|
Disclaimer
US BioTek has developed and determined the performance characteristics
of its assays excluding the Adrenal Hormone Panel. 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 this type
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 antibodies specific for individual
food 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 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’s
test results and other information do not constitute medical advice,
are provided for educational purposes only, and are not a substitute
for professional medical advice. 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. Please consult your healthcare provider for questions
regarding test results, or before beginning any course of supplementation
or dietary changes.
Not all insurers may provide coverage for these
tests.
Back to Top
|
