# Streamlined 15-min HIV Viral Load Self-Testing Using Finger-Stick Blood

> **NIH NIH R61** · JOHNS HOPKINS UNIVERSITY · 2020 · $475,146

## Abstract

The revolutionary advances in human immunodeficiency virus (HIV) antiretroviral therapy (ART) which could
reach and maintain viral suppression have gradually transitioned HIV/acquired immunodeficiency syndrome
(AIDS) to a manageable, chronic disease in the past 2 decades. However, it is still one of the leading public
threats in the world with approximately 37.9 million people living with HIV (PLWHA), 1.7 million new infections,
and 770,000 HIV-related deaths in 2018. As a comprehensive strategy for improving the clinical management of
HIV, the World Health Organization (WHO) specifically calls for improved accessibility of not only ART, but also
HIV testing to reach untested high-risk populations and to help PLWHA ascertain their viral load (VL) and
potential for transmission. In response, this project seeks to develop a diagnostic technology for rapid, affordable
and easy-to-use HIV VL detection that is amenable for self-testing and even in-home testing. Unlike conventional
diagnostic technologies that are impractical for self-testing due to requirements of sophisticated devices and
instruments, our platform employs magnetofluidic technology to replace bulk fluid transport with magnetic particle
manipulation, enabling the integration of sample processing and PCR without the need for complex fluidic
cartridges and supporting instrumentation. Miniaturization of instrumentation and assay facilitated by
magnetofluidics minimizes reagent consumption and the thermal mass, leading to >10-fold reduction in cost and
assay time. The integrated device facilitates HIV RNA detection from finger-stick blood in a facile “sample-to-
answer” manner, promising a rapid, inexpensive and user-friendly strategy for VL self-testing.
We have assembled a multi-disciplinary team with complementary expertise and strong track record and history
of collaboration in team science. In order to achieve the above goal, we propose (i) to develop a streamlined
assay protocol for sample processing and PCR detection of HIV in whole blood, (ii) to develop an inexpensive
magnetofluidic cartridge implementing the HIV detection assay as a simple blood-to-result test, (iii) to develop a
portable instrument to enable facile HIV self-testing, (iv) to develop a method for ambient cartridge storage, and
finally (v) to evaluate performance and patient acceptability of the HIV self-testing platform in both acute care
and resource-limited settings. The development of this HIV VL self-testing technology has the potential for
dramatically increasing the accessibility of detecting acute infections and monitoring viral suppression in PLWHA,
thus presenting a game changer in the global HIV prevention strategy.

## Key facts

- **NIH application ID:** 10065791
- **Project number:** 1R61AI154628-01
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Yu-Hsiang Hsieh
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $475,146
- **Award type:** 1
- **Project period:** 2020-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10065791

## Citation

> US National Institutes of Health, RePORTER application 10065791, Streamlined 15-min HIV Viral Load Self-Testing Using Finger-Stick Blood (1R61AI154628-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10065791. Licensed CC0.

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