Global collaboration ensures Covid-19 antigen tests available in LMICs

The Access to COVID-19 Tools (ACT) Accelerator initiative has outlined a set of agreements to make available, for low and middle-income countries (LMIC), affordable, high-quality rapid SARS-CoV-2 antigen tests (Ag-RDT).

Organizations involved in the milestone agreement include the Africa Centres for Disease Control and Prevention (Africa CDC), the Bill & Melinda Gates Foundation, the Clinton Health Access Initiative (CHAI), the Foundation for Innovative New Diagnostics (FIND), the Global Fund, Unitaid, and the World Health Organization (WHO).

As part of this comprehensive, end-to-end effort, the Bill & Melinda Gates Foundation has executed separate volume guarantee agreements with rapid diagnostic test producers Abbott and SD Biosensor. These two arrangements will make available to LMICs 120 million Ag RDTs – priced at a maximum of US$5 per unit – over a period of six months. These tests provide results in 15-30 minutes, rather than hours or days, and will enable expansion of testing, particularly in countries that do not have extensive laboratory facilities or trained health workers to implement molecular (polymerase-chain reaction or PCR) tests.

The tests developed by Abbott and SD Biosensor are highly portable, reliable, and easy to administer, making testing possible in nearperson, decentralized healthcare settings. Both companies’ tests are faster and cheaper than laboratory-based tests, enabling countries to increase the pace of testing, tracing and treating people for COVID-19 at the point of care particularly in areas with under-resourced health systems. A number of other Ag RDTs are at various stages of development and assessment.

To scale up the Ag RDTs, the Global Fund announced in September that it has made available an initial US$50 million from its Covid-19 Response Mechanism to enable countries to purchase at least 10 million of the new rapid tests for LMICs at the guaranteed price. Dr Tedros Adhanom Ghebreyesus, director general of WHO, commented: “High-quality rapid tests show us where the virus is hiding, which is key to quickly tracing and isolating contacts and breaking the chains of transmission. The tests are a critical tool for governments as they look to reopen economies and ultimately save both lives and livelihoods.”

The Access to COVID-19 Tools (ACT) Accelerator, is a new, groundbreaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. It was set up in response to a call from G20 leaders in March 2020 and launched by WHO, the European Commission, France and the Bill & Melinda Gates Foundation in April 2020.

The ACT-Accelerator is not a decision-making body, but works to speed up collaborative efforts among existing organizations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines. The ACT-Accelerator has four areas of work: diagnostics, therapeutics, vaccines, and the health system connector. Cross-cutting all of these is the workstream on Access & Allocation.

The ACT-Accelerator Diagnostics Pillar is co-convened by FIND and the Global Fund, working closely with WHO and over 30 global health expert partners to accelerate innovation and overcome the technical, financial, and political obstacles to achieving equitable access to effective and timely testing. Such unprecedented global collaboration has enabled development and deployment of the first WHO EUL-approved Ag RDT within eight months of the first identification of the virus. In comparison, it took nearly five years to develop the first RDT for HIV. Several more antigen RDTs for Covid-19 are currently under WHO EUL review. Overall, the ACT-Accelerator Diagnostic Pillar aims to facilitate the supply of 500 million tests to LMICs within 12 months.

This is not just a new test – it’s the money and the deployment plan to get it to where it’s needed, fast. This is the power of global collaboration.

Peter Sands, executive director
Global Fund

Peter Sands, executive director of the Global Fund, said: “This is the ACT-Accelerator in action. It is proof that by working together at a massive global scale, we can develop and deploy a vital new tool to help contain and fight the pandemic. This is not just a new test – it’s the money and the deployment plan to get it to where it’s needed, fast. This is the power of global collaboration.”

Funding the ACT Accelerator

In another development, heads of state, global health leaders, scientists and the private sector came together at the Paris Peace Forum (11-13 November 2020) to discuss how to meet the urgent funding needs of the ACT Accelerator. New contributions bring the total committed to over US$5.1 billion – but an additional $4.2 billion is needed urgently this year, with a further $23.9 billion required in 2021, if tools are to be deployed across the world as they become available.

With significant advances in research and development by academia, private sector and government initiatives, the ACT Accelerator is on the cusp of securing a way to end the acute phase of the pandemic by deploying the tests, treatments and vaccines the world needs.

