- A full entry package deal contains WHO coverage steerage on the usage of antigen-based speedy diagnostic checks, producer quantity ensures for low and middle-income nations, catalytic funding to help governments to deploy the checks and an preliminary US$50 million procurement fund
- Several speedy, point-of-care antigen checks are being assessed by WHO for Emergency Use Listing (EUL)
- Agreements between the Bill & Melinda Gates Foundation and take a look at producers Abbott and SD Biosensor make accessible modern checks priced at a most of US$5 for low- and middle-income nations (LMICs)
- The Global Fund commits an preliminary US$50 million to allow nations to buy the brand new checks, with the primary orders anticipated to be positioned this week
- Expedited market introduction of those checks in a number of LMICs is being supported by way of the Africa Centres for Disease Control and Prevention (Africa CDC), Unitaid, FIND, CHAI, and their companions
- This is the newest transfer from the Access to COVID-19 Tools (ACT) Accelerator to develop, procure and distribute vital new instruments to combat the pandemic; new checks are urgently wanted to satisfy the massive unmet wants for testing worldwide
A set of agreements to make accessible, for low and middle-income nations, inexpensive, high-quality COVID-19 antigen speedy checks had been at present introduced by the Access to COVID-19 Tools (ACT) Accelerator. Organizations concerned within the milestone settlement embody 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 a part of this complete, end-to-end effort, the Bill & Melinda Gates Foundation has executed separate quantity assure agreements with speedy diagnostic take a look at (RDT) producers Abbott and SD Biosensor. These two preparations will make accessible to LMICs 120 million antigen speedy diagnostic checks (Ag RDTs) – priced at a most of US$5 per unit – over a interval of six months. These checks present leads to 15–30 minutes, reasonably than hours or days, and can allow growth of testing, notably in nations that shouldn’t have intensive laboratory amenities or skilled well being employees to implement molecular (polymerase-chain response or PCR) checks.
The checks developed by Abbott and SD Biosensor are extremely moveable, dependable, and straightforward to manage, making testing attainable in near-person, decentralized healthcare settings. Both firms’ checks are quicker and cheaper than laboratory-based checks, enabling nations to extend the tempo of testing, tracing and treating folks for COVID-19 on the level of care notably in areas with under-resourced well being methods. A lot of different Ag RDTs are at varied phases of improvement and evaluation.
To scale up the Ag RDTs, the Global Fund at present introduced that it has made accessible an preliminary US$50 million from its COVID-19 Response Mechanism to allow nations to buy at the very least 10 million of the brand new speedy checks for LMICs on the assured value, with the primary orders anticipated to be positioned this week by way of the Global Fund’s pooled procurement mechanism.
FIND and WHO are working collectively to speed up applicable use by supporting implementation analysis that may optimize Ag RDT use in a number of LMICs, in keeping with WHO steerage. This contains provision of catalytic volumes of checks to know how Ag RDTs can finest match into well being methods.
Unitaid and Africa CDC will mix sources to provoke the roll out of those checks in as much as 20 nations in Africa beginning in October 2020. This multi-million-dollar intervention, at present present process last sign-off by their Boards, is designed to interact a number of companions energetic within the COVID-19 response in these nations, resembling CHAI, African Society for Laboratory Medicine (ASLM) and native organizations. This will bolster efforts by the African Union’s Partnership to Accelerate COVID-19 Testing (PACT) initiative, launched in August 2020 to mobilize specialists, group employees, provides and different sources to attenuate the impression of the pandemic on the African continent by testing, tracing, and treating COVID-19 instances in a well timed method.
Testing is a vital cornerstone of the COVID-19 response, enabling nations to hint and include the virus now, and to organize for the roll-out of vaccines as soon as accessible. Effective testing methods depend on a portfolio of take a look at varieties that can be utilized in several settings and conditions. While molecular checks began to be rolled out inside a month of the virus being sequenced, these checks are primarily laboratory primarily based, counting on infrastructure and skilled personnel to conduct them. Rapid checks to detect the presence of the virus on the level of care, that are quicker and cheaper, are an important addition to the testing arsenal wanted to include and combat COVID-19.
WHO steerage printed on 11 September 2020 highlights the worth of those checks in areas the place group transmission is widespread and the place nucleic acid amplification-based diagnostic (NAAT) testing is both unavailable or the place take a look at outcomes are considerably delayed. As properly as supporting test-trace-isolate methods, the checks may also help establish or verify new outbreaks, assist outbreak investigations by way of screening; monitor illness developments; and probably take a look at asymptomatic contacts.
The ACT-Accelerator Diagnostics Pillar is co-convened by FIND and the Global Fund, working intently with WHO and over 30 international well being skilled companions to speed up innovation and overcome the technical, monetary, and political obstacles to reaching equitable entry to efficient and well timed testing. Such unprecedented international collaboration has enabled improvement and deployment of the primary WHO EUL-approved Ag RDT inside eight months of the primary identification of the virus. In comparability, it took almost 5 years to develop the primary RDT for HIV. Several extra antigen RDTs for COVID-19 are at present below WHO EUL evaluate. Overall, the ACT-Accelerator Diagnostic Pillar goals to facilitate the availability of 500 million checks to LMICs inside 12 months.
