Issue Stories

Immune cell function assay

FDA cleared for use in organ transplant patients

 The recently cleared Immune Cell Function Assay allows more rapid assessment of a patient’s immune status at any point in time. Results are available within 24 hours, using a small sample of whole blood.
     The test has received clearance to measure the immune response of patients receiving immunosuppressant therapy for organ transplantation. The assay measures the concentration of ATP from circulating CD4+ cells, following in vitro stimulation with phytohemagglutinin (PHA), as an indicator of immune function. It is intended as a bio-assay for drug activity to be used as an adjunct to drug level monitoring post-transplantation along with other clinical indicators.
     The test is easy to perform and results are available in 24 hours rather than several days. The use of whole blood as the sample is considered beneficial because the most widely used immunosuppressive drugs are found in red cells, allowing the assay to more closely mimic the in vivo response of the patient to drug therapy.
     This technology has possible future application to measurement of immune activity in patients with AIDS, cancer, other infectious diseases and autoimmune disorders.
Cylex
www.cylex.net
Keywords: assay, immune function

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