May be useful when evaluating patients for a rare primary immune deficiency called IPEX (immune dysregulation, polyendocrinopathy, enteropathy, X-linked), graft-vs-host disease in post-hematopoietic stem cell transplantation, some malignancies, or autoimmune diseases.
Quantitative Flow Cytometry
New York DOH Approval Status
Lavender (K2 EDTA) or Pink (K2 EDTA).
Transport 4 mL whole blood. (Min: 1 mL) Specimens must be analyzed within 48 hours of collection.
Clotted or hemolyzed specimens.
Ambient: Unacceptable; Refrigerated: 48 hours; Frozen: Unacceptable
|Available Separately||Components||Reference Interval (Adults 19 & older)|
|No||TREGS CD4+CD25+FOXP3+CD127- Percent||1.0-7.0 percent of CD4|
|No||TREGS CD4+CD25+FOXP3+CD127-||8-48 cells/µL|
Regulatory T cells (Tregs) suppress the immune response, predominately through the transcription factor FOXP3. The major Treg population is CD4+, CD25+, CD127- with expression of intracellular FOXP3. Decreased Tregs occur in autoimmune disorders including allergy and asthma. Low numbers or compromised function of Tregs are found in graft vs host disease following bone marrow transplantation. Increasing Tregs is a potential cell therapy and decreasing Tregs may enhance immune surveillance of cancer cells. Monitoring Tregs may reflect the mechanism of disease and can assess the efficacy of treatment.
Severe FOXP3 compromise identified by low or absent Tregs is characteristic of the IPEX syndrome, which stands for Immune dysregulation, Polyendocrinopathy, Enteropathy, and X-linked syndrome. However, some FOXP3 mutations may completely inhibit function, yet still allow detection of the intracellular protein by immunologic methods, so absent Tregs by flow cytometry is sufficient, but not necessary for diagnosis.
Please note, reference intervals were established using normal adult donors aged 19 years and older. Therefore, clinical correlation of the results in pediatric patients is recommended.
This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes
Analyte Specific Reagent (ASR)
Pediatric ranges were not established.
|Component Test Code*||Component Chart Name||LOINC|
|3002250||TREGS CD4+CD25+FoxP3+CD127- %|