Immune Cell Function Assay
The immune cell function assay measures the concentration of adenosine triphosphate (ATP) in whole blood and has been proposed as a method to monitor immunosuppression parameters in individuals with solid organ and hematopoietic stem cell transplants. Careful monitoring of lifelong immunosuppression is required to balance the dual risks of rejection and infection. Currently, immunosuppression levels are determined by testing for clinical toxicity (e.g., leukopenia, renal failure) and by therapeutic drug monitoring.
Immune cell function assays (i.e., ImmuKnow®, Pleximmune™) have been cleared for marketing by the FDA; however, the predictive characteristics of the test are still uncertain.
Immune cell function assay for all conditions/diseases including, but not limited to, the following is considered investigational:
To monitor and/or predict immune function after solid organ transplant
To monitor and/or predict immune function after hematopoietic stem cell transplantation
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The clinical utility of immune cell function assays to impact net health outcome in comparison to current methods of care for transplant recipients has not been evaluated.
BlueCross BlueShield Association. Evidence Positioning System. (1:2021). Immune cell function assay (2.04.56). Retrieved February 12, 2021 from https://www.evidencepositioningsystem.com/. (39 articles and/or guidelines reviewed)
Ling, X., Xiong, J., Liang, W., Schroder, P., Wu, L., Ju, W., et al. (2012). Can immune cell function assay identify patients at risk of infection or rejection? A meta-analysis. Transplantation, 93 (7), 737-743. Abstract retrieved June 23, 2017 from PubMed database.
Qu, W., Zhu, Z., Sun, L., Wei, L., Liu, Y. & Zeng, Z. (2017). Correlation between survival interval and CD4+ t-Cell intracellular ATP levels in liver transplant recipients. Transplantation Proceedings, 49 (2), 316-321. Abstract retrieved June 23, 2017 from PubMed database.
Ravaioli, M., Neri, F., Lazzarotto, T., Bertuzzo, V., Di Gioia, P., Stacchine, G., et al. (2015). Immunosuppression modifications based on an immune response assay: results of a randomized, controlled trial. Transplantation, 99 (8), 1625-1632. Abstract retrieved August 1, 2016 from PubMed database.
Rodrigo, E., Lόpez-Hoyos, M., Corral, M., Fábrega, E., Fernández-Fresnedo, G., San Segundo, D., et al. (2012). ImmuKnow as a diagnostic tool for predicting infection and acute rejection in adult liver transplant recipients: a systematic review and meta-analysis. Liver Transplantation, 18, 1245-1253. (Level 2 evidence)
Takahashi, M., Ohsumi, A., Ohata, K., Kondo, T., Motoyama, H., Hijiya, K., et al. (2017). Immune function monitoring in lung transplantation using adenosine triphosphate production: time trends and relationship to postoperative infection. Surgery Today, 47 (6), 762-769. Abstract retrieved June 23, 2017 from PubMed database.
Transplantation Society International CMV Consensus Group. (2018). The third international consensus guidelines on the management of cytomegalovirus in solid organ transplantation. Retrieved June 18, 2019 from https://journals.lww.com/transplantjournal/fulltext/2018/06000/The_Third_International_Consensus_Guidelines_on.13.aspx#pdf-link.
U. S. Food and Drug Administration. (2005. September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K101911. Retrieved January 20, 2012 from http://www.accessdata.fda.gov.
U.S. Food and Drug Administration. (2014, August). Humanitarian Use Devices and Humanitarian Device Exemption. Retrieved June 23, 2017 from https://www.fda.gov.
ORIGINAL EFFECTIVE DATE: 6/9/2012
MOST RECENT REVIEW DATE: 4/8/2021
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