serological tests not yet reimbursed in France

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Have I been infected with coronavirus? In terms of serological tests to detect whether a person has encountered Sars-CoV-2, the virus responsible for Covid-19, doctors and pharmacists are amazed by the practices of the Ministry of Health. Expected since last Saturday, legal texts have still not been published to authorize the reimbursement of around thirty serological tests in medical analysis laboratories and to allow pharmacists and general practitioners to practice rapid orientation tests diagnostic on patients. Since the publication of a list of 23 tests, on a website of the Directorate General of Health (DGS), on Thursday evening, May 21, their number has grown slightly to 35 tests, including 27 rapid tests. But for the moment none of them is reimbursed by social security.

A decree and an expected decree for laboratories

Questioned by the Figaro, the DGS ensured that the publication “A decree and a decree in the Official Journal fixing the modalities of the reimbursement of serological tests” was scheduled for Wednesday, May 27 in the morning. But faced with delays that are not explained, this promise was transformed by a publication in these “next days”, without explanation of the new delay. The publication of legal texts to authorize the reimbursement was expected since last Saturday. A catch-up diagnosis may be made in medical analysis laboratories by means of a blood test. This should concern “millions of people”, had recently specified the president of the High authority of health. These are people who have not been able to benefit from a virological test (PCR) since March, patients with an ambiguous medical diagnosis, caregivers in contact with Covid-19 patients and all staff in closed places, such as nursing homes. Prescribed by prescription, this biological act is billed freely, for the moment, from 20 to 40 euros.

A specific order for pharmacies

“I have never seen this in a thirty-year career. The decree published last week in the Official Journal to authorize serological tests refers to a website for the “beta” list of authorized serological tests, it is not very serious! “, laments a doctor biologist. He is surprised that the promised reimbursement has still not been approved by the Ministry of Health.

On Tuesday, May 26, pharmacists are not allowed to perform tests. Those who perform serological tests do an illegal exercise in biology

Carine Wolf-Thal, President of the National Council of the College of Pharmacists.

For pharmacists, the question is even more difficult. Because the DGS promises publication, also in the “next days”, another specific order so that rapid tests can also be carried out in pharmacies or general practitioners’ offices, with the drop of a drop of blood at the fingertip.

However, some pharmacists have already started to carry out rapid tests in their pharmacies. “I don’t understand why the ministry of health has not yet published the text which will authorize pharmacists and certain medical professions to carry out rapid tests of diagnostic orientation? I wrote to the Directorate General for Health last week and got no response “, entrusts to Figaro Carine Wolf-Thal, President of the National Council of the College of Pharmacists. “Until the order is published in the Official Journal, which was still not the case on Wednesday, May 27, pharmacists are not allowed to perform these tests. Those who do serological tests are doing an illegal exercise in biology ”.

»READ ALSO – The reliability of the tests remains to be assessed in Europe and in France

The situation is totally grotesque. The High Health Authority warned on May 18 against the use of self-tests. More than 200 serological tests have already obtained a “CE marking”, a European authorization, but which results from a “self certification” by its manufacturer. Therefore, the people who buy them have no guarantee that these tests are reliable! In addition, they may misinterpret the result. The information provided by these rapid tests is often inaccurate.

“The government must clarify the current situation. We have to get out of the confusion. Pharmacists have the right to sell self-tests but not to perform rapid diagnostic testing “, adds the president of the Council of the College of Pharmacists.

Maybe the “next days” promised by the DGS mean a clarification of the situation towards the end of the week …

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