'The poorness of the new coronavirus antibody test is a disaster level,' said the CEO of a major pharmaceutical company, and what is the problem with the antibody test?



Severin Schwan, CEO of Swiss-based global pharmaceutical company

Roche , said, `` It's not worth it, it's almost nothing '' about some of the new coronavirus infection (COVID-19) test kits released so far. It was useless. ' Behind this is the fact that unreliable antibody tests are promising.

'A disaster': Roche CEO's verdict on some COVID-19 antibody tests-Reuters
https://www.reuters.com/article/us-roche-results/a-disaster-roche-ceos-verdict-on-some-covid-19-antibody-tests-idUSKCN2240JS

Roche CEO Blasts Faulty Antibody Tests, Touts Own Product-Bloomberg
https://www.bloomberg.com/news/articles/2020-04-22/roche-ceo-blasts-faulty-virus-tests-while-touting-own-product

Some high-demand Covid-19 blood tests a 'disaster,' says Roche CEO Severin Schwan-San Francisco Business Times
https://www.bizjournals.com/sanfrancisco/news/2020/04/22/covid-coronavirus-serologic-blood-tests-roche.html



When infected with COVID-19,

antibodies against the virus are made in the body, so it is expected that the person who has acquired COVID-19 immunity can be identified by an antibody test for the presence of antibodies. If we can understand the number and proportion of people who have acquired immunity to COVID-19, it will be useful for making policy decisions such as resumption of economic activities and lifting of urban blockade. In the United States, Spain, the United Kingdom, etc., over 100 types of antibody test kits have been commercialized and distributed.

In addition, antibody testing can be performed by a relatively simple method, such as puncturing a fingertip with a needle and collecting a blood sample. It also has the advantage that the time to obtain results is short and the test kit is cheap.

However, Roche's CEO Schwann said in a telephone press conference on April 22 that he announced results for the first quarter of 2020, `` We tested off-the-shelf antibody tests on the market, but the reliability of these test kits It wasn't very satisfying, it was a disaster, and the ethics of the companies that sell these test kits are very questionable, 'he said. did.



Schwan's severe criticism of ready-made antibody test kits is due to 'unreliability.' Mr. Schwan said, 'Any amateur can make an antibody test kit. If I and someone else spend the night, I can develop an antibody test kit in my garage. In other words, the problem is that something that doesn't work as a test kit is actually for sale. '

Schwan isn't the only one questioning the accuracy of antibody testing. Former Secretary-General of the US Food and Drug Administration (FDA) Scott Gottlieb said in a CNBC news show on May 4th: 'If you test positive for an antibody, we recommend that you test again. Frankly speaking, I will receive it three times, 'he said , pointing out the high false positive rate.

On the other hand, antibody tests with high accuracy have also appeared. On May 3, the FDA approved the antibody test ' Elecsys Anti-SARS-CoV-2 ' newly developed by Roche. According to Roche, this antibody test uses blood taken from the veins of the test subjects and detects both two types of antibodies, ' IgM ' and ' IgG ', so the probability of correctly determining negative subjects is high. Is 99.8%, and if positive, it is 100% and reliable. This antibody test drug has been sold to medical institutions and research institutions throughout Japan since May 13th.

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