Development of a sensitive and specific point-of-care diagnostics for Asian zoonotic schistosomiasis
Project Completed
 
  • Awarded Year
    2014
  • Awarded Amount
    $779,036
  • Disease
    NTDs Schistosomiasis
  • Intervention
    Diagnostics
  • Development Stage
    Product Design
  • Collaboration Partners
    Graduate School of Agricultural and Life Sciences, The University of Tokyo, InBios International, Inc., University of the Philippines, National Research Center for Protozoan Diseases, Obihiro University of Agriculture and Veterinary Medicine

Introduction and Background of the Project

Asian zoonotic schistosomiasis is a parasitic disease caused by the blood fluke Schistosoma japonicum. This parasite infects humans through contact with contaminated water making children and farmers at high risk of infection. The disease is endemic in China, the Philippines and parts of Indonesia. Fifty million people in China and 2.5 million people in the Philippines are at risk of having the infection. Vaccine has not been developed so the disease control solely relies on chemotherapy with mass drug administration (MDA) of praziquantel in endemic areas. The London Declaration in 2012 also encouraged this strategy to be developed in the disease endemic countries. Follow-up assessment of the effectiveness of the disease control depends entirely on labor-intensive, time-consuming and low sensitive microscopic examination of stool for the detection of the parasite eggs. A rapid point-of-care test (POCT) with higher sensitivity will therefore improve the efficacy of the follow-up program of MDA and will facilitate morbidity control. Also, POCT will be applicable in active case detection and confirmatory diagnosis with clinically suspected patients.

 

The National Research Center for Protozoan Diseases (NRCPD), Obihiro University has already identified the recombinant thioredoxin peroxidase-1 (SjTPx-1) and the tandem repeat Sj7TR proteins as good diagnostic antigens for human schistosomiasis. Additional targets complementing the said recombinant antigens will be screened and selected to increase the sensitivity of the test. These recombinant antigens will be applied as diagnostic antigens for an antibody detection-based POCT.

How can your partnership (project) address global health challenges?

The World Health Organization targets the elimination of schistosomiasis by 2020. As the number of cases in endemic areas has declined significantly due to MDA, the real challenge now is to develop an effective surveillance system that can detect the disease in different diagnostic settings. This project aims to produce the POCT that will be user-friendly, feasible to use in remote areas and replace the traditional microscopic examination in schistosomiasis diagnosis.

 

Our approach to such a POCT is to develop an antibody detection test using defined antigens, and expertise of all the collaboration partners is essential in achieving the goal. NRCPD is well equipped in leading this project in developing POCT for human schistosomiasis as it is a foremost institution in developing diagnostic techniques for different parasitic diseases with veterinary importance. Graduate School of Agriculture and Life Sciences, the University of Tokyo has an excellent expertise in antigen discovery, and is a pioneer of in silico antigen discovery for parasitic diseases. The College of Public Health, the University of the Philippines Manila is the premiere public health education institution in the Philippines and expert in conducting researches on tropical medicine in the field. InBios International, Inc. is a medical diagnostic company that specializes in developing, manufacturing and marketing medical diagnostic tests for the detection of infectious diseases, and has developed proprietary technologies useful in the development of rapid and ELISA based immunodiagnostic assays. The company also has regulatory experience and has several FDA cleared products (http://www.inbios.com). Therefore, this partnership will make possible the development of a POCT for Asian zoonotic schistosomiasis.

What sort of innovation are you bringing in your project?

The Schistosomiasis Detect consortium will use its expertise in developing a highly sensitive and specific POCT that is designed to improve the current surveillance system for schistosomiasis. This is the first time that POCT using recombinant proteins for schistosomiasis will be developed. Previously developed lateral flow based diagnostic kits were utilizing the crude egg antigens which causes cross-reactions with other parasitic diseases affecting their specificity. This project takes advantage of our expertise in antigen discovery through systematic screening of parasite database. We have already succeeded in identifying parasite-specific antigens with diagnostic potential including Sj7TR through a computational analysis of the S. japonicum genome database, and will utilize this strategy to further our antigen discovery for development of an accurate POCT for schistosomiasis.

Role and Responsibility of Each Partner

The National Research Center for Protozoan Diseases (NRCPD) is a national research institute for different parasitic diseases and has been assigned as one of OIE collaborating Center. Dr. Shin-ichiro Kawazu’s group is currently working with the development of diagnostic tests for zoonotic schistosomiasis in both humans and animals. The NRCPD is the project’s lead agency responsible for the coordination between the collaborating partners. They are also serving as the main hub of experimental procedures in this project including the evaluation of the recombinant antigens, fusion proteins and the POCT module prototype.

 

The University of Tokyo The University of Tokyo (UT) is one of the top universities in Japan and Dr. Yasuyuki Goto’s laboratory in this university is well equipped to achieve discovery of novel diagnostic candidates for schistosomiasis. Dr. Goto has an excellent expertise in antigen discovery, and is a pioneer of in silico antigen discovery for parasitic diseases. He has established antigen mining based on tandem repeat which is so far successful to identify antigens with serological significance for leishmaniasis, Chagas disease, sleeping sickness as well as schistosomiasis. UT is responsible for this project’s antigen mining and development of chimeric proteins.

 

The College of Public Health (CPH) of the University of the Philippines Manila is the premier college of public health in the Philippines with Dr. Lydia R. Leonardo being a leading researcher for schistosomiasis in the Philippines. They have been involved in various researches on schistosomiasis that required both laboratory and field work. Since CPH is responsible for the coordination of the sampling sites and sample collection in the Philippines, their intensive and long-rooted collaboration with the Philippine Department of Health is important in the mobilization of health personnel necessary for this project’s field work.

 

InBios International is a twenty-year-old company specialized in developing, manufacturing and marketing medical diagnostic tests for the detection of infectious diseases based on the proprietary reagents and technologies. InBios is committed to developing high quality, cost effective diagnostics tests for neglected tropical diseases like Chagas’ disease and visceral leishmaniasis, cutaneous leishmaniasis and schistosomiasis. The company's facility is cGMP-compliant and FDA-registered, which enable to manufacture products in accordance with the Quality System Regulations of the FDA. In this project, InBios is responsible for developing the POCT module prototype for the detection of schistosomiasis in humans.

Others (including references if necessary)

1. World Health Organization, 2012. Accelerating work to overcome the global impact of neglected tropical diseases; a roadmap for implementation. Geneva, 2012

2. London Declaration on Neglected Tropical Diseases, www.UnitingToCombatNTDs.org

3. Angeles JM, Goto Y, Kirinoki M, Leonardo L, Tongol-Rivera P, Villacorte E, Inoue N, Chigusa Y, Kawazu S. Human antibody response to thioredoxin peroxidase-1 and tandem repeat proteins as immunodiagnostic antigen candidates for Schistosoma japonicum infection. American Journal of Tropical Medicine and Hygiene 2011, 85(4):674–679.