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Rapid Test for Simultaneous Detection of Influenza (Types A and B) and Streptococcus (Group A)

Description:

 

Rapid Test for Simultaneous Detection of Influenza (Types A and B) and Streptococcus (Group A)

Phase I SBIR proposals will be accepted.

Fast-Track proposals will not be accepted.

Phase I clinical trials will not be accepted.

Number of anticipated awards: 1

Budget (total costs): Phase I: up to $150,000 for up to 6 months

PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

Background

The onset of influenza season sees increasing number of patients visiting clinics and hospitals that have symptoms similar to influenza caused by influenza types A and B, and strep throat caused by group A Streptococcus (GAS). There are several FDA-approved tests available, some of which are CLIA- waived, to detect separately influenza viruses and GAS in the patient specimens. These tests can take from less than 15 minutes (nucleic acid or antigen detection) to several days (culture-based assays). There is a need for an easy-to-use test in the field and health care settings for simultaneous detection of influenza types A and B, and GAS in the patient specimen. An early and accurate identification of the etiological agents will enhance surveillance, improve preparedness and response activities to a potential epidemic, inform use of proper prophylactics for responders, and ensure appropriate use of antiviral and/or antibiotics for patients before disease severity increases or further transmission occurs.

The applicant interested in this topic can develop new reagents, or use or modify reagents already available in the market and the research community to support the development of such a rapid point-of-care (POC) test. The offeror should document relevant biosafety experiences and availability of laboratory space at a biosafety level sufficient to work with influenza types A and B, and GAS.

Project Goals

The goal of this project is to develop a rapid POC diagnostic test that can simultaneously determine whether an individual is infected with influenza virus (types A and B) or GAS or both. The test should be simple, cost effective, non-invasive, demonstrate sensitivity and specificity greater than or comparable to the current POC tests, and have a potential of high throughput (running many samples at once for rapid testing). The test should employ reagents that can be stored under ambient conditions, and be compatible with U.S. regulatory guidelines for testing and validation. The final product should be compatible with POC use by healthcare personnel and field use by emergency responders, provide an instant color-coded readout preferably by direct observance or a portable electric/battery-operated analyzer for field use. Potential of such kit for use in home settings is desired but not required in Phase 1.

Phase I Activities and Expected Deliverables

Phase I activities can include but are not limited to:

1. Review of literature and preparation of a report about the current status of POC influenza type A and B, and GAS tests available in the market or reported in published literature. The report should also include information about test sensitivity, specificity, merits and limitations and the knowledge gap associated with these diagnostic tests.

2. Development of new reagents or modification of currently available reagents that can be stored at ambient temperature.

3. Test development to enable one-step simultaneous specific detection of influenza type A and type B, and GAS.

4. Validation of test specificity and sensitivity greater than or comparable to current tests

5. Test kit development, including instructions for use and result interpretation.

Impact

This research has potential to develop a rapid test that is easy to use in home, field and health care settings for simultaneous detection of influenza viruses and GAS in patient samples. These pathogens that have a substantial impact on human health and our economy at community and global level. The sensitive and specific test when developed could improve the public health preparedness and healthcare system’s appropriate response to a potential epidemic.

Commercialization Potential

There is a strong commercialization potential as the innovative research will lead to the development of a simple and rapid test to use in a home, field and health care settings for simultaneous detection of influenza viruses and GAS.

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