Nigeria develops new Covid-19 test kit

The news of the breakthrough came just as it was gathered that the number of people killed worldwide by the COVID-19 pandemic had exceeded one million, with experts warning that it might double before a vaccine was found.

According to a statement issued by WHO, the rapid test would enable expansion of testing, particularly in countries without extensive laboratories or trained health workers to implement molecular (polymerase-chain reaction or PCR) tests, which costs about N50,000.

The world body said the Antigen Rapid Diagnostic Tests (Ag RDTs) developed by Abbott and SD Biosensor are highly portable, reliable, and easy to administer, making testing possible in near-person, decentralised healthcare settings. According to the statement, the Bill & Melinda Gates Foundation has executed separate volume guarantee agreements with the Ag RDT producers, Abbott and SD Biosensor. These two arrangements will make available to Low and Medium Income Countries (LMICs) 120 million Ag RDTs, priced at a maximum of $5 per unit over a period of six months.

Also, the Access to COVID-19 Tools (ACT) Accelerator, yesterday, announced a set of agreements to make available for LMICs the Ag RDTs.

The 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.

Organisations 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 WHO.

Before now, the Nigeria Centre for Disease Control (NCDC), the Federal Ministry of Health (FMoH) and the Presidential Task Force on COVID-19 had been opposed to rapid diagnostic tests, which results they said were not 100 per cent reliable. But it is hoped that with the WHO announcement, the country will be able to carry out more tests.

The Guardian had reported that the ‘non-approval’ of rapid test kits by the FMoH and the NCDC amid the low capacity of the country to test for COVID-19 might be fuelling a black market for the devices.

Investigation revealed that Nigeria had tested only 0.054 per cent of its population of 200 million. Latest figures (Tuesday, September 29) from the NCDC shows that only 108,355 samples (persons) have been tested in a country of about 200 million people, with 58,460 confirmed cases. For the country to reach one per cent of the population with COVID-19 test, the NCDC would have to test two million citizens.

The Director General of NCDC, Dr. Chikwe Ihekweazu, and the Minister of Health, Dr. Osagie Ehanire, could not be reached for comments at press time. But Ihekweazu said “The sale and commercial use of rapid test kits for COVID-19 is against our current policy and guidelines. These rapid test kits do not meet the required standards for sensitivity and specificity and can produce false positive and false negative results.”

Similarly, Ehanire had said results of rapid test kits were not reliable. Ehanire said people were free to access the kits but he could not vouch for the reliability of the results. According to him, the results could only act as a guide and such people would have to do a confirmatory PCR test to be sure of the result.

But a virologist/vaccinologist and Chief Executive Officer (CEO) of Innovative Biotech, Keffi, Nasarawa State, and Innovative Biotech, United States of America (USA), Dr. Simon Agwale, told a source that the absence of rapid test kits in Nigeria portended danger. He called for an immediate deployment of test kits across Nigeria for easy detection of newest contacts.

Agwale, a former researcher at the University of Jos, National Institute for Pharmaceutical Research and Development (NIPRD) Abuja, said: “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.”

Meanwhile, the rapid kits, it has been gathered, work in a similar way as pregnancy test. They display two blue lines to indicate positive for COVID-19. They work by taking a nasal swab and inserting the sample into a cartridge that looks for antigens – or proteins found on the surface of the virus. They differ from the current nasal/throat swabs and finger prick tests because they do not need a lab to produce results.

WHO, last week, approved the tests for emergency use.To scale up the Ag RDTs, the Global Fund, yesterday, announced it had made available an initial $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 optimise 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.

Also, Unitaid and Africa CDC will combine resources to initiate the rollout of the 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.

WHO guidance published on September 11, 2020 highlighted the value of the 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.

Director General of WHO, Dr. Tedros Ghebreyesus, said: “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 critical tool for governments as they look to reopen economies and ultimately save both lives and livelihoods.”

Chief Executive Officer of the Gates Foundation, Mark Suzman, said: “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 catalysing global cooperation for a fair and effective response to this global crisis.”

Chief Executive Officer of CHAI, Dr. Iain Barton, said: “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 revolutionise government’s ability to respond to the pandemic, enabling quick diagnosis and response to contain localised virus outbreaks before they spread.”

ACCORDING to data from John Hopkins University, United States, the death toll from coronavirus now stands at 1,000,555.Director of the Johns Hopkins Center for Health Security, which aims to protect people’s health from epidemics and disasters, Tom Inglesby, said: “This is a very serious global event and a lot of people were going to get sick and many of them were going to die, but it did not need to be nearly this bad.”

Head of WHO’s emergencies programme, Dr. Mike Ryan, said the prospect of two million global deaths from COVID-19 is “certainly unimaginable … but it is not impossible. If we look at losing a million people in nine months, and then we just look at the realities of getting a vaccine out there in the next nine months, it is a big task for everyone involved.”

Chief science officer at the WHO, Dr. Soumya Swaminathan, warned that it could be 2022 before people can begin thinking about returning to “pre-COVID” life.