Celiac disease is an autoimmune condition where the body has a harmful reaction to gluten, a protein found in wheat, barley, and rye. When someone with celiac disease eats gluten, their immune system mistakenly attacks their small intestine, causing inflammation and damage to the delicate lining of the intestine. Over time, this damage makes it harder for the body to absorb important nutrients from food, which can lead to malnutrition, weight loss, and a range of other health problems.

The symptoms of celiac disease can vary widely, and they don't always show up immediately. Some people may experience digestive issues like bloating, diarrhea, or stomach pain, while others might have symptoms outside of the gut, like fatigue, joint pain, or even skin rashes. In children, it can also affect growth and development.

The only treatment for celiac disease is a strict, lifelong gluten-free diet. This means avoiding foods and drinks that contain wheat, barley, and rye, which can be tough, especially since gluten is hidden in so many everyday products. But sticking to a gluten-free diet can help manage the symptoms, promote healing in the intestine, and prevent further damage.

It is crucial for individuals with celiac disease to be diagnosed as early on as possible due to the damage the condition caused to the small intestine if left undetected. Celiac disease may prove to be most harmful to young children and adolescents who are still growing and physically developing. Individuals with damaged villi in their small intestines are unable to extract the necessary nutrients from the food they consume and are therefore, unable to provide their bodies with the proper nutrition needed for healthy body function. The absorption of ingredients is crucial for young children and their development through their early years and adolescence. Children with undiagnosed celiac disease suffer from intestinal damage which hinders the performance of their immune system and negatively affects their growth. Some common hindrances in the growth of children diagnosed with celiac disease include lower bone density, iron deficiency/anemia, weight loss, and even delayed onset of puberty. 

Given the gravity of negative effects of undiagnosed celiac disease on individuals, particularly children, I recognize that it is crucial for celiac disease to be diagnosed as early on in an individual's life as possible. To contribute to mitigating the delayed diagnosis of celiac disease around the world, I have designed a comprehensive multifaceted immunoassay aimed at detecting celiac disease in a variety of patients, including those displaying regular antibodies to celiac disease, those with antibody deficiencies, and those with hidden celiac disease due to seronegative results. My immunoassay aims to detect strong evidence of celiac disease with high sensitivity and specificity, allowing medical practitioners to send patients for further testing much sooner. Currently, the process to diagnose celiac disease is quite lengthy, requiring multiple blood work appointments, sending patients for invasive medical procedures, and multiple visits with gastroenterology experts. This time-consuming method of diagnosis leaves individuals at risk of further intestinal damage as patients are required to continue a gluten-based diet during the entire testing and diagnosis period. My project aims to accelerate diagnosis for celiac disease, overall mitigating intestinal damage for celiac patients and therefore, allowing patients to take charge of their bodies and improve their health earlier on.

The aim of this project is to innovate an immunoassay to detect signs of celiac disease on the basis of researched techniques and data I’ve tested (docking and affinity). 

• Research → I researched multiple aspects of celiac disease from causes to detection to the damage caused by innate and adaptive immune response. The focus of the research was primarily on types of immunoassays and specific biomarkers involved in celiac disease.
• Identifying antibody targets & antigens → I researched further into specific antibodies and antigens for celiac disease, organizing them under “Target” and “Antigen” categories. I also created a biomarkers reference sheet for all celiac disease biomarkers pertaining to my research.
• Selecting assay format → I selected an assay format prioritizing the specificity and accuracy provided by each test. Multiple considerations, including various data outlined in research, were considered when selecting an assay format.
• Selecting antibodies → I selected antibodies for use in my immunoassay on the basis of high specificity and sensitivity to antigens. I also accounted for other factors such as certain deficiencies and borderline results to create an immunoassay for an inclusive group with potential celiac pathogenicity. 
• Select sample types (e.g. blood, plasma, serum) → I selected a sample type which users will conveniently be able to provide for clinical testing. When selecting a sample type, concentrations of antibodies and antigens present in the sample were also considered. 
• Enhancements → I added additional methods to optimize the performance of my immunoassay. These methods included adding a blocking agent to improve binding and limit non-specific binding, and controlling temperature and pH for optimal binding. 
• Testing sensitivity and specificity → Theoretical sensitivity and specificity was tested for my immunoassay through docking simulations I had run.
• Review guidelines for celiac disease diagnosis by government/medical platforms → I reviewed diagnosis standards for different antibodies to set/determine appropriate cutoff values for my immunoassay.
• Evaluating cost, scalability, production → I contacted various immunoassay companies to get a quote on prices for creating an immunoassay.
• Addressing the impact of a gluten-free diet on assay performance → I addressed the impact a gluten-free diet would have on the performance and the accuracy of the immunoassay that I have designed.

