# V-OLA: point-of-care HIV viral load monitoring and drug resistance testing

> **NIH NIH R01** · UNIVERSITY OF WASHINGTON · 2022 · $687,984

## Abstract

ABSTRACT
We will develop the first test for detection of viral load (VL) and HIV drug resistance (DR) that is appropriate for
low-resource settings (LRS). This new test is based on years of experience developing and testing the
Oligonucleotide Ligation Assay (OLA) for HIV DR, as well as our recent work to develop OLA-Simple – a lab kit
that reduces the time and complexity of OLA, but still requires laboratory equipment, laboratory one-way
workflow to prevent contamination by amplicons, and hands-on operation of multiple steps. The proposed V-
OLA test is a major advance over OLA-Simple that uses innovative technologies coordinated to give a low-cost,
streamlined test suite appropriate for HIV patient management. We will develop rapid sample preparation from
whole blood, semi-quantitative VL measurement at clinically-relevant thresholds (current WHO cut-off for
treatment failure is >1000 copies/mL), and an integrated test cartridge to identify HIV DR mutations (goal to
detect 10% mutant for patients with VL >1000 copies/mL). In Aim 1, we will develop chemistry and sample
preparation format for HIV RNA isolation compatible with a rapid VL test. In Aim 2, we will develop the VL test
using semi-quantitative isothermal amplification, including a simple low-cost heat block and detector. In Aim 3,
we will develop core OLA chemistry including isothermal amplification of DR target regions, ligation on single-
stranded amplicon, and dry reagents for amplification and OLA; we will test assays on different HIV subtypes. In
Aim 4, we will develop the integrated DR detection device, including isothermal amplification and ligation with
lateral flow strip detection. In Aim 5, we will combine the VF and DR tests into a coordinated system including
refining hardware, scaling up fabrication of kit disposables, and develop a digitally-assisted system – called
Aquarium – to provide step-by-step guided protocols, sample tracking, results interpretation, and scheduled
quality control tests. We will test V-OLA on banked HIV plasma samples (HIV-1 subtypes of A, C, D, and AE).
This level of testing is intended to provide preliminary evidence for in-depth studies on performance, usability,
and implementation.

## Key facts

- **NIH application ID:** 10407553
- **Project number:** 5R01AI145486-04
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Barry Ryan Lutz
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $687,984
- **Award type:** 5
- **Project period:** 2019-06-14 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10407553

## Citation

> US National Institutes of Health, RePORTER application 10407553, V-OLA: point-of-care HIV viral load monitoring and drug resistance testing (5R01AI145486-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10407553. Licensed CC0.

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