An Integrated Microbasophil Activation Test for Accurate, Safe, and Accessible Food Allergy Diagnostics
Abstract
Food allergy has reached epidemic proportions. The increasing prevalence of food allergy has become a serious public health concern. Every immunoglobulin E (IgE)-mediated food allergy has the potential to be life-threatening, and allergic reactions due to accidental ingestions are common. Of relevance to the military, a diagnosis of food allergy has adverse effects on military personnel affecting their ability to join. Such allergies can also first develop in active duty personnel. Nevertheless, current food allergy tests are inadequate. The gold standard for food allergy assessment is an oral food challenge (OFC). It is often not performed as it places the patient at risk of anaphylaxis, which can be life-threatening. It requires supervision by specialized allergists and is both time- and resource-intensive. The accessibility of OFC is therefore severely limited in areas lacking such specialists and resources. Other conventional food allergy tests, such as skin prick tests and serum IgE, are safer and more accessible than OFC, but they do not always predict a true allergic reaction and have high false positive rates. As such, there is a critical unmet need for food allergy tests that are accurate and safe, and ideally, are also rapid and accessible to reduce the incidence of adverse reactions due to delayed diagnosis or misdiagnosis. Our goal is to address this unmet need by developing and validating a micro-basophil activation test (micro-BAT) for accurate, safe, and accessible food allergy diagnostics, and to validate, using the micro-BAT, basophil activation as a biomarker for predicting the severity of a food allergic reaction and the effectiveness of food allergy treatment. The envisioned product will be a standalone, fieldable, sample-in-answer-out machine, approximately the size of a desktop printer, that takes whole blood from a patient and returns the likelihood of a food allergy with high accuracy. We will achieve our goal using the world-class clinical research units at the Stanford Sean N. Parker Center for Allergy & Asthma Research, which is known for excellent recruitment and retention of patient cohorts, and state-of-the-art research at the Stanford School of Engineering and the School of Medicine. We will optimize and characterize the integrated micro-BAT instrument, and validate its ability to predict a clinical food allergic reaction. Furthermore, we will demonstrate micro-BAT’s added utility in requiring small volumes of blood potentially from a finger prick, and increased sensitivity when the test is performed immediately after blood draw which can leverage the fieldable form factor of the instrument. Finally, we will demonstrate the utility of our instrument for additional foods. The key strengths of our proposal are that our approach is supported by substantial preliminary data demonstrating feasibility, leveraging years of scientific research performed by the investigators. Our multidisciplinary team, combining clinical, laboratory testing, and engineering expertise, has a track record of successful recruitment and retention of food allergic patients, rigorous clinical validation of allergy, and the development and validation of innovative diagnostic devices and biomarkers supported by rigorous statistical analysis. Our project directly addresses Peer Reviewed Medical Research Program Portfolio of Autoimmune Disorders and Immunology, fiscal year 2022 (FY22) PRMRP Topic Area of Food Allergies, and the FY22 PRMRP Strategic Goal of Diagnosis - Identify biomarkers to predict onset and/or progression of associated immune-mediated diseases, by identifying and validating basophil activation, using the micro-BAT, as a biomarker to predict the allergic status, the severity of an allergic reaction, and the effectiveness of treatment of potentially fatal food allergy, which is an immune-mediated disease. If successful, we envision that the micro-BAT will complement or eve
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252311048
Entities
People
- Sindy K Y Tang
Organizations
- Stanford University
- United States Army