# Development of an ELISA for serosurveillance of human hookworm

> **NIH NIH R43** · KEPHERA DIAGNOSTICS, LLC · 2024 · $300,000

## Abstract

Hookworm infection, caused by Necator americanus, Ancylostoma duodenale, and Ancylostoma ceylanicum is
a leading cause of malnutrition and stunted growth in poor communities across sub-Saharan Africa, Asia, and
parts of South America. Recent studies have revealed the re-emergence of this parasite in the USA. The burden
of hookworm infection is generally associated with chronic illness rather than mortality in the host. Anemia,
stunted development, and intellectual and cognitive deficiencies are among the most serious outcomes of
persistent hookworm infections in children and women of reproductive age. In addition, chronic low-intensity
hookworm infection reduces vaccine efficacy and exacerbates other globally relevant infectious diseases such
as tuberculosis, malaria, and HIV, which are co-endemic with hookworm. Current strategies to control hookworm
rely primarily on the Mass Drug Administration of anthelminthic drugs. However, recent evidence calls into
question the long-term effectiveness of this approach to control and eliminate hookworm in endemic populations,
raising concern about the emergence of drug resistance. The current method to screen for STH infections is
microscopic demonstration and quantification of eggs in the stool. For screening, WHO considers the Kato-Katz
thick smear as a benchmark for diagnosing hookworm infection. This method, however, has poor sensitivity.
Processing multiple smears per sample or examining multiple samples over consecutive days can increase the
sensitivity of the Kato-Katz thick smear. While screening multiple samples improves sensitivity, it presents
considerable logistical and financial challenges and is not practical in all settings. To address this, WHO recently
published a Target Product Profile for soil-transmitted helminths to develop low-cost screening tools that meet
demands, currently not met by the Kato-Katz thick smear. To address this need, in Phase I we propose the
development of an ELISA to screen for human IgG against hookworm infection. In collaboration with Yale
University, we will perform a combination of in-silico and in-vitro studies, to help characterize biomarkers of
interest (Aim 1), which will be used in the development of an ELISA (Aim 2). We will then evaluate assay
performance (Aim 2) using well-characterized cohorts of serum samples. Our goal is to achieve sensitivity and
specificity as outlined in the TPP, with further improvement in Phase II. The proposed commercial ELISA kit will
allow for the replacement of the existing, relatively insensitive microscopic tools, to integrate as part of monitoring
and evaluation programs for hookworm infection around the world. This will directly impact future global policy
and strategy for the control of hookworm infection.

## Key facts

- **NIH application ID:** 10815737
- **Project number:** 5R43AI174487-02
- **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:** $300,000
- **Award type:** 5
- **Project period:** 2023-04-01 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10815737

## Citation

> US National Institutes of Health, RePORTER application 10815737, Development of an ELISA for serosurveillance of human hookworm (5R43AI174487-02). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10815737. Licensed CC0.

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