# Rapid, quantitative isothermal molecular assay for POC HIV-1 viral load monitoring using amplification nucleation site analysis

> **NIH NIH R21** · UNIVERSITY OF WASHINGTON · 2024 · $194,375

## Abstract

Project Summary
Over 20 million people living with HIV (PLHIV) are receiving antiretroviral therapy and require HIV viral load
testing to identify cases of virological failure and provide actionable information to guide alternative clinical
treatment. Current methods for HIV viral load measurement rely on quantitative PCR (qPCR) or digital PCR
(dPCR), which are commonly restricted to highly resourced central laboratories and there is a need to
decentralize HIV viral load monitoring to enable rapid, clinic-based or home self-testing viral load measurements.
We have identified a novel method for implementing digital isothermal amplification that leverages the
characteristic viscous reaction buffer of recombinase polymerase amplification (RPA) isothermal amplification
chemistry and commercially available porous membranes. We propose to apply amplification nucleation site
analysis (ANSA) for HIV-1 viral load monitoring to accurately quantify HIV-1 RNA over clinically relevant HIV-1
subtypes and viral loads. We propose two exploratory aims to demonstrate that ANSA can achieve the required
viral load dynamic range and quantitative precision across HIV-1 subtypes.

## Key facts

- **NIH application ID:** 10917341
- **Project number:** 5R21AI179267-02
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Jonathan D Posner
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $194,375
- **Award type:** 5
- **Project period:** 2023-09-01 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10917341

## Citation

> US National Institutes of Health, RePORTER application 10917341, Rapid, quantitative isothermal molecular assay for POC HIV-1 viral load monitoring using amplification nucleation site analysis (5R21AI179267-02). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10917341. Licensed CC0.

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