# RADx Tech HIV

> **NIH NIH U54** · JOHNS HOPKINS UNIVERSITY · 2022 · $1,199,776

## Abstract

Project Summary
The Johns Hopkins Center for Point-of-Care Technologies Research for STDs aims to accelerate the
development of over-the-counter HIV self-tests as well as HIV viral load point-of-care in vitro devices using the
Rapid Acceleration of Diagnostics Technology (RADx Tech) model. This RADx Tech program was developed
to address the COVID-19 pandemic and the emerging and urgent need to increase the number of tests
available to Americans to know their status and diagnose infection either as OTC self-tests or POC in vitro
devices. This hybrid approach with increased central laboratory testing moved the infectious diseases testing
paradigm toward point-of-need. The HIV epidemic is now in its 4th decade. The critical role of diagnostics in
identifying people living with HIV and linking them to treatment or prevention has been highlighted by the
United Nations Programme on HIV/AIDS. We propose to select, fund, and support HIV POC IVD as well as
self-tests to accelerate the attainment of critical milestones to derisk promising IVD. We will create a laboratory
verification core to test general diagnostic performance of devices against a spiked plasma panel and to
perform desktop evaluations with blinded panels for performance, userability, hands-on time, and turnaround
time. We will provide companies with clinical use case consultation through the Clinical Review Committee, as
well as prospective pre-clinical pilot testing when appropriate. Our group is ideally placed to leverage existing
infrastructure and expertise in clinical POC diagnostic evaluation, deep HIV clinical and laboratory expertise,
and a variety of CAP accredited labs for gold-standard testing.

## Key facts

- **NIH application ID:** 10693440
- **Project number:** 3U54EB007958-15S2
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Yukari C Manabe
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,199,776
- **Award type:** 3
- **Project period:** 2007-09-30 → 2023-09-12

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10693440

## Citation

> US National Institutes of Health, RePORTER application 10693440, RADx Tech HIV (3U54EB007958-15S2). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10693440. Licensed CC0.

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