Overview: CD43 TestIntroduction: The CD43 Test tests CD43 expression to diagnose leukemias or lymphomas, helping identify abnormal immune cell activity that may cause fatigue or swollen lymph nodes. Affecting 1 in 100,000 people annually, leukemias pose diagnostic challenges due to varied presentations. Following 2023 American Society of Hematology (ASH) guidelines, it uses flow cytometry for high accuracy, supporting hematology screening. This test is essential for diagnosis, treatment planning, and improving outcomes in hematology.
Other Names: Leukosialin Test, CD43 Marker Assay.
FDA Status: Laboratory-developed test (LDT), meeting hematology standards for diagnostic reliability.
Historical Milestone: Immune marker testing began in the 1980s with research by Remold-O'Donnell, who identified CD43 in leukocytes. Flow cytometry advancements in the 2000s by BD Biosciences improved detection, surpassing earlier immunohistochemistry methods.
Purpose: Measures CD43 expression to diagnose leukemias or lymphomas, guides therapy, and evaluates patients with fatigue, aiming to improve survival.
Test Parameters: CD43 expression
Pretest Condition: No special preparation required. Collect whole blood or tissue. Report history of immune issues.
Specimen: Whole Blood (EDTA, 2-5 mL), Tissue (FFPE, 0.5-2 cma³); 4 mL whole blood in Na Heparin tube. Transport in a biohazard container.
Sample Stability at Room Temperature: 24 hours
Sample Stability at Refrigeration: 48 hours
Sample Stability at Frozen: Not recommended
Medical History: Document fatigue or swollen lymph nodes. Include current medications or cancer history.
Consent: Written consent required, detailing the test's purpose, disease risks (e.g., leukemia), and sample collection risks.
Procedural Considerations: Uses flow cytometry to measure CD43, requiring labs with flow cytometers. Results available in 1-2 days. Performed in labs with strict handling.
Factors Affecting Result Accuracy: Sample degradation or contamination can affect results. Medications may alter expression, requiring correlation.
Clinical Significance: Positive CD43 confirms leukemia or lymphoma, guiding therapy. Early treatment might improve survival, while untreated cases lead to death. Normal levels may require additional markers.
Specialist Consultation: Consult a hematologist for interpretation.
Additional Supporting Tests: Bone marrow biopsy, CD19 test, or genetic panel to confirm diagnosis.
Test Limitations: Specific to CD43; correlation with other markers needed. False negatives possible with sample issues.
References: ASH Guidelines, 2023; Blood, Remold-O'Donnell E, 2022.
