The leukocyte histamine release test (LHRT) measures the amount of histamine released in-vitro. An allergen extract in varying concentrations is added to the peripheral blood leukocytes of the individual being tested and the in vitro release of histamine from basophils in response to exposure to the allergen is measured. Histamine is normally released as a consequence of the interaction of allergen with cell-bound IgE antibodies. If an individual is hypersensitive to a specific antigen, the leukocytes will release the histamine in-vitro. Only a limited number of allergens can be tested from a single sample of blood. Quality control studies have shown variability in the measurement of histamine results.
The leukocyte histamine release test in the diagnosis of allergies is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
The leukocyte histamine release test is primarily used in the research setting. Clinical data supporting its role in the clinical setting is lacking.
Annals of Allergy, Asthma, & Immunology. (2008, March). Allergy diagnostic testing: an updated practice parameter. Retrieved October 17, 2016 from https://www.aaaai.org.
Auslander, D., Eggerschwiler, B., Kemmer, C., Geering, B., Auslander, S., & Fussenegger, M. (2014). A designer cell-based histamine-specific human allergy profiler. Nature Communications, 2014. (Level 4 evidence)
CMS.gov: Centers for Medicare & Medicaid Services. Palmetto GBA. (2019, May). Noncovered services other than CPT category III noncovered services (LCD ID L36954). Retrieved July 1, 2019 from https://www.cms.gov.
Larsen, L.F., Juel-Berg, N., Hansen, K.S., Clare Mills, E.N., van Ree, R., Poulsen, L.K., & Jensen, B.M. (2018). A comparative study on basophil activation test, histamine release assay, and passive sensitization histamine release assay in the diagnosis of peanut allergy. Allergy, 73 (1), 137-144. Abstract retrieved August 7, 2018 from PubMed database.
Michalak, A., Lewandowska-Polak, A., Moskwa, S., Kowalski, M., & Grzegorczyk, J. (2015). IgE-mediated 15-hydroxyeicosatetraenoic acid (15-HETE) generation by peripheral blood leukocytes: its association with basophil activation. Advances in Dermatology and Allergology, 32 (4), 262-267. (Level 4 evidence)
ORIGINAL EFFECTIVE DATE: 10/12/1998
MOST RECENT REVIEW DATE: 9/26/2019
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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