In Vitro Particle Size Measurement for Screening Hypersensitivity Reactions to Foods and Chemicals
DESCRIPTION
In vitro particle size measurement for screening hypersensitivity reactions (e.g., Mediator Release Test® or MRT®) involves the measurement of the aggregate release of inflammatory mediators from an individual's immunocytes after exposure to various food extracts and chemicals (e.g., food additives). A determination is made of the difference in volume of circulating immunocytes and plasma before and after an in vitro antigen challenge. For the Mediator Release Test®, portions of an individual's blood sample are incubated with various food extracts and food additives (typically 150 different substances). The degree of reactivity is determined by the degree of mediator release from the cells. A response, change in cellular and plasma volume, is thought to indicate a hypersensitivity reaction and results are used as a basis for modifying an individuals diet. The MRT® is one component of the Lifestyle Eating and Performance (LEAP®) Program of oligoantigenic dieting. This type of testing has been promoted for individuals with, among other conditions, irritable bowel syndrome, chronic fatigue syndrome, migraine headaches, and dermatologic conditions (e.g., eczema, dermatitis).
POLICY
In vitro particle size measurement for the purpose of screening hypersensitivity reactions to foods and chemicals is considered investigational.
ADDITIONAL INFORMATION
At present, very few studies have been published involving the use of this test in screening for hypersensitivity reactions to foods (e.g., sensitivity to cow's milk) and chemicals. Randomized controlled trials are needed to determine the efficacy of this test and to substantiate any potential health benefits associated with its use in diet modification.
In vitro particle size measurement for screening hypersensitivity reactions to foods and chemicals does not meet the following technology evaluation criteria:
The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
The technology must improve the net health outcome.
The technology must be as beneficial as any established alternatives.
The improvement must be attainable outside the investigational settings.
SOURCES
Don Self & Associates, Inc. An integrated disease management program for irritable bowel syndrome: Taking the "irritable" out of irritable bowel syndrome. Retrieved October 1, 2003 from http://www.donself.com/LEAP/LEAP-doc.ppt.
Kaczmarski, M., Sawicka, E., & Werpachowska, I. (1997). The mediator release test (MRT): A new generation of testing for food sensitivities in children and adults. Przeglad Pediatryczny, Supplement 1, 61-65. Abstract retrieved October 9, 2003 from packet received from Signet Diagnostic Corporation.
Knutson, L., Hallgren, R., Ahrenstedt, O., Bengtsson, U., Lavo, B., Lennernas, H., & Wilhalmasson-Knutson, T. (1994). Segmental intestinal perfusion. A "new" technique for human studies. Lakartidningen, 91 (19), 1941-1946. Abstract retrieved October 10, 2003 from PubMed database.
Pasula, M. J., & Nowak, J. (1999, May). Particle size measurement in suspensions, part 1: A laboratory method for exploring food sensitivities in illness. American Clinical Laboratory, 18 (4), 16-18.
Pasula, M. J., & Nowak, J. (1999, October). Particle size measurement in suspensions, part 2: An in vitro procedure for screening adverse reactions to foods and chemicals. American Clinical Laboratory, 18 (4), 14-15.
Quackwatch: Your Guide to Health Fraud, Quackery and Intelligent Decisions. (2003, August). Allergies: Dubious diagnosis and treatment. Retrieved October 10, 2003 from http://www.quackwatch.org/01QuackeryRelatedTopics/Tests/allergytests.html.
Signet Diagnostic Corporation. Mediator Release Test and Lifestyle Eating and Performance (LEAP) information packet received from Signet Diagnostic Corporation on October 8, 2003.
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EFFECTIVE DATE |
8/10/2006 |
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