Development of a high-sensitivity reader for improving use of malaria RDTs

Since introduced in the 1990’s rapid diagnostic tests (RDTs) have had a dramatic impact on the diagnosis of malaria infections evidenced by approximately 276 million malaria RDTs deployed in 2017 alone. While light microscopy (LM) is still commonly used in many malaria endemic settings, RDTs often provide a result more quickly and can be performed by staff with minimal training. Current RDTs do have several limitations however. Because RDTs are designed as a visual test, errors can occur when test lines are interpreted incorrectly, especially when parasite levels are low and test lines are faint as a result. This also means that low parasite levels can be completely missed and a false diagnosis may be given (i.e. the infection is missed and therefore not treated). As the test result is visually interpreted, the final result may also be inadequately recorded and reported. This again can lead to an incorrect diagnosis and also to delays in reporting results to public health surveillance databases. RDTs also have limited quality control once deployed to the field.

Mobile phones and phone apps are very unlikely to provide an adequate solution for this problem due to the requirement for in-vitro diagnostics and support instruments to meet strict international regulatory requirements, thus requiring complex data packs for product development, manufacturing and test validation.This project will overcome these limitations by: developing a novel RDT reader to objectively capture test results, monitor RDT quality, and transmit test result data in real-time.

This work will include hardware and software development including optimisation of instrument optics, and a cartridge drawer specifically designed to house the malaria RDTs used by the NMCPs in PNG and Bangladesh. It will also include optimisation of software algorithms to quantify the intensity of the test lines and call positive, negative and invalid results. Work on the instrument hardware and software will be performed at Axxin as an in-kind activity. Parallel work on extra functionality for GPS and other modes of data transmission will depend on the success of other funding applications.

Diagnostics
Product Development

May 2019 — Oct 2023

$15,000

Australia
Bangladesh
Papua New Guinea

Australian Centre for Research Excellence in Malaria Elimination (ACREME)