There is an urgent need for a point-of-care (POC) test to detect HSV that could be used to identify at-risk patients, in particular neonatal patients. A rapid, point-of-care (POC) test that could detect HSV infections would: (1) allow for immediate counseling and additional specimen collection for confirmatory testing, and (2) avoid having to create new laboratory infrastructure for widespread biospecimen testing. We propose develop a POC test for rapid screening of HSV in clinical specimens. This technology will also result in a significant cost reduction as compared to hospital and clinical pathology laboratory tests. The goal of this project is to develop an inexpensive and rapid (<30 min from specimen to result) screening assay for HSV infections.

Public Health Relevance

Infections with herpes simplex virus type 1 (HSV-1) or type 2 (HSV-2) are highly prevalent worldwide. Both HSV types commonly cause genital infection; primary and reactivation of HSV increases the risk of transmission to the fetus or neonate. Many women infected with HSV are unaware of this risk because infection and reactivation are frequently asymptomatic. Neonatal HSV infection can have devastating long-term consequences, especially when the central nervous system is involved. Despite its strong disease association, there is no rapid (<30min), inexpensive POC diagnostic test for HSV. The goal of this project is to develop a rapid, point-of-care (POC) test to detect HSV in clinical specimens. The availability of a POC test would significantly lower the barriers to widespread screening.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43AI152629-01
Application #
10005820
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Woodson, Sara Elaine
Project Start
2020-05-11
Project End
2021-04-30
Budget Start
2020-05-11
Budget End
2021-04-30
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Microgen, LLC
Department
Type
DUNS #
111389362
City
La Marque
State
TX
Country
United States
Zip Code
77568