Recombinant antigen-based antibody ELISA assay
for human leptospirosis serodiagnosis

Asst. Prof. Dr. Santi Maneewatchararangsri, et al.
Department of Molecular Tropical Medicine and Genetics, Faculty of Tropical Medicine,
Mahidol University, Bangkok 10400 Thailand

The Leptospira IgM- and IgG-ELISA tests are qualitative immunoassay by using
recombinant Leptospira proteins antigen for determining specific IgM- and IgG-antibodies for human leptospirosis serodiagnosis.


  1. Recombinant Leptospira spp. antigens.
  2. Early leptospirosis diagnosis.
  3. Differential leptospirosis serodiagnosis from acute undifferentiated febrile illness patients such as melioidosis, dengue fever, scrub typhus, malaria, and influenza.
  4. Epidemiological seroprevalence application.

Human leptospirosis is regarded as a neglected infectious zoonotic disease worldwide and continues to be a significant global public health problem. The disease outbreaks are frequently found in tropical and sub-tropical regions of lower-middle-income countries and in vulnerable population including Thailand. Laboratory diagnosis during early phase of infection is essential, and is important to assist specific and effective treatments, for clinical management of severe leptospirosis patients, and for prevention of disease complications.

With financially support from a Translational Medicine and Innovation Grant, Faculty of Tropical Medicine, Mahidol University, the Center of Excellence in Medical Biotechnology, and the S&T Postgraduate Education and Research Development Office, prototypes of “Recombinant antigen-based IgM- and IgG ELISA assay” have been developed in close collaborations with medical doctors, micro-immunologists, a pathologist, and a statistician at the Mahidol University in order to detect or screen specific IgM-and IgG to recombinant Leptospira antigens for acute undifferentiated febrile illness with suspected leptospirosis diagnosis on first week of fever.

The innovative Leptospira IgM- and IgG- ELISAs have shown high diagnostic accuracy, sensitivity, and specificity and the test demonstrated serological applicability for the differential leptospirosis among acute undifferentiated febrile illnesses, such as scrub typhus, dengue, malaria, influenza, and melioidosis. A patent of recombinant antigen-based ELISA assay is ongoing.

A rapid immunochromatographic diagnostic test for screening suspected leptospirosis patients in acute phase of infection will be further developed. A rapid test will be used at points of care to assist medical diagnosis for prompt treatments to save patients’ lives in hospitals or health promoting units that can be tested by health personnel or community volunteers.

Contact person:
Asst. Prof. Dr. Santi Maneewatchararangsri
Department of Molecular Tropical Medicine and Genetics
Faculty Tropical Medicine, Mahidol University
420/6 Rajvithee Rd., Rajthewee, Bangkok, 10400
Tel: 02-3069100 ext 2035; Fax: 02-3069139
E-mail: santi.man@mahidol.ac.th