These agreements are vital to fulfil the important thing goal of the ACT-Accelerator: to make sure all nations, no matter revenue, have honest entry to new checks and instruments to combat COVID-19. The distinctive velocity with which the Ag RDT entry package deal has been created demonstrates the breadth of the impression of the ACT-Accelerator initiative, and this and future achievements in testing will complement related milestones anticipated to emerge from the Vaccines and Therapeutics Pillars.
Dr Tedros Adhanom Ghebreyesus, Director General of WHO, stated: “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.”
Mark Suzman, Chief Executive Officer of the Gates Foundation, stated: “Testing is an essential tool in the fight against COVID-19. We are delighted to join a partnership that will help ensure that the latest, high-quality diagnostics do not just go to the highest bidder but will be available at an affordable price to the world’s lower income countries. In addition, all of the actions announced today point to the growing success of the ACT-Accelerator in catalyzing global cooperation for a fair and effective response to this global crisis.”
Dr Iain Barton, Chief Executive Officer of CHAI, stated: “These agreements will help ensure that millions of people in low- and middle-income countries have access to high-quality rapid testing in villages and towns as well as cities. This has the potential to revolutionize government’s ability to respond to the pandemic, enabling quick diagnosis and response to contain localized virus outbreaks before they spread.”
Andrea F. Wainer, Executive Vice President of Abbott’s speedy and molecular diagnostics companies, stated: “Abbott is pleased to bring our Panbio COVID-19 rapid antigen test and Sympheos digital solution to people and health authorities in low- and middle-income countries through this innovative partnership. We have long been committed to making sure our life-changing technologies are affordable and accessible, and for decades have been supporting many of these countries with our rapid tests for malaria, HIV, hepatitis, and other deadly infectious diseases.”
Hyo-Keun Lee, Chief Executive Officer of SD Biosensor, stated: “We, SD Biosensor, are pleased to supply our STANDARD Q COVID-19 rapid antigen tests for people who really need fast and accurate COVID-19 diagnosis. Through this partnership, we will keep striving do our best to provide the best quality of COVID-19 antigen rapid kits for fighting COVID-19.”
Dr John Nkengasong, Director of the Africa CDC, stated: “Antigen tests are an important complement to PCR testing, and are crucial to expand testing capacity throughout Africa. The beauty of antigen testing is that it is fast and gives quick results. It will allow healthcare workers to quickly isolate cases and treat them while tracing their contacts to cut the transmission chain.”
Dr Philippe Duneton, Unitaid’s Executive Director a.i., stated: “Access to these point-of-care rapid tests with be a game changer in the fight against COVID-19. We are working to support countries to rapidly deploy and use these new tests in the best possible way. Today’s news shows what the ACT-A partners working together can deliver in our efforts against the COVID-19 pandemic.”
Dr Carolyn Gomes, Special Advisor for the Board, ProActividad, Jamaica, and Alternate Board Member (Developing Country NGOs), The Global Fund “Ensuring equitable access to rapid diagnostic tests is essential for controlling COVID-19 in all countries and to opening up economies across the world. Ensuring an affordable price is a major step forward. Tests that can be used at the point of care by front-line workers will greatly facilitate community access to testing. To ensure equity in access for those who need it most, there will need to be much greater support of the ACT-Accelerator and the Diagnostics Pillar in particular. Much more money is needed to meet the needs of the most vulnerable.”
Peter Sands, Executive Director of the Global Fund, stated: “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.”
Dr Catharina Boehme, Chief Executive Officer of FIND, stated: “With this Ag RDT package, the ACT-Accelerator partners have secured much-needed tools for LMICs to dramatically increase COVID-19 testing. With the financial support of several countries, we have made great progress, but to ensure we reach all those who need testing and bring the prices down, we urgently need substantial funding from public, philanthropic, and multilateral sources.”
About the ACT-Accelerator
The Access to COVID-19 Tools (ACT) Accelerator, is a brand new, ground-breaking international collaboration to speed up the event manufacturing, and equitable entry to COVID-19 checks, therapies, and vaccines. It was arrange in response to a name 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 will not be a decision-making physique or a brand new group, however works to hurry up collaborative efforts amongst current organizations to finish the pandemic. It is a framework for collaboration that has been designed to deliver key gamers across the desk with the purpose of ending the pandemic as shortly as attainable by way of the accelerated improvement, equitable allocation, and scaled up supply of checks, therapies and vaccines, thereby defending well being methods and restoring societies and economies within the close to time period. It attracts on the expertise of main international well being organizations that are tackling the world’s hardest well being challenges, and who, by working collectively, are capable of unlock new and extra bold outcomes towards COVID-19. Its members share a dedication to make sure all folks have entry to all of the instruments wanted to defeat COVID-19 and to work with unprecedented ranges of partnership to attain it. The ACT-Accelerator has 4 areas of labor: diagnostics, therapeutics, vaccines and the well being system connector. Cross-cutting all of those is the workstream on Access & Allocation.
The Diagnostics Pillar of the ACT-Accelerator is concentrated on making certain that everybody who wants a take a look at can get one. Workstreams span analysis and improvement, market readiness, procurement, and nation preparedness. Achievements so far embody laboratory trainings in partnership with Africa CDC in early February, and a collection of on-line programs deployed inside weeks. Nearly 20 million checks have been procured with the Diagnostics Consortium, making certain diagnostic entry for LMICs and readiness for test-and-treat implementation in these nations. Independent evaluations of antibody checks are additionally being carried out, as high-quality antibody checks are important to know inhabitants immunity for future vaccine roll out.
For details about WHO’s Emergency Use Listing