Facile Detection of Soil-Transmitted Helminth Infections

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43AI085744-01A1
Agency Tracking Number: AI085744
Amount: $600,000.00
Phase: Phase I
Program: SBIR
Awards Year: 2010
Solicitation Year: 2010
Solicitation Topic Code: NIAID
Solicitation Number: PHS2010-2
Small Business Information
DIVERGENCE, INC.
1005 NORTH WARSON ROAD, SUITE 401, SAINT LOUIS, MO, -
DUNS: 072669828
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 MICHAEL CRAWFORD
 (314) 812-8087
 CRAWFORD@DIVERGENCE.COM
Business Contact
Phone: (314) 812-8024
Email: insco@divergence.com
Research Institution
N/A
Abstract
DESCRIPTION (provided by applicant): The goal of this project is to develop a rapid and accurate immunodiagnostic test for detection of soil- transmitted helminths (STHs) that can be used without laboratory infrastructure. Human STH infections from whipworm (Trichuris), roundworm (Ascaris), and hookworms (Necator and Ancylostoma) create a substantial burden to worldwide public health. Current infection rates are staggering, with well over one billion people estimated to be harboring at least one of these nematode parasites, causing substantial morbidity. The current global strategy to control STH infections involves mass drug administration (MDA) of anthelmintic medicines without prior diagnosis. However, cure is often not complete and the limited number of available drugs has fueled concerns of parasite resistance. To support this drug administration strategy, clinical research activities have concurrently intensified. These include monitoring for the emergence of drug resistance and the effects of worm infection on childhood growth and development. Despite these needs, no commercial product to detect these parasites is available. All current diagnostic methods require the use of laboratory equipment and clinically trained personnel to identify parasitic species. The most widely-used method is the microscopic detection of parasite eggs, a labor-intensive technique with inadequate sensitivity and specificity. Therefore a rapid, sensitive, specific, and inexpensive method to detect parasitic worm infections without laboratory infrastructure or trained personnel would offer enormous advantages over current methods. Building upon extensive proof-of-concept data with closely related parasites, this proposal aims to develop an immunodiagnostic assay for detection of human STHs. The first step toward feasibility will involve cloning, recombinant expression, and generation of antiserum to select helminth targets, followed by ELISA and western analyses with parasite extracts and clinical samples (Phase I). Once targets providing adequate sensitivity and specificity are validated, further assay optimization, expansion of reagents, and evaluation of multiple epidemiologic settings will commence (Phase II). PUBLIC HEALTH RELEVANCE: Soil-transmitted helminths (STHs, roundworms) currently infect over one billion people globally, causing substantial morbidity and economic loss. The current microscopic method for detecting these parasites is time-consuming, requires laboratory infrastructure, and suffers from poor sensitivity. The goal of this project is to develop a rapid and accurate immunodiagnostic test for STH infections in support of patient management, epidemiologic studies, and surveillance of mass drug administration programs.

* information listed above is at the time of submission.

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