Ursula von der Leyen, president of the European Commission reminded delegates that the $28 billion needed to fund the ACT-Accelerator to fulfil its objectives is equivalent to “the same sum the transport sector and the global tourism sector lose in just two days of lockdown”. She added that “there is a very clear message behind it. It’s way better to invest now in the ACT Accelerator and to COVAX – for the distribution in every corner of the world of vaccines – than to struggle longer with all the confinement measures we have suffered during this pandemic.”

Melinda Gates, co-chair of The Bill & Melinda Gates Foundation, said: “Covid-19 has made distinction completely irrelevant. In this pandemic, there’s no difference between helping yourself and helping others. The self-interested thing and the selfless thing are one and the same.”

The urgent funding need of $4.2 billion will save lives, lay the groundwork for mass procurement and delivery of Covid-19 tools around the world, and provide an exit strategy out of this global economic and human crisis by:

  1. Massively expanding testing globally by immediately increasing the number & volumes of new high-quality rapid diagnostic tests and facilitating use in countries with fragile systems;
  2. Transforming treatment to save lives by hugely accelerating the availability and use of dexamethasone and oxygen, and securing production capacities for monoclonal antibodies;
  3. Rolling out mass vaccination by securing vaccines doses now to launch their worldwide rollout for at least 20% of the global population, while quickly investing in further R&D, technology transfer and scale-up of global manufacturing capacity; and
  4. Unblocking bottlenecks to Covid-19 tools supply chain management, logistics and delivery with rapid assessments, integrated delivery plans and key investments in countries with the most fragile systems.

Fully financing the ACT-Accelerator will position the world to fundamentally change the dynamic of the pandemic. Funding gaps mean delays in access to tools in 2021 and the world continuing to rely on non-pharmaceutical interventions like stay-at-home orders and physical distancing as the primary line of defence against the virus.

The ACT Accelerator Commitment Tracker provides details on total commitments to date: access-to-covid-19-tools-tracker

Siemens Healthineers receives CE-mark for rapid SARS-CoV-2 antigen test

Siemens Healthineers has received the CE-mark for their rapid and easy-to-use antigen test for the detection of SARS-CoV-2. The CLINITEST Rapid COVID-19 Antigen Test is a point-of-care cassette test does not require laboratory processing and delivers results in 15 minutes.

The CE marked test, which has been developed and tested by a Siemens Healthineers partner, demonstrated 96.72 % sensitivity and 99.22 % specificity based on a clinical study of 317 subjects. The study was performed using operators with varied credentials at six diverse sites including a hospital, a community clinic, a college campus, and an oncology unit.

There are plans to submit the test for FDA Emergency Use Authorization.

Christoph Pedain, PhD, Head of Point of Care Diagnostics at Siemens Healthineers commented: “There is a great public need for reliable tests that can quickly identify contagious individuals and help to minimize the spread of Covid-19, especially in hightraffic areas and where people commonly congregate.

“With quality at the forefront of decision makers’ criteria to determine test reliability, it was critical the clinical study for this test assessed variable clinical conditions that can be expected when implementing a rapid antigen test. This rapid antigen test makes testing available to more people across a wider variety of settings – particularly in locations that need to test people quickly such as airports or that have limited access to laboratory resources such as schools.”

The CLINITEST Rapid COVID-19 Antigen Test delivers results quickly using the nasopharyngeal swab method. Once a sample is collected, the swab is inserted into a tube with special liquid to extract the target molecule. This liquid is then dispensed onto a test cassette and, in 15 minutes, a positive or negative result is clearly indicated.

Antibody test
Siemens Healthineers also recently announced that their SARS-CoV-2 IgG Antibody Test (sCOVG) has proven to measure neutralizing antibodies and has achieved CE Mark. The test is an close up enhanced version of the assay which became available globally this summer, including in the U.S.

It demonstrates the ability to detect neutralizing antibodies and reports quantitative results measuring the amount of neutralizing antibodies present in a patient’s blood sample.

The company says its SARS-CoV-2 IgG antibody tests are available on one of the largest installed bases of automated immunoassay analysers worldwide, and the largest in the U.S. This includes the Atellica Solution and ADVIA Centaur XP and XPT families of analysers and the Dimension Vista and Dimension EXL systems.