As Covid-19 Testing Moves Center Stage, U.S. and U.K. Approaches Differ

Covid-19 is a testing requirement for all new medicines across the European Union. It has become a touchstone for drug manufacturers, as the European Medicines Agency (EMA) has placed a strong emphasis on this requirement within its new drug registration process. The U.S. is following a different path, with the FDA placing an emphasis on outcomes research.

In the U.S., the FDA is recommending that Covid-19 testing be performed on a case-by-case basis, while the U.K.’s MHRA recommends that all individuals be tested before treatment is started. The U.K.’s approach is more lenient, but Covid-19 is difficult to test for, and the U.S.’s “one size fits all” approach may be better for overall patient safety.

LONDON – While successful vaccination campaigns beat Covid-19 in many Western countries, health experts say faster, smarter tests are the way to control the disease while easing the constraints of daily life.

Rapid tests are now available in pharmacies and online in the United States, but there are concerns that they are too expensive for frequent use. The genetic sequencing needed to detect potentially dangerous variants of the virus is uneven, with some states being monitored much more frequently than others.

In contrast, in the UK simple test kits are provided free of charge to homes and businesses on request and laboratories carry out sequencing of thousands of viral genomes every week. After the discovery of clusters of varicose veins, so-called rapid tests began to spread in London, Birmingham and Manchester.

The strategy highlights what scientists believe will be a critical element of the next phase of the pandemic for countries where vaccination is already well advanced: Simple and affordable tests to prevent new infections, and a genetic search for interfering mutants that may find a weak spot in our immunological armour.

We are entering a new phase of this pandemic and the role of testing, sequencing and all the different methods of monitoring the virus is certainly changing in terms of the role it plays in keeping society safe and controlling this pandemic, said Michael Mina, associate professor of epidemiology at Harvard’s Kennedy School of Public Health.

The incidence of CVD is increasing worldwide, fueled by severe epidemics in India and Latin America. Since the beginning of the pandemic, more than 150 million cases have been reported worldwide and more than 3 million deaths attributed to the virus.

Covid-19 test kits are on the shelf at the Manhattan CVS store.

Photo:

Gabby Jones for The Wall Street Journal

However, in some developed countries around the world, including the United States, the epidemic appears to be declining as more people are protected from infection and disease by vaccination.

Forty-four percent of the U.S. population has received at least one dose of the vaccine, according to the Centers for Disease Control and Prevention. In the UK about half the population has been vaccinated and in the EU about a quarter.

Even in countries where vaccination is widespread, epidemiologists do not expect the virus to disappear completely. By traveling internationally, it can continue to spread as long as it challenges developing countries. The pathogen can also be found in unvaccinated groups, such as B. children, and survive in communities unable or unwilling to protect themselves.

This means that countries should not let their guard down, scientists say. Monitoring of the virus and of any new infectious mutations will be important, both to prevent further outbreaks and to refine vaccines if repeated vaccinations are required.

Vaccination won’t eradicate them anytime soon, even if it helps calm the situation. That’s why testing will continue to be important, says Gigi Gronwall, an immunologist and associate professor at the Johns Hopkins Bloomberg School of Public Health.

Vaccination site in Derby, England. About half of the UK population has been vaccinated.

Photo:

Oli Scharff/Agence France-Presse/Getty Images

The United Kingdom, which had the highest number of deaths from the virus in Europe, steadily increased its testing capacity during the pandemic. UK laboratories can process around 650,000 Covid 19 tests per day, an increase of 40% in the last six months.

The authorities consider that mass testing and vaccination are essential to reduce the risk of new epidemics and they are reintroducing strict rules on social delimitation.

The government is looking for ways to put the tests in the hands of citizens to make testing for the virus easy and common. Anyone with symptoms can order a PCR test – the global standard test for Covid-19 – by mail and have it done at home, and receive the results by text or email a few days after they are sent to the lab.

Since last month, households in the UK have also been able to order free boxes of Covid 19 tests for home delivery, which provide results within minutes. Test results are entered online, allowing health officials to detect infections and order follow-up tests. Schools and companies use these so-called lateral flow tests to quickly detect possible infections in pupils and staff.

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These tests are less accurate than PCR tests, and this approach has been criticized in some quarters for the risk of false results. However, many public health experts say the tests are effective in identifying the most infectious people, alerting potential carriers even if they have no symptoms, and reducing the chances of the virus spreading.

Aside from the cost, some health experts are concerned that access to these tests for U.S. citizens is complicated by various state and local regulations related to the difficulty of gaining approval to sell them as health products.

The UK is approaching this pandemic as a public health issue, says Dr Mina.

According to data from Oxford University’s Our World in Data project, around 16 tests per 1,000 people currently take place in the UK every day.

By comparison, there are three cases per 1,000 people in the United States, although the U.S. figures are based solely on PCR test results from laboratories in the country.

As highly transmissible variants of coronavirus spread around the world, scientists are trying to understand why these new versions of the virus are spreading faster and what this may mean for vaccination efforts. New research suggests that an advanced protein that gives the coronavirus its distinctive shape may be the key. Illustration: Nick Collingwood/WSJ

The United States has stepped up genetic surveillance of the virus to identify variants and ranks second after the United Kingdom in the number of genomes submitted to Gisaid, a global database that allows scientists around the world to discover new mutations and track the variants they carry. But most sequencing in the United States takes place in large cities and around densely populated states.

Sequencing will become even more important as we move into an era where most of us are immune, said Dr. G. G.

Sharon Peacock,

Professor of Public Health and Executive Director of the Covid-19 Genomics Consortium in the UK, an alliance of laboratories and universities that conducts tens of thousands of genetic tests on virus samples each week.

Even the UK lags behind other countries in the percentage of cases that are actually sequenced and distributed. In Denmark, one fifth of Covid 19 cases have been sequenced. Australia and New Zealand analyzed and shared half of their data – even though they had much less.

Scientists say the ability of countries to sequence cases varies widely, which could create gaps in global surveillance of hot spots like India.

Email Jason Douglas at jason.douglas@wsj.com.

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