The global HIV/AIDS epidemic continues to be fueled by the large number of individuals who do not know that they are infected. The CDC is supporting programs to decrease this number by encouraging more frequent testing of all age groups as well as increasing the venues for testing including the recent FDA approval of an oral HIV Screening test for anti-HIV antibodies. That said, a reactive (i.e., positive) test still requies a confirmatory test that often requires a second visit to a health professional. Additionally, ther is a seroconversion window of many weeks from the time of infection until antibodies to the virus can be detected. In this interval HIV viral loads are at their highest levels, increasing the chance for transmission to other individuals. Over the past several years, Rheonix Inc. and NYU have been collaborating on a novel point-of-care device to simultaneously detect both anti-HIV antibodies and viral nucleic acid in less than 1 hour. Starting with a drop of blood or a saliva sample, we have been able to combine a screening test (antibody) using lateral flow with a confirmatory molecular test for viral RNA utilizing isothermal amplification (LAMP). Employing Rheonix's patented technology, the device being developed utilizes a microfluidic-based disposable CARD that can be simply operated with the push of a button to provide a yes/no result for both antibody and nucleic acid in less than 60 minutes on a device that is portable and practical for both small clinics or field use. The results from the present fast-track SBIR proposa will complete the development of this dual pathway device in 2 years utilizing our preliminary data on all aspects of this innovative approach. The impact of the dual pathway point-of-care approach will permit a test and treat program to rapidly identify infected individuals and accelerate their treatment, ultimately decreasing the viral burden in a community.

Public Health Relevance

The ability to rapidly and accurately determine if an individual is infected with HIV, especially in low resource settings, is critical to reducing the number of worldwide infections. By developing a fully automated, unattended system that will detect both antibodies to HIV and HIV viral RNA, individuals of moderate skill level will be able to perform very sophisticated immunoassays and molecular confirmatory assays in a single device by merely introducing the sample and allowing the system to automatically perform all preparative, analytical and readout steps. Moreover, since viral RNA is detectable sooner than antibodies directed against HIV, early infections that might have otherwise gone undetected using standard immunologic techniques can be detected and permit immediate access to therapy. A device that can accept either blood or saliva will likely have greater acceptability and provide a marketing advantage. PHS 398/2590 (Rev. 06/09) Page 1 Continuation Format Page

Agency
National Institute of Health (NIH)
Institute
National Institute of Dental & Craniofacial Research (NIDCR)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44DE024456-03
Application #
8998018
Study Section
Special Emphasis Panel (ZRG1-AARR-E (81))
Program Officer
Rodriguez-Chavez, Isaac R
Project Start
2014-04-02
Project End
2016-06-30
Budget Start
2016-01-01
Budget End
2016-06-30
Support Year
3
Fiscal Year
2016
Total Cost
$496,122
Indirect Cost
Name
Rheonix, Inc.
Department
Type
DUNS #
809809275
City
Ithaca
State
NY
Country
United States
Zip Code
14850
Sabalza, Maite; Yasmin, Rubina; Barber, Cheryl A et al. (2018) Detection of Zika virus using reverse-transcription LAMP coupled with reverse dot blot analysis in saliva. PLoS One 13:e0192398
Sabalza, Maite; Barber, Cheryl A; Abrams, William R et al. (2017) Zika Virus Specific Diagnostic Epitope Discovery. J Vis Exp :
Modak, Sayli S; Barber, Cheryl A; Geva, Eran et al. (2016) Rapid Point-of-Care Isothermal Amplification Assay for the Detection of Malaria without Nucleic Acid Purification. Infect Dis (Auckl) 9:1-9
Chen, Zongyuan; Zhu, Hui; Malamud, Daniel et al. (2016) A Rapid, Self-confirming Assay for HIV: Simultaneous Detection of Anti-HIV Antibodies and Viral RNA. J AIDS Clin Res 7: