アフリカなどの途上国では、新型コロナウイルスの検査体制がぜい弱で、感染者の症状の悪化や感染の拡大につながっていると指摘されています。
WHOのテドロス事務局長は28日、スイスのジュネーブで定例の記者会見を開き、感染症対策に取り組む国際的な基金「グローバルファンド」などとともに、今後、途上国などに1億2000万回分の簡易検査キットを配布すると発表しました。
配布される簡易検査キットは、2種類でアメリカと韓国の企業がそれぞれ開発しました。
検査の費用は1回あたり5ドル以下で、15分から30分で信頼できる結果が得られるほか、PCR検査とは異なり、検査を行うための訓練を受けた医療従事者がいない場所でも簡単に行えるということです。
テドロス事務局長は「感染者を早期に把握できれば、治療や隔離、追跡を速やかに行うことができる」と述べ、世界的な検査体制の強化が重要だと強調しました。
簡易検査キットは今後、アフリカや南アメリカをはじめとする世界133の途上国などに配布されることになります。
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WHOのテドロス事務局長は、アボット・ラボラトリーズなど2社(Abbott and SD Biosensor)がビル・メリンダ・ゲイツ財団と、携帯性に優れ使いやすい検査1億2000万回分を、半年間にわたり製造することで合意したと説明した。
韓国の診断キット業者が注目を集めるのは、中東呼吸器症候群(MERS)、エボラ出血熱、新型インフルエンザなどを経験し、ノウハウを蓄積し、迅速な意思決定が可能な博士・教授出身の専門家が会社を率いている点 である。
3月16日現在で食品医薬品安全処から販売許可を得ているのは5社で、うち4社 (Kogene Biotech、Seegene、SolGent、SD Biosensor)が診断キットを大量生産し、国内の需要を満たし、海外にも輸出している。
1回分の価格は現在最大5ドルだが、今後価格が下がる可能性があるという。
テドロス氏は「検査を実施する施設や、検査を行う訓練を受けた医療従事者が不足している地域を中心に検査を拡大することができる」と述べ、この取り組みは検査能力を上げるに当たり不可欠であり、感染が拡大している地域では特に重要になると説明した。
A set of agreements to make
available, for low and middle-income countries, affordable,
high-quality COVID-19 antigen rapid tests
were today announced by the Access to COVID-19 Tools (ACT)
Accelerator. 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 (RDT) producers
Abbott and SD Biosensor. These two arrangements will make
available to LMICs 120 million antigen rapid diagnostic tests (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 near-person, 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 today announced 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, with the first orders expected to be
placed this week through the Global Fund’s pooled procurement
mechanism.
FIND and WHO are working together
to accelerate appropriate use by supporting implementation research
that will optimize Ag RDT use in multiple LMICs, in line with WHO
guidance. This includes provision of catalytic volumes of tests to
understand how Ag RDTs can best fit into health systems.
Unitaid and Africa CDC will
combine resources to initiate the roll out of these tests in up to
20 countries in Africa starting in October 2020. This
multi-million-dollar intervention, currently undergoing final
sign-off by their Boards, is designed to engage multiple partners
active in the COVID-19 response in these countries, such as CHAI,
African Society for Laboratory Medicine (ASLM) and local
organizations. This will bolster efforts by the African Union’s
Partnership to Accelerate COVID-19 Testing (PACT) initiative,
launched in August 2020 to mobilize experts, community workers,
supplies and other resources to minimize the impact of the pandemic
on the African continent by testing, tracing, and treating COVID-19
cases in a timely manner.
Testing is a critical cornerstone
of the COVID-19 response, enabling countries to trace and contain
the virus now, and to prepare for the roll-out of vaccines once
available. Effective testing strategies rely on a portfolio of test
types that can be used in different settings and situations. While
molecular tests started to be rolled out within a month of the virus
being sequenced, these tests are mainly laboratory based, relying on
infrastructure and trained personnel to conduct them. Rapid tests to
detect the presence of the virus at the point of care, which are
faster and cheaper, are a vital addition to the testing arsenal
needed to contain and fight COVID-19.
WHO guidance published on 11
September 2020 highlights the value of these tests in areas where
community transmission is widespread and where nucleic acid
amplification-based diagnostic (NAAT) testing is either unavailable
or where test results are significantly delayed. As well as
supporting test-trace-isolate strategies, the tests can help
identify or confirm new outbreaks, support outbreak investigations
through screening; monitor disease trends; and potentially test
asymptomatic contacts.
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.
These agreements are critical to
fulfil the key objective of the ACT-Accelerator: to ensure all
countries, regardless of income, have fair access to new tests and
tools to fight COVID-19. The exceptional speed with which the Ag RDT
access package has been created demonstrates the breadth of the
impact of the ACT-Accelerator initiative, and this and future
achievements in testing will complement similar milestones
anticipated to emerge from the Vaccines and Therapeutics Pillars.
About the ACT-Accelerator
The Access to COVID-19 Tools
(ACT) Accelerator, is a new, ground-breaking 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 or
a new organization, 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, thereby
protecting health systems and restoring societies and economies in
the near term. It draws on the experience of leading global health
organizations which are tackling the world’s toughest health
challenges, and who, by working together, are able to unlock new and
more ambitious results against COVID-19. Its members share a
commitment to ensure all people have access to all the tools needed
to defeat COVID-19 and to work with unprecedented levels of
partnership to achieve it. 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 Diagnostics Pillar of the ACT-Accelerator is focused on ensuring that everyone who needs a test can get one. Workstreams span research and development, market readiness, procurement, and country preparedness. Achievements to date include laboratory trainings in partnership with Africa CDC in early February, and a suite of online courses deployed within weeks. Nearly 20 million tests have been procured with the Diagnostics Consortium, ensuring diagnostic access for LMICs and readiness for test-and-treat implementation in these countries. Independent evaluations of antibody tests are also being conducted, as high-quality antibody tests are essential to understand population immunity for future vaccine roll out.