Direct Detection of Tick-Borne Agents in a Single Point-of-Care Test
Abstract
Low accuracy and the inability to simultaneously target the wide range of potential causative pathogens are the primary limitations of direct tests for tick-borne diseases. Currently, optimal laboratory diagnosis requires a wide range of individual, costly tests that may fail to detect the causative pathogen. The lack of accurate early diagnosis can then lead to improper therapy and to persistent and long-lasting symptoms. Thus, accurate early detection is critical, and requires a test that provides superior simultaneous detection of a wide spectrum of tick- borne agents. Just as important, this test needs to be based on methods and equipment that are already widely available and can be adapted in any diagnostic laboratory. To overcome current testing limitations, we have developed a diagnostic test called TBDCapSeq that is based on a technique called Next Generation Sequencing (NGS). This technique has been progressively used for over 15 years and has rapidly improved all facets of clinical research. NGS tests do not focus on a single pathogen, but instead provide specific information about all microbes present within a tested sample. The primary limitation for using NGS-based diagnosis were the very high costs of the tests and the complexity of the machines and the analysis process. However, new small, cheaper and portable machines have offset these limitations. Based on the speed of current technological innovation, we anticipate that in the next decade portable NGS tests will begin to replace currently used PCR tests as the primary point of care diagnostic platform. Portable NGS also provides a unique immediate opportunity for improvement of tick-borne disease testing. In our previous published work, we have demonstrated the superior accuracy of our TBDCapSeq assay and its ability for simultaneous detection of multiple agents. Our efforts in this project will be focused on adapting our existing assay to these new cheaper and portable sequencers. Concurrently, we will approach the Food and Drug Administration (FDA) and follow their guidelines for thorough assay validation necessary to obtain regulatory approvals for diagnostic use. These experiments will be completed within a 2-year frame. With this work we will address multiple components of the Diagnosis Focus Area of the Fiscal Year 2022 Tick-Borne Disease Research Program. The availability of TBDCapSeq would fulfill the following crucial needs: (i) Rapid direct detection of any tick-borne agent in a single assay; (ii) The ability to detect all tick-borne co-infections; (iii) Uncover the emergence of new pathogen variants; and (iv) Reduce costs associated with direct testing. Following the validation experiments and FDA approval, TBDCapSeq could be adapted in any clinical laboratory. We would first pursue implementation of our assay for tick-borne disease testing within the department of Pathology at Columbia University. Concurrently, we would seek out commercial partners in order to facilitate commercial availability to the diagnostic community. Our assay would considerably impact patient care of military and civilian patients by improving early diagnosis. In addition, patients would now be tested for a full range of tick-borne agents, increasing the likelihood of detecting co-infections. And by greatly reducing the costs associated with testing, TBDCapSeq would provide affordable testing for the military Service Members as well as the civilian population.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310830
Entities
People
- Rafal Tokarz
Organizations
- Columbia University
- United States Army