Testing my immunoassay has taken longer than anticipated, so I am unable to present any results at the moment. Results from testing will be presented at the city science fair.

Testing my immunoassay has taken longer than anticipated, so I am unable to present any results at the moment. Results from testing will be presented at the city science fair.

Antibodies in celiac disease: implications beyond diagnostics. (n.d.). PubMed Central. Retrieved March 8, 2025, from https://pmc.ncbi.nlm.nih.gov/articles/PMC4003135/

Back to Basics: What is an Immunoassay? (2016, July 16). Antibiotics Inc. Retrieved March 8, 2025, from https://www.antibodiesinc.com/blogs/news/back-basics-immunoassay?

Caio, G., & Volta, U. (2019, July 23). Celiac disease: a comprehensive current review - BMC Medicine. BMC Medicine. Retrieved March 8, 2025, from https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-019-1380-z

Celiac disease - Diagnosis and treatment. (2023, September 12). Mayo Clinic. Retrieved March 8, 2025, from https://www.mayoclinic.org/diseases-conditions/celiac-disease/diagnosis-treatment/drc-20352225

Celiac Disease Screening. (n.d.). Celiac Disease Foundation. Retrieved March 8, 2025, from https://celiac.org/about-celiac-disease/screening-and-diagnosis/screening/

Celiac Disease: Symptoms & How It's Treated. (n.d.). Cleveland Clinic. Retrieved March 8, 2025, from https://my.clevelandclinic.org/health/diseases/14240-celiac-disease

Ciccocioppo, R., Sabatino, A. D., & Corazza, G. R. (2005, June). The Immune Recognition of Gluten in Coeliac Disease. National Library of Medicine. Retrieved March 8, 2005, from https://pmc.ncbi.nlm.nih.gov/articles/PMC1809391/

Darwish, I. A. (n.d.). Immunoassay Methods and their Applications in Pharmaceutical Analysis: Basic Methodology and Recent Advances. PubMed Central. Retrieved March 8, 2025, from https://pmc.ncbi.nlm.nih.gov/articles/PMC3614608/

Guide to Immunoassays. (n.d.). Promega Corporation. Retrieved March 8, 2025, from https://www.promega.ca/resources/pubhub/immunoassay-guide/

Koning, F. (2005, October). Celiac Disease: Caught Between a Rock and a Hard Place. Science Direct. Retrieved March 8, 2005, from https://www.sciencedirect.com/science/article/abs/pii/S0016508505014307

Monoclonal and Polyclonal Antibodies. (n.d.). Assay Genie. Retrieved March 8, 2025, from https://www.assaygenie.com/blog/monoclonal-and-polyclonal-antibodies#:~:text=Monoclonal%20antibodies%20are%20highly%20specific,versatility%20in%20various%20research%20applications.
 

I'd like to thank my science fair coordinator, Mr. Buhler, for the opportunity to participate in the science fair and for his support in conducting regular meetings to ensure the completion of my project. I'd also like to acknowledge him reaching out to experts at the University of Calgary, allowing me to seek answers to all of my questions regarding my project. 

I'd also like to acknowledge and thank Katherine Buhler for her presentation and advice on creating effective scientific posters and displays.

Finally, I'd like to thank my parents for their financial support for my project.