Antibody Assessment Panels
IgA Antibody Panels
US BioTek Laboratories IgG antibody assays are designed to measure all 4 subclasses (IgG1 through IgG4) and are reported as a total IgG value on a semi-quantitative scale for each antigen.
Note: Food-specific-IgA and IgG have been utilized in research settings as a tool for a guided elimination diet in patients with food-related complaints. However, the clinical relevance of food and inhalant-specific IgA and IgG is not established. IgA and IgG antibodies are indicators of antigen exposure and are not directly indicative of allergic disease. Test results must be evaluated by the healthcare practitioner who understands the limitations of these tests. To learn more, click on our Disclaimer link. Not all insurers may provide coverage for these tests.
US BioTek Laboratories 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 Laboratories makes no claims as to the diagnostic or therapeutic use of its tests or other informational materials. US BioTek Laboratories 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.
If you have any questions, please call us at 877.318.8728.