# Diagnostic assay for congenital Chagas disease

> **NIH NIH R43** · KEPHERA DIAGNOSTICS, LLC · 2024 · $303,250

## Abstract

Project Summary
This project aims to develop a diagnostic test for congenital Chagas disease (cCD), caused when infection with
the protozoan Trypanosoma cruzi is passed from mother to fetus during pregnancy. Chagas disease is the
parasitic disease with the highest burden in the Western hemisphere, yet the need remains for accurate and
accessible diagnostics. This is particularly true for congenital transmission of the infection, as treatment in infants
is much more effective and well-tolerated than in chronic adult infections. However, the current diagnostic
standard for infants with a risk of congenital Chagas remains microscopy, which is highly subjective and misses
a large percentage of infections, and IgG testing at 8-9 months after birth, which results in an enormous loss to
follow up. A diagnostic assay targeting anti-T. cruzi IgM would meet the need for an accurate and accessible
point-of-delivery test and enable cost-saving, widespread screening of newborns. Two versions of a test for cCD
based on IgM detection will be developed, the best performing of which will be advanced in Phase II: (1) an IgM
Western blot based on native Trypomastigote Excreted/Secreted Antigen (TESA) and (2) a peptide IgM ELISA
based on Shed Acute-Phase Antigen (SAPA). Both tests will address the need for batch-to-batch and laboratory-
to-laboratory consistency in antigens used and will produce a result in approximately three hours. Panels of well-
characterized congenital Chagas samples and controls, including cross-reactive samples from other parasitic
infections, will be used to optimize both versions of the test as well as determine initial sensitivity and specificity
of each assay format. One major hurdle to commercialization of Western blot-based methods is the difficulty in
interpreting test results. As it is widely recognized that mobile phone technology provides an opportunity to
address such diagnostic challenges, this technology will be leveraged to standardize Western blot interpretation
through development of a prototype smartphone application that can perform automated blot analysis. A
machine-learning algorithm will be implemented for this purpose to interpret IgM Western blot band patterns,
removing the need for subjective human interpretation. The successful completion of Phase I objectives will
demonstrate the feasibility of an IgM diagnostic test for congenital Chagas disease which can be scaled to
manufacturing in Phase II and will address a recognized global and public health priority.

## Key facts

- **NIH application ID:** 10921719
- **Project number:** 1R43AI181234-01A1
- **Recipient organization:** KEPHERA DIAGNOSTICS, LLC
- **Principal Investigator:** Andrew E. Levin
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $303,250
- **Award type:** 1
- **Project period:** 2024-05-01 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10921719

## Citation

> US National Institutes of Health, RePORTER application 10921719, Diagnostic assay for congenital Chagas disease (1R43AI181234-01A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10921719. Licensed CC0.

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