Rapid diagnostic immunoassay for strongyloidiasis

The National Institute of Allergy and Infectious Diseases awarded Kephera Diagnostics LLC $303,250 on August 24, 2026, under the Allergy and Infectious Diseases Research program (CFDA 93.855) to develop a rapid diagnostic immunoassay for strongyloidiasis caused by Strongyloides stercoralis.

The award funds Phase I research to identify novel and improved biomarkers for detecting strongyloidiasis through in-silico and high-throughput screening to map immunodominant epitopes. The work addresses diagnostic gaps in current methods: microscopic examination of stool samples lacks sensitivity in chronic and low-intensity infections, and existing serological tests exhibit poor sensitivity and specificity, leading to underdiagnosis. Strongyloidiasis presents particular clinical urgency because the parasite's auto-infective lifecycle enables chronic and potentially lifelong infection, with hyperinfection syndrome causing high mortality rates in immunocompromised individuals. The World Health Organization has emphasized the need for improved diagnostic approaches.

Kephera Diagnostics, a for-profit limited liability company headquartered in Framingham, Massachusetts, specializes in developing diagnostic solutions for infectious diseases and neglected tropical diseases. The period of performance runs through July 31, 2028, with work performed at the company's Framingham location.

Abstract

Strongyloidiasis, caused by the parasitic nematode strongyloides stercoralis, poses a significant public health challenge in various regions, particularly in tropical and subtropical areas. While traditionally considered endemic in these regions, recent evidence has highlighted the RE-emergence of strongyloides infection in non-endemic areas, including the united states. Unlike some other soil-transmitted helminths (STH), strongyloides due to its auto-infective lifecycle, is unique in its ability to establish a chronic and potentially life-long infection in the host. Persistent infection with strongyloides can lead to various health complications, such as gastrointestinal symptoms, respiratory issues, and skin manifestations. The most severe form of the disease, hyperinfection syndrome, is associated with high mortality rates, especially in immunocompromised individuals and those under immunosuppressive treatments. The conventional method for diagnosing strongyloidiasis involves microscopic examination of stool samples, which may lack sensitivity, especially in chronic and low-intensity infections. Existing serological tests for strongyloidiasis exhibit poor performance, with inadequate sensitivity and specificity, leading to potential underdiagnosis and misclassification of cases. This inadequacy underscores the urgent need for improved diagnostic tools to enhance the accuracy of detecting strongyloides infections. The world health organization (who) acknowledges the challenges in the existing diagnostic approaches for strongyloides, emphasizing the need for improved and more reliable methods. Towards this end, in phase i, we propose identification of new and improved novel biomarkers (aim 1) by harnessing a comprehensive approach, involving in-silico and high throughput screening to map immunodominant epitopes. The shortlisted biomarkers of interest will undergo further screening that will be used in the development of both an elisa (aim 2) and point- of-care lateral flow (LF) rapid test (aim 3). Through the subsequent development and evaluation (aim 4) of the elisa and LF assays, we seek to achieve superior sensitivity and specificity targets, using well characterized serum samples obtained from strongyloidiasis patients confirmed using both stool examination and serology. The successful implementation of these serological tests will have a direct impact by contributing to the reduction of morbidity associated with chronic infections and enhancing the overall effectiveness of public health interventions.