Questions and answers about the new Roche Corona test: a result in 15 minutes



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Roche is launching a new rapid corona test. Who is it suitable for and how it will work.

Soon also in Switzerland?  A paramedic conducts a rapid crown test in Kashmir, India.

Soon also in Switzerland? A paramedic conducts a rapid crown test in Kashmir, India.

Photo: Farooq Khan (EPA / Keystone)

What is it about?

Swiss pharmaceutical company Roche announced Tuesday the launch of a new corona rapid test. Unlike conventional PCR testing procedures, the test does not require any laboratory infrastructure and must deliver a result within 15 minutes. It will initially be sold in Europe at the end of September. The pharmaceutical giant is also seeking emergency approval in the US The tests are intended to help identify infected people more quickly and use medical capabilities more effectively. (Read here how these tests could help contain the virus.). Thomas Schinecker, head of Roche’s diagnostics division, says it is particularly important to know whether a person has the coronavirus or the flu, especially in the upcoming flu season. Commyoufucking quote.

What kind of test is that?

Roche’s rapid tests are called antigen tests. These do not detect parts of the virus genome (RNA), as has happened so far in many places.meIt is made in the laboratory by polymerase chain reaction (PCR), but only parts of the virus envelope. In the case of the Roche test, it is performed using a strip of paper coated with specific antibodies. If corona antigens are present in sufficient concentration, they bind to antibodies, causing a mark on the test strip within 15 minutes. With standard PCR testing procedures, it usually takes several hours before a result is available. Antigen tests do not require laboratory tests and cantIn can be done relatively easily in a doctor’s office, pharmacy, or even at home.

Who Should Get Tested?

Roche rapid tests act as a support for existing test procedures. People with symptoms compatible with Covid-19, but also asymptomatic people who are or have already been exposed to a higher risk, should be informed about their infectivity at an early stage with the help of the test.

According to one Handbook according to the US Department of Health, rapid tests are most effective in the early stages of infection, when the virus load is highest. Results are less accurate than with PCR tests. To make up for that, I shouldtIn the test results they are compared with other factors, such as symptoms or contact with infected people and, if necessary, another test is performed, Roche writes.

Experts, on the other hand, consider a wide application of such tests absurd. They would be conceivable, for example, in situations where many people were housed for a long time and a safe distance could not be guaranteed, the ETH biologist said. and member of the group of experts “Diagnosis and tests” of the Federal Covid-19 Working Group, Markus stoffel, in front of this newspaper. For example, you could use a test like this before entering a club or before boarding at the airport.

How does such a test work?

The test, like pregnancy tests, works on the so-called lateral flow principle. Will a swab taken from the back of the nasopharynx with a cotton swab. This smear is then applied to a test strip along with a liquid.which removes the swab from the swab and ensures that potentially present antigens can be carried on the strip. After about 15 minutes, the test shows if the antigens are actually present. They are and thus an active infection with the coronavirus is present.

Some rapid tests, like the one at Harvard University, were done for personal use.  However, the Roche test should only be performed by healthcare professionals.

Some rapid tests, like the one at Harvard University, were done for personal use. However, the Roche test should only be performed by healthcare professionals.

Photo: Wyss Institute at Harvard University

No diagnostic device is required, the test can theoretically be done anywhere. Despite its simplicity, it is a domestic use., as required by certain rapid test experts, not provided. “The smear should be done by a medical professional,” explains Roche media spokesman Patrick Barth. On demand.

How much will the test cost?

The main arguments for the tests are, in addition to speed and remereeasy handling, low manufacturing costs. As Harvard epidemiologist Michael Mina said in an article for the university magazine “The Harvard Gazette,” such rapid tests could be produced for less than US $ 1 per unit. Roche will not comment on price on request. Barth Media Spokesperson assures however, dass company doutside so make sure they are not a barrier to entry.

When can I get tested?

Roche announced that it would bring the tests to market at the end of September. From then on, the pharmaceutical giant wants to produce around 40 million units a month. This number should more than double by the end of the year.says in the statement. But even when it will also be widely used in Switzerland is still open.

Roche’s rapid tests were verified for accuracy in India and Brazil, which the pharmaceutical company also relies on for the information. Full validation is available in Switzerland However still out, as Daniel Dauwalder, media spokesman for the Federal Office of Public Health, explains. The consequence: “Rapid tests to detect Covid-19 are not allowed outside of approved laboratories.”

One of these approved laboratories is located at the Institute for Medical Virology at the University of Zurich. The University Hospital Zurich (USZ) has its samples examined there, among other things. The tests can definitely be bought and used here, says Dauwalder. On demand äussert sI the USZ nAlso be careful to use the tests soon. “The USZ has very high standards for Covid-19 testing. It must first be demonstrated whether the rapid tests meet these requirements », He says USZ Communications Officer Katrin Hürlimann. However, keep a close eye on the situation with respect to all innovations.

What do the experts say?

The main point of criticism of these rapid tests is their inaccuracy, especially with regard to their sensitivity. This indicates the percentage of all infected people for whom the test is positive. “Many experts are critical of these tests,” he explains.me ETH Biologist Markus Stoffel. He warns of false security if the tests are too imprecise, but he also believes that meeting the quality requirements also brings advantages. Lab capacities would be saved, for example, and contact would be saved thanks to the faster test resultSimplified tracking (Read here how testing capabilities are working in Switzerland).

Roche places the sensitivity of its test at 96.52 percent, a relatively high value for rapid antigen tests. However, common PCR tests reach 98 to more than 99 percent. Specificity – that is, the proportion of uninfected people who tested negative – is again at a high level of 99.68 percent.

The comparatively lower sensitivity is not a reason not to run the tests anyway, medium Jonas Schmidt-Chanasit of the Bernhard Nocht Institute for Tropical Medicine in Hamburg. The fact that infections are generally overlooked is due to the fact that only a little Virin is in the bodyin. According to the latest findings, this in turn means that those affected could no longer infect anyone. And that’s something quite men crucial, ”says the virologist. “We need tests to show infectivity.”

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