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Landscape of RDT-reading apps

Rapid diagnostic tests (RDTs) based on lateral flow assays have emerged as important diagnostic tools in the management of diseases such as malaria and COVID-19. However, errors can arise when individuals perform these tests and interpret their results. Mobile smartphone applications (apps) for reading RDTs offer a promising option to improve the accuracy of the interpretation of test results. This has been demonstrated with hardware RDT readers in low- and middle-income countries (LMICs). With apps, however, no additional hardware is needed, apart from a smartphone. Such smartphones are already becoming widely available, avoiding cost, supply chain, and maintenance concerns that would occur if new hardware needed to be deployed to read RDTs. 

The aim of this report is to share a summary of publicly available information about mobile applications for reading RDTs. The focus is on RDT-reading apps that do not require additional hardware beyond a mobile device (meaning a smartphone or tablet) and the RDT kit. Apps for diseases of poverty and low-resource settings are of particular interest, but the report also includes other apps, to support an understanding of this industry overall.

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Target Product Profile for Readers of Rapid Diagnostic Tests

Rapid diagnostic tests (RDTs) have played a critical role in the global COVID-19 response, as well as in the management and diagnosis of other diseases, such as malaria and HIV. However, without correct performance of the test and interpretation of the result, the utility of these tests may be compromised, presenting timely and accurate clinical assessment and disease surveillance. 

This Target Product Profile lays out minimal and optimal characteristics for RDT readers to serve as companion tools to support improved test performance, interpretation, and reporting.  

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US$7 million investment accelerates availability COVID-19 self-tests in low- and middle-income countries

Key takeaway: Successful applicants to manufacture 240 million low-priced tests a month.

On March 31 2021, FIND launched a request for proposals (RFP) to develop, manufacture, and launch to market COVID-19 self-tests in low- and middle-income countries (LMIC). 

The RFP called for quality-assured and easy-to-use self-tests that were accurate and affordable. It was prepared in the context of the Access to COVID-19 Tools (ACT) Accelerator Diagnostics Pillar, co-convened by FIND and the Global Fund.

Innovators, developers and manufacturers of in vitro diagnostics, and LMIC-based diagnostic stakeholders, were invited to submit proposals.

A package of US$7 million was offered in support, funded via grants to FIND from the German Federal Ministry of Education and through KfW and other donors.

International expertiseFrom 80 applicants, contracts were signed with four companies, and their names announced in February 2022:

Each has committed to manufacturing up to 60 million tests per month, priced from US$1–2 per test.FIND will conduct independent clinical evaluations of test performance, with support dependent on meeting project milestones.

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US$21-million investment in molecular diagnostic platforms

FIND chooses four firms with promising new platforms for decentralized diagnosis of COVID-19 and other illnesses.

FIND is investing US$21-million to speed the development, manufacturing and launch of affordable, multi-pathogen, molecular diagnostic platforms.

These platforms are specifically aimed at decentralized settings in low- and middle-income countries (LMICs), and will detect different respiratory pathogens, including COVID-19.  

FIND launched the request for proposals in August 2021, in the context of the Access to COVID-19 Tools (ACT) Accelerator diagnostics pillar, which it co-leads. 

The submission deadline was September and the successful firms announced on December 2021.

The four firms are:

The German Federal Ministry of Education and Research (BMBF) is funding the investments through KfW and other donors. 

Read the full report here