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Principal Investigator: Dr. Yung-Fu Chang
Contact Information: E-mail: yc42@cornell.edu - Phone: 607-253-3675
Sponsor: Cornell Center for Advanced Technology
Title: Development of a Dipstick Assay for Detection Leptospira-Specific IgM Antibodies
for Early Infection Diagnosis
Annual Direct Cost: $50,000
Project Period: 07/01/05-06/30/06
Leptospirosis is an important zoontic disease that affects humans on all continents in both urban and rural contexts, and in temperate and tropical climates. Infection leads to mostly renal and liver failure. The importance of pulmonary hemorrhage as a lethal complication of leptospirosis has become more widely recognized. Currently, more than 250 pathogenic Leptospira serovars have been identified. Leptospires are present in the blood until they are cleared after 4 to 7 days following the production of Leptospira-specific antibodies, initially mainly on the immunoglobulin M (IgM) class. The laboratory diagnosis of leptospirosis is largely based on serological methods. Several methods are available for this purpose. The microscopic agglutination test (MAT) is the cornerstone of the serodiagnosis of leptospirosis, because this assay has a high sensitivity and allows for the detection of group-specific antibodies. Unfortunately, the performance of MAT is restricted to laboratories that are capable of maintaining strains for the preparation of live antigens. Enzyme-linked immunosorbent assays (ELISAs) or indirect fluorescent-antibody tests are useful alternative or additional tests by virtue of their capacity to detect with a high sensitivity specific IgM antibodies as a sign of current or recent leptospirosis. Because of the relative complexity and costs of these assays they can only be performed in specialized laboratories, thus hampering the diagnosis and appropriate treatment of leptospirosis by practicing veterinarians. Therefore, we propose to develop a dipstick assay using multiple outer membrane antigens for quick diagnosis of early leptospiral infection.
We have identified 50 unique outer membrane genes from the genomic sequence. We propose to express
these recombinant proteins for the development of an effective dipstick test for the detection of IgM antibodies of animal leptospirosis. Unison Diagnostics, Inc is a company located in New York City and focused on the development of animal infectious disease diagnosis kits. Because leptospirosis is a reemerging disease of humans and animals, a reliable, quick and economical dipstick test for early diagnosis of leptospira infection will allow the veterinarians for timely treatment to save the lives of the animals. Unison Diagnostics, Inc needs our biotechnology techniques to help them to develop this new product. These novel strategies that we propose should lead to the development of a reliable dipstick test for early diagnosis of this disease.
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