# HIV-specific target capture and quantitative isothermal amplification for acute HIV diagnosis and treatment monitoring

> **NIH NIH R33** · UNIVERSITY OF WASHINGTON · 2021 · $745,986

## Abstract

Abstract
HIV can be effectively managed if people with HIV are identified and their virus is controlled by therapy.
However, many HIV-infected people do not know their HIV status, so increased access to testing is needed. In
addition, therapy can fail due to drug resistance or lack of adherence to therapy schedules, and tests are
needed to identify when therapy is failing for either reason. We will develop a test to diagnose HIV and detect
treatment failure that is simple enough for users to test themselves.
Aim 1. HIV-specific capture for sample preparation. We will develop a sample preparation system that directly
targets HIV virions via endogenous human antibodies bound to the virion surface, human markers on the
envelope, and HIV virion epitopes.
Aim 2. Core assay development. We will develop an isothermal amplification assay for HIV and design an
internal amplification control.
Aim 3. Fast and sensitive detection for HIV diagnosis. This work will build on core assay development (Aim 2)
but add enhancements for fast and sensitive amplification and detection and develop the core paper device. In
addition, we will test a hypothesis that test sensitivity can be increased by contribution of HIV genomic targets
from the cellular fraction.
Aim 4. Semi-quantitative test for viral rebound detection. We will build upon preliminary results showing
threshold-based detection to develop a semi-quantitative test that reports a yes/no for a single threshold and
can be ready by eye.
Aim 5. Device design, integration, and scale up for clinical testing (R33 Phase). In this Aim, we will refine the
design for robust operation, evaluate performance and reproducibility in-house, and scale-up to produce devices
for clinical testing.
Aim 6. Clinical testing in the US and South Africa (R33 Phase). We will evaluate the tests on fresh fingerstick
blood at clinical sites in Seattle, USA and Durban, South Africa to evaluate performance as a primary diagnostic
test (1 and 2) and as a test for virologic failure (3 and 4) by comparison to FDA-cleared tests.

## Key facts

- **NIH application ID:** 10423662
- **Project number:** 4R33AI140460-04
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Barry Ryan Lutz
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $745,986
- **Award type:** 4N
- **Project period:** 2018-08-01 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10423662

## Citation

> US National Institutes of Health, RePORTER application 10423662, HIV-specific target capture and quantitative isothermal amplification for acute HIV diagnosis and treatment monitoring (4R33AI140460-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10423662. Licensed CC0.

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