# Integrating low-cost and versatile technologies to achieve colorimetric HCV and HIV detection from whole blood

> **NIH NIH R01** · EMORY UNIVERSITY · 2024 · $680,721

## Abstract

PROJECT ABSTRACT
In the United States alone, over 2 million people live with active hepatitis C virus (HCV) infections, and up to
140,000 new infections occur each year. Since 2013, highly effective direct-acting antiviral therapy has been
available, allowing HCV to be cured with short courses of well-tolerated medications. However, HCV
diagnostics now present the greatest barrier to elimination. The current diagnostic workflow involves two-
stage testing with initial screening for HCV antibodies followed by molecular testing for viral RNA. Therefore, an
accurate, simple, rapid, and affordable molecular test for viral RNA is needed to increase detection of
HCV and important coinfections (such as HIV), eliminate cumbersome two-stage testing, and allow rapid
planning of subsequent care after a single visit. The development of such an economical, rapid HCV
molecular test is the expressed purpose of the NIH Notice of Special Interest (NOT-AI-23-001) to which this
proposal is a response. However, two key barriers exist to low-cost implementation of molecular methods for
RNA viruses: 1) lack of automated stand-alone low-cost RNA extraction and stabilization technologies, and 2)
complicated designs and/or expensive proprietary detection technologies for isothermal methods. Research in
this proposal overcomes these barriers with novel chemistries and bespoke microfluidics to enable minimally
trained healthcare workers to perform on-demand HCV/HIV duplex molecular testing in the clinic. To do so, Aim
1 will adapt and automate RNA Sample Extraction and Stabilization (RNAES) technology for HCV/HIV RNA
extraction from capillary whole blood. Building on newly obtained preliminary results, the current protocol will be
streamlined to extract and store HCV/HIV RNA from plasma, RNAES technology will be adapted for whole blood,
and 3D-printed programmed stand-alone microfluidics will be created to automate RNAES and create a sample-
in, RNA-out device. Along with this, Aim 2 will apply chemical innovations and microfluidics to Transcription-
mediated amplification (TMA) for standalone colorimetric detection of HCV/HIV RNA. Preliminary data shows
that detection can be achieved with a colorimetric readout suitable for low-complexity settings and a simple hand-
mixed microfluidic will create a self-contained readout and avoid potential contamination from adding reagents
post-amplification. In Aim 3, external user testing and a clinical evaluation of the HCV/HIV detection system will
be performed in partnership with an external testing site at Stanford University. Separately, based on the final
RNAES whole blood device and workflow, a prospective study to test capillary blood samples from individuals
with HCV and/or HIV will be carried out. This proposal has been carefully designed to enable rapid scaling and
translatability to the market. Achieving either device from Aim 1 or Aim 2 will represent a significant advance that
can be leveraged to improve HCV testing. Com...

## Key facts

- **NIH application ID:** 10779734
- **Project number:** 1R01AI180093-01
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** David Richard Myers
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $680,721
- **Award type:** 1
- **Project period:** 2024-08-15 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10779734

## Citation

> US National Institutes of Health, RePORTER application 10779734, Integrating low-cost and versatile technologies to achieve colorimetric HCV and HIV detection from whole blood (1R01AI180093-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10779734. Licensed CC0.

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