Genrui Antigen tests retired in various European Countries

An excellent example of why the medical device and diagnostic sectors are so highly regulated can be seen in the recent retirement of the Genrui Antigen tests.

Ireland was the first country to retire the tests after a high false positive count. Spain quickly followed suite.

Unfortunately, Germany has continued to sell the tests from the chinese manufacturer Genrui despite thousands of complaints about false positives already in Autumn 2021.

According to the investigation of Zeit.de, it appears that the tests were probably not tested against cross reactions to some common bacteria. This kind of shameful quality deficit also doesn’t show in the few comparison studies on antigen tests authorised for sale in the EU.

It is to be noted, that the only evidence required until now for an authorisation to sell COVID antigen tests comes from the manufacturer itself. It is a welcome development that this is going to change soon.

I suffered a false positive myself, like many thousand of other europeans, when I used a few of these tests. We used four of them, and two were false-positives!

Do you know that sinking feeling, when the second line at the “T” starts to appear?

This lead to postponement of a family meet-up, an expensive, improvised, trip to get home ASAP, and a few days of quarantine before I was certain of the false positive.

One can only imagine the total economic and emotional costs of the thousands of false positives that these tests have produced.

In the case of Germany, these tests were mandated in Schools, causing stress and trauma to innumerable children and their families that had to put everything aside in order to organise quarantine and negative PCR tests. In my opinion, this should result in the companies responsible (Genrui Biotech Inc and Lotus NL BV) from being banned from doing buisness in the EU.

Although this is a scandal, this is not a reason to write off Antigen Tests in general. When it comes to medical and diagnostic technology, not all manufacturers are the same. There are huge differences, and doing things right requires more effort than quick and dirty.

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By Pablo Rohrssen

Pablo Rohrssen is an Engineer and Entrepreneur. He enjoys creating meaningful products with a positive impact. Based between Germany and Spain, he's been helping companies develop new products since even before graduating in 2013. Before VIDAPRO, he founded a successful web portal on Sustainability & Design, a Professional Association, a Freelance business and a start-up for manufacturing and developing solar PV gensets.

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