# Feasibility and development of an automated HIV self-testing system

> **NIH NIH R61** · DIAGNOSTICS FOR THE REAL WORLD, LTD · 2020 · $416,646

## Abstract

PAR-17-471: Detection of HIV for Self-testing (R61/R33)
Feasibility and development of an automated HIV self-testing system
Abstract
 Diagnostics for the Real World Ltd (DRW) has developed and CE-marked its SAMBA II platform for
sample-in result-out point of care (PoC) testing, with tests for HIV acute infection and vial load monitoring.
SAMBA II uses pre-loaded, ready-to-use cartridges containing all required reagents, which can be shipped and
stored at room temperature. SAMBA II is a fully automated, PoC testing system incorporating sample extraction,
nucleic acid amplification, detection and interpretation of results. Results are automatically read and can be
printed and sent via SMS messaging to a mobile phone or any cloud–based or secure database.
 DRW will exploit development and field experience from SAMBA II to develop an innovative system for
HIV self-testing: SAMBA III. It will aim to be as easy to use as a pregnancy test or blood glucose test: a user will
only need to collect a whole blood sample from a finger prick, add it to a device or cartridge to automatically
process the sample and return a result. Development will involve chemistry and a device.
 The main aims of the chemistry development during the R61 phase will focus on reducing the assay time
and simplifying the chemistry for automation with the current SAMBA chemistry as a starting point. Chemistry
development will focus mainly on (1) improving the detection of Group O subtype; (2) simplification of nucleic
acid extraction from whole blood; (3) simplification and reduction in time of the amplification/detection method.
 The chemistry will be processed in a new SAMBA III cartridge and device, the latter to supply temperature
control, fluid handling and results reading. The project will be challenging and DRW will also pursue an alternative
strategy of reductions of size, weight and cost to the current SAMBA II system to allow it to be used for self-
testing.
 Overall direction and project management will be done by DRW in California along with the main
chemistry development, quality, system testing, sample testing and regulatory management, including field
performance evaluation. The current SAMBA II chemistry, cartridge and instrument were originally developed
by personnel at DRW’s subsidiary in the UK, Diagnostics for the Real World (Europe) Limited, therefore a portion
of the work proposed in this application will be done by DRW Europe in the UK.
 If the R61 Phase succeeds, DRW will continue with an R33 phase. The work for this phase will involve
finalizing and optimizing the cartridge and device design, further develop manufacturing capabilities for the new
system, evaluate test performance, including sensitivity, specificity and testing actual clinical samples and
useability.

## Key facts

- **NIH application ID:** 10004563
- **Project number:** 5R61AI140471-02
- **Recipient organization:** DIAGNOSTICS FOR THE REAL WORLD, LTD
- **Principal Investigator:** HELEN H LEE
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $416,646
- **Award type:** 5
- **Project period:** 2019-08-31 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10004563

## Citation

> US National Institutes of Health, RePORTER application 10004563, Feasibility and development of an automated HIV self-testing system (5R61AI140471-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10004563. Licensed CC0.

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