CHAGAS DISEASE SEROLOGY ANTIGEN

Researchers at CZ Biohub SF and UCSF have developed a novel diagnostic application for Chagas disease using a selective antigen.

Chagas disease is an infection caused by the parasite Trypanosoma cruzi (T. cruzi). This disease is primarily endemic to Latin America but increasingly recognized in the United States, particularly among Latinx immigrant populations. Chagas disease can persist chronically and asymptomatically for decades, during which the parasite resides intracellularly, ultimately leading to irreversible cardiac and gastrointestinal damage. Serological detection of anti-T. cruzi antibodies remains the most sensitive diagnostic method during the chronic phase; however, due to the suboptimal accuracy of existing commercial assays and the low disease prevalence, diagnosis typically requires confirmation through two independent tests. Accurate detection is critical not only for clinical diagnosis but also for screening blood donors and evaluating transplant recipients and donors. Advancements in serological diagnostics for T. cruzi could significantly enhance patient outcomes and bolster safety across multiple sectors of the healthcare system.

Stage of Research

The inventors have developed a novel diagnostic for Chagas disease. This innovative technology offers a powerful and reliable method for detecting Trypanosoma cruzi, the parasite responsible for Chagas disease, using uniquely engineered polypeptides that target highly specific antibody responses. By incorporating proprietary epitope sequences, these peptides enable sensitive and accurate identification of infection through a variety of diagnostic formats, including ELISA, lateral flow assays, and Western blotting. The method is adaptable to blood, tissue, or other biological samples, making it ideal for clinical diagnostics, blood donor screening, and transplant safety. Furthermore, the technology supports seamless integration into existing laboratory workflows and point-of-care settings, enhancing early detection and enabling timely treatment with antiparasitic drugs. This breakthrough solution elevates the standard for Chagas disease diagnostics and offers tremendous value across healthcare and public health applications.

Applications

• Clinical Diagnostics- Enables accurate and early detection of Trypanosoma cruzi infection in patients, including those in the chronic phase when traditional methods may fail.
• Blood Donor Screening- Ensures the safety of the blood supply by identifying infected donors, preventing transfusion-transmitted Chagas disease.
• Transplant Screening- Provides a critical tool for screening organ and stem cell donors and recipients, reducing the risk of disease transmission during transplantation procedures.

Advantages

• Enhanced Diagnostic Accuracy - The use of specific polypeptide epitopes significantly improves sensitivity and specificity for detecting T. cruzi-specific antibodies, reducing false positives and negatives. 
• Versatile Integration Across Platforms - The invention is compatible with multiple assay formats such as ELISA, lateral flow, and chemiluminescence, making it adaptable for clinical labs, point-of-care testing, and high-throughput screening.

Stage of Development

Research- in vitro

Keywords

Antigen, Diagnosis, Pathogen

Technology Reference

CZ Biohub ref. no. CZB-315F

UCSF ref. no. SF2025-004