This document addresses cellular function assays including the ImmuKnow^® assay (Viracor-IBT Laboratories, Inc., Lee’s Summit, MO), CU Index^® (Viracor-IBT Laboratories, Inc., Lee’s Summit, MO), Pleximark^™ (Plexision, Inc., Pittsburg, PA), Pleximmune^™ (Plexision, Inc., Pittsburg, PA) and CMV inSIGHT^™ T Cell Immunity Panel (Eurofins Viracor Inc., Lenexa, KS). Immune cell function assays have been developed for use in the detection of changes in cell mediated immunity (CMI) in individuals undergoing immunosuppressive therapy following solid organ transplant and individuals undergoing treatment for a variety of other conditions such as chronic urticaria, Lyme disease, autologous and allogeneic hematopoietic stem-cell transplant recipients, immunodeficiency disorders and immune-mediated diseases such as multiple sclerosis and rheumatoid arthritis (RA).

Position Statement

Investigational and Not Medically Necessary:

An immune cell function assay is considered investigational and not medically necessary for all indications including, but not limited to:

1. Management of solid organ transplant rejection in an individual undergoing immunosuppressive therapy;
2. Identification of risk for rejection prior to kidney or any other solid organ transplantation;
3. Management of autologous or allogeneic hematopoietic stem cell transplantation;
4. Management of immunodeficiency disorders including human immunodeficiency virus (HIV) and severe combined immunodeficiency disease (SCID) and immune mediated disorders including rheumatoid arthritis (RA) and multiple sclerosis;
5. Testing for urticaria;
6. Diagnosis and management of Lyme disease.