Significance: Abnormal CD61 expression suggests platelet disorders, prompting treatment. Normal results may require additional testing.
Specialist Consultation: Consult a hematologist for result interpretation.
Additional Supporting Tests: Platelet function tests, other flow cytometry markers, or coagulation studies to confirm platelet disorders.
Test Limitations: Non-specific expression may occur in non-malignant conditions. Results require clinical correlation.
References: ASH Platelet Guidelines, 2023; Blood, George JN, 2022.
