The primary goal of this proposed project is to develop a point-of-care diagnostic assay and platform for the detection of Clostridium difficile from human stool. Two additional goals are to detect the hypervirulent strain of C. difficile B1/NAP/027 and to detect C. difficile spores from swabs of medical devices. C. difficile associated disease (CDAD) is now the most common healthcare acquired infection in the United States with an estimated three million CDAD cases per year, costing $1- 3.2 billion per year. The frequency of C. difficile acquisition is estimated to be 13% in patients with hospital stays of up to two weeks, and 50% in those with hospital stays longer than four weeks5. Bringing detection of C. difficile to the point-of-care setting will facilitate more timely treatent for patient, as well as reduce the risk of spread of the disease. The capability to monitor surfaces for C. difficile contamination is a unique contribution of this project. Hospitals, nursin homes, and rehabilitation facilities, both nationally and globally, will welcome the ability to monitor the burden of environmental contamination by C. difficile and its spores, respond with infection control procedures accordingly, and verify that those changes have achieved the desired result. Claremont BioSolutions (CBio) is developing an integrated disposable assay device and platform that is based on the combination of our proprietary disposable cartridge for sample preparation, PureLyse(R), that can mechanically lyse cells and extract DNA in less than five minutes, with a rapid isothermal nucleic acid amplification system, both embedded into a disposable device. The platform provides detection of the amplification product and is based on CBio's portable FluoriSense" fluorometer. The PureLyse(R) chamber will be mounted within our novel OmniValve" to create an assay device that lends itself to rapid and efficient manufacturing.

Public Health Relevance

Clostridium difficile has recently become the most common hospital-acquired infection in the United States. We propose to develop a point-of-care assay and portable platform for detecting Clostridium difficile from human stool and from swabs of medical devices based on the combination of (1) our novel PureLyse(R) rapid and disposable sample preparation system that can lyse cells and extract DNA in less than five minutes, (2) rapid isothermal amplification of DNA, and (3) fluorescence detection with our FluoriSense(R) portable fluorometer.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44AI078619-04
Application #
8500118
Study Section
Special Emphasis Panel (ZRG1-IDM-V (12))
Program Officer
Hall, Robert H
Project Start
2008-04-01
Project End
2015-06-30
Budget Start
2013-07-01
Budget End
2014-06-30
Support Year
4
Fiscal Year
2013
Total Cost
$1,000,000
Indirect Cost
Name
Claremont Biosolutions, LLC
Department
Type
DUNS #
781016386
City
Upland
State
CA
Country
United States
Zip Code
91786