Ultrasensitive Multiplexed Laboratory Test for Clostridium difficile Toxins
Abstract
The proposed project will address the Fiscal Year 2015 Peer Reviewed Medical Research Program Topic Area of Healthcare-Acquired Infection Reduction by developing a new modality to identify individuals with Clostridium difficile infection (CDI). The goal of the program is to develop a new highly sensitive diagnostic test that is capable of identifying individuals with active CDI and help determine disease severity. CDI, caused by a bacterium, is the leading cause of hospital-acquired diarrhea in the United States. Although the condition can cause only mild diarrhea, severe cases can be fatal. The incidence of CDI has been on the rise in the United States and among Veterans in Department of Veteran Affairs (VA) medical centers, becoming a significant cause of sickness and death in patients in hospitals or long-term care facilities. The presence of the bacterium in the large intestine does not necessarily lead to disease, as individuals can carry the bacteria without exhibiting symptoms. During active disease, the bacterium releases toxins, toxin A and toxin B, which are proteins that cause damage to the large intestine, resulting in diarrhea. Although numerous tests are available to identify CDI, diagnosis is complex as no adequate test exists that can accurately and rapidly diagnose individuals with active CDI. Accurate diagnosis of CDI requires detection of C. difficile toxins; however, tests that detect C. difficile toxins are either complicated to run, take days to perform, or do not identify everyone with the disease. Recently developed tests can confirm the presence of bacteria by detecting bacterial genes; although rapid, these tests are inaccurate as they cannot identify patients that carry the bacteria normally from those that have an ongoing infection. In the proposed program, a new highly sensitive laboratory test that can detect C. difficile toxins A and B in stool will be developed. The new test will use a novel technology that is much more sensitive than current tests (by approximately 100 to 1000 times). Previous research in animals and humans suggests that sicker patients have more C. difficile toxins in their blood. In this program, the new test will be run on blood samples to check if this is true. The development and testing of the proposed assays will provide a strong foundation for the development of a new test that will be better at identifying patients with active CDI. The proposed ultrasensitive test for toxins A and B has the potential to change the way in which CDI is diagnosed and managed.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 31, 2017
- Source ID
- W81XWH1610276
Entities
People
- Jeff Debad
Organizations
- Meso Scale Diagnostics (United States)
- United States Army