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PARTNERSHIPS FOR ENHANCED ENGAGEMENT IN RESEARCH (PEER) HEALTH
Cycle 1

Development of an antigen-capture immunoassay for the rapid diagnosis of acute leptospirosis.


Leptospirosis (LPS) is a globally important zoonotic disease endemic in Southeast Asia, with human infection commonly reported throughout the region. It is classified as a neglected disease in Indonesia and has been an increasing public health issue in the country. A number of recent outbreaks of leptospirosis have occurred in several areas in Indonesia, with mortality rates as high as 35%. Diagnosis of leptospirosis is particularly difficult because its symptoms are so variable, ranging from a classical flu syndrome to Weil’s disease. In addition, the availability of specific tests, including bacteria isolation, DNA testing, and serology using the microagglutination test (MAT), still remains limited to the lack of sufficient highly specialized laboratories.

The goal of this PEER project was to develop a sensitive, noninvasive, and inexpensive immunoassay for point-of-care diagnosis of leptospirosis. significantly improving the rate of diagnosis as well as providing a better understanding of leptospirosis endemicity within Indonesia. The research had three components: (1) production of a library of monoclonal antibodies (mAbs) specific to LPS or other circulating antigens secreted or shed during infection for the development of a prototype antigen capture enzyme-linked immunosorbent assay (ELISA); (2) construction of prototype immunoassay for leptospirosis diagnosis; and (3) a prevalence survey of leptospirosis in endemic areas in Indonesia using the prototype.

Final Summary of Project Activities

Working in close collaboration with their U.S. partner at the University of Nevada, the PI and her colleagues developed a molecular examination protocol for leptospirosis and three mAbs candidates for the antigen-based lateral flow test prototypes. They tested their prototype against known false and positive samples and registered it for a patent. The PI’s lab has formed a memorandum of understanding with PT. Konimex (a pharmaceutical company) and the Ministry of Health to continue developing early detection of leptospirosis using various platforms.

One of the project's outputs was to help strengthen national efforts to confirm cases of severe leptospirosis. The PI’s lab shared the leptospirosis examination protocol and formed a national laboratory network for the detection of leptospirosis and other zoonoses. The development of an early and rapid detection tool for leptospirosis also shows promise for further development to be used in diagnosing other emerging diseases, including the Nipah virus.

The PI and her team received three additional grants to continue their work, including $85,000 from the World Health Organization on molecular epidemiology of rodent borne diseases. The PEER project research contributed to the PIs doctoral work at the University of Indonesia. She presented her findings at the International Leptospirosis Society (ILS) Meeting in New Zealand and published one paper listed below.


Publication

Farida Dwi Handayani, Rahmi Ayu Wijayaningih, Ristiyanto, Muhammad Hussein Gasem, and Tri Wibawa. 2020. Comparison of DNA extraction methods for molecular identification of pathogenic Leptospira in the urine samples. Health Science Journal of Indonesia 11(2): 77-84. https://doi.org/10.22435/hsji.v11i2.3749