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The Basel-based pharmaceutical company Roche announced it two weeks ago, it is now pending approval: the new antibody test for the detection of people who have been infected with the coronavirus. Approval from the American Food and Drug Administration (FDA) is required. Approval is within reach, as Roche SonntagsBlick confirms: “We look forward to authorization in the coming days.”
The blood plasma test detects the antibodies that the human body has generated after infection with the coronavirus. That makes it a coveted product worldwide. Because: With a corona infection there is no typical course of the disease. This is why many people have unknowingly had an infection.
Predictable normalization time.
“The test can be used to determine how many people actually had contact with the virus in the first wave,” says Andreas Cerny, (64), a virologist at the Corona Moncucco referral hospital in Lugano TI. Then questions like whether children can barely get infected can also be clarified. “At the same time, we can determine how far we are from so-called collective immunity.” It is the condition for a complete normalization of social life.
However, a positive test result does not mean a guarantee of immunity. “The test shows whether he was in contact with the virus,” says epidemiologist Marcel Tanner (67) of the Swiss Institute for Tropical and Public Health in Basel. “However, it does not show whether you are immune to a new infection.” To do this, it must be verified whether the antibodies can also neutralize the virus. “However, there is still a lack of knowledge in this area,” says virologist Cerny. “There is not enough data yet.”
Many tests are unreliable
There are already 80 different antibody tests in circulation worldwide. But many of them are not reliable. “This is because they were developed using samples from only a few, sometimes only 50 patients,” says Michael Nawrath (57), a pharmaceutical analyst at Zürcher Kantonalbank. “The new Roche test, however, is based on thousands of patient samples.
It is very reliable and shows a sensitivity of more than 95 percent and a specificity of more than 99 percent. ” What he means by this: Roche’s Elecsys Anti-Sars CoV-2 test detects 95 out of 100 cases that actually had a Covid infection. And it identifies 99 percent of those who have never been in contact with the virus.
Good business for Roche
The Roche test is supplied in the form of test kits and can only be performed on devices from the pharmaceutical giant. There are 40,000 of them in laboratories and hospitals worldwide. Unit price: two million francs. Analyst Nawrath: “Devices pay for themselves quickly. But of course Roche is already doing business with the test kits.
Given the global shortage, disputes over allocations are inevitable. “At the beginning it will be difficult to get tested,” says Nawrath. “The demand is great.”
That should also apply to Roche shares in the coming days.