The breakthrough that could halt the pandemic, even before a vaccine

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Imagine a self-administered coronavirus test, done at home, with results available in minutes, instead of the days or sometimes weeks people are currently waiting.

Health experts believe this kind of affordable and rapid self-testing — similar to tests detecting pregnancy or HIV — could change the course of the pandemic until vaccines become available.

Quick tests and results coupled with effective quarantine and contact tracing can stop onward spread, said Joseph Fitchett, medical director at U.K.-based diagnostics company Mologic, which is working on a self-test aimed at poor countries. One of the company’s co-founders, Paul Davis, was the originator of the Clearblue pregnancy test. “They act — if you like — like a vaccine,” Fitchett said.

From Africa to North America, countries are still struggling to expand testing and turn the results around quickly. The current standard nasal swab test requires trained health care and lab professionals to run it. Results can take weeks to come back, leaving people uncertain of their status and potentially free to infect many others while waiting.

It took 40 years to convert the idea of HIV self-tests into a widely available test. But despite false starts — U.K. Prime Minister Boris Johnson said in April such tests would be available within weeks — the coronavirus version of the technology could be ready for production by the end of the year.

A friendlier test technique

The quality of self-tests is defined by both the accuracy of the test and how easy it is for regular people to use it, said Emma Hannay of the Geneva-based Foundation for Innovative New Diagnostics (FIND). Hannay is leading a partnership on coronavirus diagnostics as part of a new global collaboration that brings together numerous organizations, including the World Health Organization.

At-home tests need to be simpler than a long nasal swab, said Mara Aspinall, a professor at Arizona State University and managing director of BlueStone Venture Partners, a venture fund investing in life sciences technology companies in the U.S. Southwest. That could be a sample from the nose tip, or via saliva, which is the type Mologic is working on.

In the Mologic test, people brush their gums to produce a sample, which then goes into a capsule where the viral material is extracted and inactivated. The fluid can then be dripped onto something that looks like a pregnancy test, with the result available a few minutes later. One line displayed on a reader means the test is negative, two lines means it’s positive, according to Fitchett.

Mologic is now working to improve different prototypes for its self-test that could go into mass production by May 2021, Fitchett said. The company has received support from Wellcome Trust, the Bill and Melinda Gates Foundation and U.K. Aid to offset the cost of research and development and make the test available at cost for poor countries, he said.

Licensing self-tests may prove a bigger hurdle than creating them

Perfecting the technology behind the tests is only the first step towards making them widely available. Getting regulators around the world to license them and then ensuring they are manufactured in high enough numbers to be widely available may be bigger hurdles, said Hannay of FIND.

The WHO’s rapid diagnostic test standard requires the test to correctly identify at least 70 percent of the people who have the virus. And while that is lower than the 95 percent rate achieved by the standard nasal test known as PCR, which must be administered by medical professionals, the self-tests could catch infected people more quickly, the experts argue.

“From a societal point of view, even at 75, 80, 85 percent sensitive, you are taking the vast majority of infectious people out of circulation,” Aspinall said.

But Jesus Rueda Rodriguez, director of international affairs at MedTech Europe, a European medical devices industry lobby, is skeptical that self-testing will be widely available in the near future.

“The regulatory process for placing a Covid-19 self-test on the market is more tightly controlled and requires validation with lay users, which is a time-consuming process — usually taking up to six months under normal circumstances, on top of the usual development cycle,” he said.

Europe so far has not been welcoming to the idea of self-tests, with countries like Finland, Sweden and Ireland warning against their use in the spring.

Françoise Schlemmer, the director of Team-NB, which represents certifiers of medical devices in Europe, said some of them will not accept applications for self-tests at the moment.

Tests for everybody who wants a test

Manufacturing enough self-tests for all those who want them is also a challenge — and it needs to happen even before they win validation.

Fitchett of Mologic says the company is willing to show others how they can manufacture their tests. The company is working with the Institut Pasteur in Dakar, Senegal, to scale up production and plans to do the same with other partners in Asia, he said.

In the U.S., some states have banded together to purchase rapid antigen tests, which still need to be administered by professionals, but are quicker to give results than the standard PCR tests.

In the same way the U.S., U.K., Canada and European governments have pre-ordered vaccines, the group of states could put in orders for self-tests to give manufacturers confidence that “once they build it, they will come,” Aspinall said.

“We need to take back control from the virus and we need to do that through tests that are fast,” she said.

COVID VACCINE RACE LATEST

Would you take the Russian vaccine? Philippines president Rodrigo Duterte said he was ready to get it, then had a change of heart. The West’s distrust of the vaccine, meanwhile, is as much about geopolitics as it is about science, the Financial Times’ Moscow bureau chief argues: “Moscow’s Gamalaya Research Institute of Epidemiology and Microbiology, which developed the vaccine, has worked with adenoviruses since the 1980s, and based Sputnik V on its own internationally approved Ebola vaccine.”

New pre-orders: The Swiss and U.S. governments have signed deals to get Moderna’s vaccine if it proves safe and effective, while the EU struck a deal with Johnson & Johnson.

GLOBAL HEALTH SNAPSHOTS

Developing countries struggle: While some rich countries have seen high peaks and valleys in their coronavirus caseloads, many developing countries are struggling with “a long, deadly plateau that is stretching for months,” the Wall Street Journal reported. Nine of the 10 countries with the highest number of Covid-19 cases globally are in the developing world.

Africa: Nigeria received 200 ventilators from the U.S., following a promise made by President Donald Trump in April. But that hasn’t solved their problems: Sub-Saharan hospitals are dependent on costly oxygen from multinational suppliers. As Covid-19 spreads, doctors are being forced to make terrible choices, The Guardian reported.

Americas: A fear of hospitals is leading many Mexicans to delay treatment for coronavirus until it’s too late. El Salvador plans to give immunity certificates to people who have recovered from Covid-19 and employ them to deliver medical kits and food aid to people affected by the pandemic.

Asia-Pacific: Polio vaccination campaigns have restarted in Afghanistan and Pakistan after a Covid-19 hiatus. New Zealand put Auckland in lockdown after reporting the first case of coronavirus community transmission in 102 days.

Europe: Spain is again grappling with Europe’s worst virus infection rate. Its Galicia region has now banned smoking outside if distancing cannot be guaranteed, amid fears that exhaled cigarette smoke or vapor can carry the virus.

WHO: Germany and France quit G7-level talks over how to reform the World Health Organization because they didn’t see the value of the U.S. leading that effort — and also didn’t like a paper laying out the changes the Americans were pushing for. The breakdown in talks proves Trump was right about the need to reform international organizations, a senior administration official told POLITICO.

Source: https://www.politico.com/news/2020/08/14/the-breakthrough-that-could-halt-the-pandemic-even-before-a-vaccine-395179
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