The information contained on these Web pages for Center for Environmental Medicine is based on research and years of collective clinical experience by its medical team members. This communication is current at the time of posting and is published as a courtesy to the public for informational purposes only. This information is not intended to be a basis for diagnosis or treatment nor a substitute for evaluation and treatment by a competent, licensed, healthcare professional. We do not recommend changes or additions to any current medications or therapies without personally consulting a qualified physician educated in these matters. Varying and even conflicting views are held by other segments of the medical profession. Center for Environmental Medicine and its staff members specifically disclaim any liability arising directly or indirectly from information contained on these Web pages.
US Biotek Disclaimer
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US BioTek has developed and determined the performance characteristics of its assays. These in-house assays have not been cleared or approved by the U.S. Food and Drug Administration (“FDA”) and are considered for investigational and research purposes only. The FDA does not require these types of in-house testing to go through pre-market FDA review.
Quantification of specific IgE antibodies to foods and inhalants is an FDA-accepted diagnostic procedure for the assessment of allergies. However, the assessment of human IgG or IgA antibodies specific for individual food and inhalent antigens is not an FDA-recognized diagnostic indicator of allergy. While still primarily a research and investigation tool, specific IgG quantification has been utilized in research settings to assess and investigate Type I and Type III allergies, respectively. The FDA considers IgG or IgA testing to be of an investigational or research nature and does not consider clinical data to be conclusive for the use of such testing in the diagnosis of food allergies.
US BioTek makes no claims as to the diagnostic or therapeutic use of its tests or other informational materials. US BioTek is not responsible or liable for misuse or misinterpretation of the information provided, or any diagnoses or healthcare changes initiated by a patient or a healthcare practitioner based on the content of US BioTek’s informational materials.
Not all insurers may provide coverage for these tests
