A Rapid HIV RNA Detection without Sample Preparation CrossLife Technologies Inc. Project Summary/Abstract Early diagnosis of new infections and detection of emergence of viral rebound for individuals on treatment hold the key to effective management of HIV. Among many diagnostic approaches, self-testing has become increasingly acceptable in recent years, but immunoassay-based home tests are insufficiently sensitive for early diagnosis and incompatible with treatment monitoring. In this project, we propose to develop a rapid, sensitive, specific, simple, and cost-effective diagnostic technology for RNA detection in unprocessed blood samples. The proposed technology features unique chemistry innovations in biomolecular assays (TARA) and our ability in integrating and automating these innovations onto simple devices with precisely time-gated steps. The R61 phase (Aims 1-3) focuses on technology development, integration, and optimization; and the R33 phase (Aims 4-5) focuses on technology validation using archived samples and prospective clinical samples. These specific tasks will be carried out by a highly multidisciplinary team with well-established collaborations and complementary expertise. If successful, the test kit will enable diagnosis and viral load monitoring by individuals in their home or in a pharmacy and be appropriate for minimal-resource settings where HIV is most prevalent. Sensitive diagnosis and monitoring enable earlier treatment and reduce HIV transmission.

Public Health Relevance

A Rapid HIV RNA Detection without Sample Preparation CrossLife Technologies Inc. Narrative We propose to develop a rapid, sensitive, specific, simple, and cost-effective diagnostic ? ?TARApen? ? by integrating innovations in biomolecular recognition (TARA) and microfluidic design that address the key limitations of current home-test kits. The resulting TARApen test will automate all steps of molecular analysis and amplification for detection of HIV RNAs in blood finger-stick without sample preparation.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Project #
1R61HD101936-01
Application #
9837289
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Kapogiannis, Bill
Project Start
2019-09-12
Project End
2022-08-31
Budget Start
2019-09-12
Budget End
2020-08-31
Support Year
1
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Crosslife Technologies, Inc.
Department
Type
DUNS #
041375710
City
Carlsbad
State
CA
Country
United States
Zip Code
92008