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Anti-Covid self-tests: is there a risk that positive cases will vanish in nature?

2021-04-09T10:13:37.388Z


The pharmacy sale of these do-it-yourself tests is supposed to start on Monday, April 12, and positive people will be encouraged to do so.


“If I am positive by self-test, of course I will not go out for a PCR test to confirm it!

How many are these French, like Marie, Parisian of 34, to hold this position "out of laziness" or out of fear?

"Many" anticipate the various players in this file that we have contacted.

And there is an urgent need to prepare for it, while the marketing of these anti-Covid tests to perform oneself could begin Monday, April 12, only in pharmacies.

At first glance, these self-tests offer a great promise: allow everyone to self-test alone, at home, and therefore at any time.

No need to queue in front of laboratories or look for a pharmacy on a Sunday, for example.

But "the traceability of self-tests is not guaranteed, thus impacting the evolution of the epidemic or the isolation measures or the search for contact cases", warned the High Authority of Health (HAS) in its opinion. returned on March 16.

Unlike a conventional PCR or antigen sample, this time no one will be responsible for filling in the SI-DEP and Contact Covid databases.

These are used to calculate the various indicators of the epidemic and for "contact tracing" by the Health Insurance.

It is for this reason that the HAS "recommends to the Ministry of Health and to the manufacturers of self-tests to set up the traceability methods most suited to these issues", it was indicated in black and white in its opinion.

Pharmacies mobilized for information

Three days before the start, the strategy is not yet fully official on the side of the Ministry of Health.

But the main recommendation will therefore be to have the positive self-test confirmed by a laboratory test.

This would also make it possible to "have a PCR for screening, or even for sequencing, in order to look for a possible variant", supports Claude-Alexandre Gustave, medical biologist and specialist in immunology.

But it will be impossible to ensure that this is done systematically.

“Honestly, we won't control all of these people.

I think that a lot of people will say to themselves that the best thing to do with a positive self-test is to isolate oneself ”, judge François Blanchecotte, president of the union of biologists.

Well aware of this risk, the Ministry of Health intends to make pharmacists aware of information for their customers.

"The fact of going only through pharmacies makes it possible to ensure that the good gestures to be observed will be well communicated", one supports in the entourage of the Minister of Health, Olivier Véran.

"Chiche", answers Philippe Besset, the president of the Federation of pharmaceutical unions of France.

"Obviously we will do it, we will have to rely on the citizenship and the responsibility of the people," he says.

The idea, blown by the ministry, to offer in some cases an antigen test to be carried out on site rather than leaving with a self-test, finds much less favor in his eyes.

"In the coming weeks, we will already be very busy with vaccination," anticipates the manager, himself a pharmacist in Limoux (Aude).

New packaging

The Ministry of Health and the National Medicines Safety Agency (ANSM) have also discussed a lot in recent weeks with the four manufacturers who have obtained a marketing exemption for their product.

In particular, they were asked to strengthen the prevention messages on the packaging.

"We added, at the request of the ministry, a large sticker representing a diagram with the result of the test (one or two lines) and the instruction to go for a PCR test if we are positive," says Oren Bitton, the commercial director of Biosynex, one of the four manufacturers in question.

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Next to it, a QR code to be scanned will allow you to be redirected to the website of the Ministry of Health with all the available information.

In the absence of “CE” marking for the moment, a label stating that the product is validated by the ANSM has also been added.

Finally, there is now a mention of the portal for reporting possible unwanted items following the test.

The new packaging of the product Biosynex (DR) 

Will all of this be enough to avoid the holes in the racket?

Probably not.

And beyond “tracing”, the incidence rate risks becoming biased if all the positive cases are no longer detected.

“It's the best way to get past the peak of the epidemic,” jokes a doctor from the Ile-de-France region.

“There is a risk and this is the limit of the self-tests.

But they must be considered upstream and in addition to other types of tests, making it possible to find positive people who would never have known otherwise and who will take their precautions not to infect other people, ”defends de his side Oren Bitton, whose products are already distributed in Belgium, the Netherlands and Germany.

A slow start?

The United States has built a more complete system.

“The self-test kit is sold turnkey.

We scan its positive result via a QR code and this allows it to be recorded in the system and to launch the contact tracing ”, indicates Claude-Alexandre Gustave, who imagines that the attending physician could fulfill this function in France by contacting himself health insurance.

But that would add a step and make the procedure more complex.

We can also imagine that the patient contacts his pharmacist who would then fill in SI-DEP afterwards, but "this idea was not retained because we feared a duplication if the person did more in PCR test", indicates Philippe Besset.

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Biosynex plans to deliver "4 or 5 million self-tests" to pharmacies in April in France, and 6,000 pharmacies have already placed pre-orders.

“There are 10 boxes of 5 self-tests for each of them” initially, indicates Oren Bitton, who expects the final go by Monday (provided that this date is held).

In pharmacies, the price could be around 7 to 8 euros per unit, and around 30 euros for the box of five.

“It will probably be standardized everywhere in France, with full reimbursement for certain categories,” anticipates Philippe Besset, who has a series of meetings on this subject.

Despite all this, "quite honestly, I do not think that everyone will rush to self-tests", wants to believe a government adviser.

Not so sure.

In Germany, where these kits are also sold in supermarkets, some stores were taken by storm from the first hours.

Source: leparis

All life articles on 2021-04-09

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