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Sunday, 10 May 2020 - 09:45

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Government poised to clamp down on coronavirus test providers

With reporting by Jamie de Geir and Zack Newmark.

Companies that sell self-testing kits to determine whether or not a person has Covid-19 antibodies will face scrutiny and oversight from several Dutch governmental offices. None of the rapid test kits checked by the government have met reliability standards, the Health Ministry said, and informing a patient that they have the antibodies can make the global health crisis worse, as it is still unclear whether or not someone can get Covid-19 more than once.

The rapid self-tests are supposed to be able to provide a fast result when checking a person's blood for antibodies. They are one form of serological test on the market, as opposed to polymerase chain reaction (PCR) tests, which use mucus samples collected from the patient by cotton swab to determine if the patient has an active Covid-19 infection.

"I would like to emphasize that the sale of such corona rapid tests to consumers for home use is not allowed," said Health Minister Hugo de Jonge in an update to Parliament last week. According to the Health and Youth Care Inspectorate (IGJ), the body that supervises the quality, safety and accessibility of health care in the Netherlands, providers of rapid self-testing will face scrutiny in the Netherlands.

"We monitor testing and those who offer it. We have a message on our website stating that self-testing is prohibited. If we are notified about a company that is selling unreliable tests, then we are going to investigate them," an IGJ spokesperson told NL Times last week. "I cannot say which or how many companies [are under investigation] since that differs day-by-day. Today it might be 9 and then tomorrow might be 15."

The investigations were confirmed by the Ministry of Health, Welfare and Sport, which overseas the IGJ. "The IGJ actively monitors test providers and enforces them if necessary. They are working together with [tax office inspectorate] FIOD and the Public Prosecution Service" in order to achieve this, the Ministry told NL Times.

On Wednesday, Apeldoorn-based biotechnology company Inzek had sold over 1.5 million unreliable rapid Covid-19 tests. The company was marketing the items, produced in China, as being "Dutch-made", according to a report in Trouw. Inzet denied that their tests are unreliable.

However, public health agency RIVM pointed out that none of 16 rapid self-tests has hit the threshold for accuracy required in the Netherlands. "We have looked at all kinds of tests and what we see is that none of those tests are suitable. Usually they are serological tests. These tests are not suitable for diagnostics at an individual level," a spokesperson from the RIVM explained to NL Times.

Aside from that, Minister De Jonge said the team advising the government on serological tests also wants to prevent giving people a false sense of security. "It is currently unknown what the link is between having antibodies after infection and the degree and duration of (complete) protection against re-infection," he said in his update to Parliament.

He said it could be "dangerous" for the person tested, and for society as a whole, to suggest that they can break the social distancing rules if their test provides a positive result.

"The question is why would you want to know?" the RIVM spokesperson asked rhetorically. "If you have health complaints you still have to stay at home; Moreover the most important test is the PCR and that has to be done in a specialized lab," the spokesperson said, referring to the mucus swab test used to determine if someone has an active infection.

For the time being, the RIVM recommends that people stay clear of rapid self-testing, and continue to report their health complaints by phone to their family doctor. The government has said it would further expand availability of PCR tests so that more people with symptoms can get tested for Covid-19.

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