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RNA Detection as an Improved Diagnostic Assay for Human Leptospirosis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI114064-01
Agency Tracking Number: R41AI114064
Amount: $600,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA10-124
Solicitation Year: 2015
Award Year: 2014
Award Start Date (Proposal Award Date): 2014-07-01
Award End Date (Contract End Date): 2016-06-30
Small Business Information
BOX 8175
New Haven, CT 06530-0175
United States
DUNS: 142406110
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (203) 503-0383
Business Contact
Phone: (203) 393-9439
Research Institution
NEW HAVEN, CT 06520-8327
United States

 Nonprofit College or University

DESCRIPTION provided by applicant Leptospirosis a zoonotic disease is an important public health problem worldwide It is caused by spirochete bacteria belonging to nine species and more than serovars of the genus Leptospira In the US there is increasing awareness of the importance of leptospirosis as the cause of disease among inner city populations military personnel and individuals engaged in swimming and water sports Worldwide leptospirosis imparts its greatest burden on subsistence farmers and urban slum dwellers Antimicrobial agents appear to be of greatest benefit when initiated early in the disease process However current laboratory diagnostic tests for leptospirosis rely on antiquated methods and suffer from low sensitivity especially in the first days of illness Existing PCR methods to detect Leptospira
DNA only have a sensitivity of approximately We propose to implement a novel testing modality to detect Leptospira bacteria in human blood and urine samples Our preliminary results demonstrate that a greatly higher sensitivity can be achieved through the PCR amplification of cDNA molecules derived from S RNA Such a method is expected to be markedly more sensitive because of the abundance of S RNA over that of genomic DNA We will design primer pairs that successfully detect S RNA from all pathogenic species of Leptospira We will then use human blood and urine samples spiked with known concentrations of Leptospira bacteria to compare the performance of three different amplification methods real time PCR amplification with or without a fluorescent TaqMan probe droplet digital PCR a very novel amplification technique with improved sensitivity and specificity over real time PCR and recombinase polymerase assay amplification a low cost technology which may be particularly suitable as a point of care implementation in resource poor settings We will determine a lower threshold of detection for each amplification method and estimate the cost per sample analyzed We will then determine how well our test performs using existing samples collected from patients with leptospirosis and samples collected from healthy controls At the conclusion of Phase I we will select primer pairs and a platform technology for further development In Phase II experiments we will conduct a prospective study in multiple sites worldwide in order to compare the performance of our assay with that of existing tests

PUBLIC HEALTH RELEVANCE Leptospirosis is a disease caused by an infection that is transmitted through contact with water It affects US residents engaging in water recreational activities military personnel and travelers to tropical destinations In addition it affects man people living in resource poor countries We propose to develop a sensitive diagnostic test which would ensure that all infected patients receive appropriate treatment with antibiotics

* Information listed above is at the time of submission. *

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