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 and the evidence is insufficient to determine the effects of the technology on health outcomes.
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. Medical Policy Reference Manual. (12:2017). Immune cell function assay (2.04.56). Retrieved June 28, 2018 from BlueWeb. (41 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.
Palmetto, GBA. (2018, May) Local Coverage Determination (LCD): Assays for vitamins and metabolic function (L33418). Retrieved June 28, 2018 from https://www.cms.gov.
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, August). 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. (2013). International consensus guidelines on the management of cytomegalovirus in solid organ transplantation. Retrieved June 23, 2017 from http://cdn.gnowee.net/cmv/guidelines.
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: 8/9/2018
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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