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Forum discusses research agenda for SARS-CoV-2 antigen rapid diagnostic tests

Participants identify key questions to take technical and programmatic research forward.

ACT-Accelerator diagnostic pillar partners joined in a virtual forum to discuss the development of a collaborative operational research agenda for SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs). 

The forum, held on 29 October 2020, was organized around three breakout groups according to three thematic areas for SARS-CoV-2 Ag-RDTs:

  • Technical research
  • Programmatic research
  • Modelling

Group participants focused on understanding the performance of Ag-RDTs when implemented in real-world settings and across specific populations. 

Priority questions

  • Performance
  • Use cases
  • Samples
  • Bio-safety
  • Quality control
  • Training and delivery
  • Economics and cost.

Participants discussed steps to advance the Ag-RDT research agenda and agreed that there should be multiple future discussions on this. 

Read the report here

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Rapid diagnostic tests for COVID-19

Key takeaway: Both types of RDTs are crucial for effective public health management.

Rapid diagnostic tests (RDTs) for COVID-19 can detect either antigen (Ag) or antibody (Ab), and both types of tests have important roles.

A combination is needed for effective patient management and public health planning.

This May 2020 report outlines general information on Ag- and Ab-detection RDTs for COVID-19, and suggested uses for them.

Polymerase chain reaction (PCR) or Ag

  • Directly detects the virus and should be prioritized for diagnosis and monitoring
  • Prioritize for case management to enable decentralized testing – particularly where PCR testing is limited.

Immune response tests or Ab

  • Tests detecting viral immune response tests can be complementary for clinical care
  • Should be prioritized for seroprevalence and epidemiological purposes
  • Prioritize Ab RDTs for seroprevalence surveys to inform public health measures and testing of contacts to establish previous viral spread.

The value of any test is dependent on factors such as the test performance, or sensitivity/specificity, as well as the epidemiological context, or prevalence in the population where it is used, and timing.

The report also lists unique features of SARS-COV-2 to consider when using RDTs and specifies operational characteristics, such as how to interpret test results. 


Read the report here

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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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Call to boost access to cheaper rapid diagnostic tests

Key takeaway: RDT agreements boost local manufacturing to supply millions of low-cost, high-quality tests for lower-income nations.

In July 2020 FIND and Unitaid launched a call via the Access to COVID-19 Tools Accelerator Diagnostics Pillar for expressions of interest (EOI) to speed up availability and scale up manufacturing of rapid diagnostic tests (RDTs) for COVID-19.

The EOI was geared towards increasing supply of regulatory approved, fit-for-purpose SARS-CoV-2 Ag RDTs that met WHO criteria of quality, cost and accessibility. This was particularly needed in low- and middle-income countries (LMICs).

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

Interventions included:

  • Accelerating late-stage product development and optimization
  • Facilitating technology transfer activities
  • Conducting performance evaluation studies to support regulatory submissions
  • Increasing production capacity
  • Addressing supply chain challenges
  • Strengthening local capacity for development and deployment of new tests within national testing strategies. 

Driving down prices and supporting the use of less invasive specimens to enable faster LMIC uptake were also critical. 

Over 100 applications were received, with 34 selected for review by a panel of external experts. 

A first collaboration, with Premier Medical Corporation in India, was announced in January 2021. By July that year, additional technology transfer agreements were signed with stakeholders in Africa and Latin America.

These included an agreement with DCN Dx to transfer know-how to WAMA Diagnóstica (Brazil), and with Bionote and Mologic to transfer know-how to DIATROPIX of the Institut Pasteur de Dakar (Senegal). 

There is a separate partnership between Viatris (South Africa) and Guangzhou Wondfo Biotech (China).

These agreements will lead to a dramatic increase in local manufacturing, ultimately making more than 250 million low-cost (US$2–2.50) tests available for LMICs. 

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SARS-CoV-2 diagnostic use cases

Nine examples of when to use COVID-19 investigative procedures

FIND has supported partner Halteres Associates in developing diagnostic use cases for SARS-CoV-2 tests, which highlight the comparison, contrast and implications for each. 

This report outlines nine diagnostic use cases where further assays or investigative procedures are warranted. 

It provides a description of each use case, other possible technologies required, more information on the sample and comments.

Use cases for SARS-CoV-2 assays

  1. Triage of symptomatic individuals in an epidemic setting
  2. Triage of symptomatic individuals in endemic settings
  3. Triage of at-risk pre-symptomatic and symptomatic individuals in endemic settings
  4. Confirmatory testing
  5. Diagnosis of symptomatic individuals in endemic or epidemic settings
  6. Differential diagnosis in endemic or epidemic settings
  7. Previous SARS-CoV-2 exposure
  8. Surveillance in sites of previous or potential outbreaks
  9. Environmental monitoring.

Learning curve
Before developing systems, however, it is essential that test developers understand the details of use cases for SARS-CoV-2 testing. 

This includes who will be tested, by whom, the site of testing, using which samples, under what conditions, and what the minimum acceptable clinical performance requirements are likely to be. 

The most important component is intended use: what clinical decision the test will enable, and in what patient population. 

For more information, contact us or Halteres Associates.

Read the full text here

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How genomics can help track new SARS-CoV-2 variants

Sequencing data key for monitoring virus and understanding impact of therapeutics.

This report on SARS-CoV-2 variants, developed and published for FIND (11 March, 2021) by PHG Foundation, explains how genomics helps to monitor the evolution of coronavirus “variants of concern”, or VOCs.

It outlines how genomic surveillance and sequencing have supported identification of new variants as well as the impact these variants have had on diagnostic tests and public health measures. 

This process has also significantly advanced vaccine design and development. 

Ongoing surveillance is required not only for known VOCs, but also for new “variants of interest” (VOIs).

Thinking ahead
Data produced has enabled further understanding of the variants, helping to inform future surveillance and the impact mutations may have on vaccines, diagnostics and therapeutics. 

Various countries have invested in sequencing infrastructure and resources to help combat the virus, and have put public health measures in place in response. 

Continued investment in sequencing capabilities and data sharing, as well as a variety of skills and expertise from multiple backgrounds, is needed to make genomic surveillance successful. 

In addition, it is important to limit the spread of the virus to prevent the emergence of additional variants which may be even more transmissible. 

Sequencing data continues to be key for monitoring the virus and understanding the impact of therapeutics.

An appendix on resources actively monitoring VOCs is included.

Read the full report here