Table. Interpretation of Assay Results
ATP Range Immune Response
|CPT Code||86352: Cellular function assay involving stimulation (e.g., mitogen or antigen) and detection of a biomarker
83912: Reporting & Interpretation
|Schedule Turnaround Time||Assay performed Monday through Thursday, Thursday cut-off time for receipt in lab is 3:00pm, Not on Fridays,. Report availability is within 48 hours from the time of specimen receipt
|Specimen Requirements||1-3mL whole blood collected in sterile sodium heparin green-top tube. DO NOT USE lithium heparin, ACD tubes or EDTA anti-coagulants.
Specimen should be kept at ambient (Room) temperature ONLY (18–28°C) and should not be refrigerated or frozen.
Assay must be set up within 30 hours of specimen collection. Specimens received after 30 hours are not viable for testing.
|Clinical Relevance||In April 2002, the FDA cleared for marketing the Cylex Immune Cell Function Assay (Cylex Inc., Columbia, MD) for the detection of cell mediated immune response in populations undergoing immunosuppressive therapy for organ transplant.
Apart from transplant monitoring the assay could also be used in management of infectious diseases (e.g. HIV, HCV), autoimmunity, cancer, as well as vaccine and drug development. For blood marrow transplantation, the assay is reported to determine risks for GvHD and infection to aid physicians in tailoring GvHD and infection prophylaxis.
The assay detects intracellular ATP synthesis in stimulated CD4+ cells selected from whole blood by monoclonal antibody coated magnetic beads. The amount of ATP produced reflects global T cell function. The measurement of CD4+ activation reflects cellular immunity because the CD4+ lymphocytes orchestrate cell-mediated immunity through immunoregulatory signaling.