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Coronavirus Testing: Battle to Track Pandemic

 


The “test, test, test” obligation has been the slogan of the coronavirus pandemic since last month, Tedros Adhanomge Gebreessas, head of the World Health Organization, said: But simple goals continue to circumvent even the richest countries struggling to track the spread of the virus among the population.

Germany and South Korea have been leading large-scale test rollouts, while the United Kingdom and the United States have lagged behind. The greater the delay, the longer the uncertainty about the size of the virus threat. As diagnostic cravings increase, test kits are rejected and government mounts become impatient, examining available technologies, their potential and limitations.

What tests are available for coronavirus infection?

There are two main types. The first is an antigen test that detects the presence or absence of new coronaviruses that cause Covid-19 disease. The other is an antibody test, which looks for an immune response and looks for signs of someone having been infected in the past.

Since Chinese scientists released the complete genetic code of the virus (formally known as Sars-CoV-2) in mid-January, laboratories anywhere in the world have used antigen testing. Was able to identify that gene from patient samples. They use a procedure called PCR that has been standard practice in laboratories for 30 years.

PCR samples are taken from various parts of the patient. The simplest is a nasal swab that is often taken from the nose. The back of the throat is another option. For hospitalized patients, a sample of the lower respiratory tract may provide the best results. Antigen testing reveals if anyone is currently infected and can therefore pass Covid-19 to others.

Diagram illustrating the two main coronavirus testing processes

In contrast, antibody (or serological) tests work on blood samples to detect immunity given by a previous infection. The test kit uses proteins from the virus as an “adhesive” to capture antibodies present in the blood, said Eleanor Riley, a professor of immunology at the University of Edinburgh.

Pricking your finger provides enough blood to detect the two antibodies to Sars-CoV-2. The first IgM antibodies are short-lived and may indicate that the virus is still present. They usually disappear a few weeks after infection. Instead, the second most durable type of IgG antibody emerges. No one knows how long these will last and provide resistance to reinfection. It can range from months to years.

Antibody testing has been prioritized by governments, including the United Kingdom and Germany, because it is essential to inform individuals whether society can safely return to mixing without passing or picking up the infection. When performed on a representative sample of the population, they also answer important epidemiological questions, such as how many people have been infected mildly or asymptomatically.

When development is complete, antibody tests will provide faster results than traditional PCR tests and should take minutes instead of hours, but much faster antigen kits are under development.

Who performs the test?

When health officials began to realize that the outbreak of coronaviruses could be a global threat, they went to government laboratories, such as the United States Centers for Disease Control and Prevention (CDC) and public health England-run laboratories. We started developing tests. Extensive experience using PCR technology For diagnostics.

Traditionally, antigen diagnostics have been performed primarily in the public sector, with private companies providing test components such as chemical reagents and swabs for patient samples, but some are lacking. However, in the last few weeks, there has been a huge mobilization of private resources as companies around the world enter a rapidly expanding market and deploy automated PCR kits that process samples much faster than traditional labs. did.

According to James Gill, a clinical lecturer at Warwick Medical School, “creating a new antigen test is relatively easy, because PCR tests are a small addition to existing tests.”

However, antibody tests need to be created from scratch, which takes time to develop. “We need to physically draw a patient’s blood, find antibodies (smaller than the virus) in the blood, create a lab-reproducible antibody, and create a reagent test that reacts in the presence of that antibody. Yes, Dr. Gil said.

Although the private sector has played a major role in developing and manufacturing antibody tests, its products still need to be validated by public health authorities before use.

The presence of Chinese companies was outstanding in their efforts to boost the supply of both types of testing. Of the 202 companies worldwide that produce commercialized Covid-19 test kits, 92 have occurred in China, with the outbreak in China, and a thriving innovative medical technology sector.

Chinese companies are the mainstream manufacturer of coronavirus test kits. Graph showing the number of companies and institutions producing commercialized Covid-19 test kits. * Number of companies that reported their work on product testing to Find. FT has not validated the test.

According to data from the Foundation for Innovative New Diagnostics (Find), Geneva-based not-for-profit organization that tracks product development and the 29th largest coronavirus testing company in the United States.

The Find list is not exhaustive and does not include the major players who are not seeking appearances. Among them is Hologic registered on NASDAQ. In that test, the US Food and Drug Administration has granted emergency use.

In addition to traditional antibody and antigen testing, researchers at universities and biotechnology companies are developing new and imaginative diagnostic techniques. For example, Crispr, a gene editing technology that has swept the biotechnology world, can recognize and cut out specific Sars-CoV-2 gene sequences. This can be identified by a change in color.

How fast is the test rollout?

Very uneven—not fast enough in many countries. Although there is no official centralized database, Find reconciles data showing that more than 4.9 million tests have been performed worldwide by March 29.

South Korea, the country that first tested Covid-19 on a large scale, has performed 394,000 so far (equivalent to 770 per 100,000 people). In Iceland, 4,160 tests were performed per 100,000 tests.

United States very Late to start, The first test in CDC did not work, and I had to start over to create a new test. It took some time before other labs could test Covid-19. But in the past two weeks, the United States has launched tests rapidly.

Among the larger European countries, the champion appears to be Germany, and public health officials estimate that the lab performs 500,000 coronavirus tests weekly. Official data has not yet confirmed that number, but suggests that test capacity has grown rapidly in recent weeks. Germany’s distributed testing and laboratory infrastructure means that work is performed not only in hospitals and physicians, but also in special drive-in stations.

Manufacturers are ready to provide millions of antibody tests worldwide, but health and regulatory authorities are still evaluating their accuracy before allowing them to be widely deployed. Last week, UK Secretary of Health Matt Hancock announced that the country had ordered 3.5m antibody test kits from various manufacturers.

How reliable is the test?

PCR tests are very accurate if performed carefully by an experienced technician in a well-equipped lab. Andrew Preston, a leader in microbial pathogenesis at Bath University, said that there are few false positives because it specifically detects genes found only in the Sars-CoV-2 virus.

False negatives-falsely indicating that someone is not infected-is more problematic. Often this is due to problems with the collection and processing of patient samples. For other viruses, a false negative rate of 10% is widely accepted and can be as high as 30%. Therefore, PCR tests were “used more frequently to confirm infection than to completely identify someone,” said Dr. Gil of Warwick Medical College.

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Editor’s note

The Financial Times reads the news of major coronaviruses for free and keeps everyone up to date. Find the latest here.

The accuracy and reliability of new antibody tests are not known until they are verified and technicians have more operational experience.

Spanish Ministry of Health last week Withdraw 8,000 Chinese test kits Worried about incorrect results, they were sent to the local government in Madrid. However, manufacturer Shenzhen BioEasy says that the problem may be due to incorrect sample collection or product use.

Dr. Preston said: “If you need both high-quality kits and properly trained staff, increasing test capacity quickly and on a large scale is not easy.”

Additional reports by Donato Paolo Mancini and Tobias Buck

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