Available in pharmacies, self-tests for Covid-19 will no longer be recognized as proof of the health pass from October 15, announces the Ministry of Health. And whether they are supervised or not. How much does it cost ? How to do it ? For who then? Instructions for use in pictures.
[Mise à jour le lundi 11 octobre à 18h37] Since April 12, 2021, it is possible to buy in pharmacy from antigenic self-tests by nasal swab to screen for Covid-19. These over-the-counter self-tests and used privately are not not reimbursed by Social Security. Starting the October 15, the self-tests carried out under supervision a health professional will no longer be recognized as proof for the health pass, inform the Ministry of Health October 8. This system had been deployed temporarily during the summer, in order to support the extension of the use of the health pass. Self-tests performed without supervision remain accessible for individual monitoring but will still not give access to the health pass. The self-tests can be carried out in addition to the tests already available before a meeting with relatives or as part of access to activities in a confined space: restoration, movie theater, live shows … The self-tests are not allowed to travel. What is the reliability self-tests? What is the interest in the detection of SARS-CoV-2? Where can I buy it? Are they reimbursed? Info to date.
The self-test is a screening test including the levy (nasal and non nasopharyngeal therefore shallower), the realization and the interpretation are carried out by the person himself. There is no intervention by a health professional. “The antigenic self-tests represent additional screening tools to the tests already used in France, argue la HAS. (…) Their use makes it possible to promote an approach “going towards”, in particular in order to reach populations far from the healthcare system. And a nasal swab is a more acceptable option than a nasopharyngeal swab when the tests need to be repeated regularly. “
Nowadays, saliva self-tests are not authorized in France by the HAS. Only self-tests with a sample from the nose are marketed.
Self-tests, even under the supervision of health professionals, are not recognized for traveling outside France.
The negative self-test of less than 72 hours was made valid as proof of the health pass on August 9, 2021. But as of October 15, 2021, this will no longer be the case: self-tests carried out under the supervision of a health professional will no longer be recognized as proof for the health pass. Self-tests carried out without supervision remain accessible for individual monitoring but will still not give access to the health pass.
A self-test is valid 72 hours.
Supervised self-tests are supported such as antigen testing and RT-PCR testing. The supervised self-tests can be carried out in certain pharmacies, or in barnums organized in particular on the initiative of local authorities or within health, social and medico-social establishments for personnel subject to compulsory vaccination.
What is the principle of the Covid-19 self-tests?
As part of the screening for Covid-19, the self-tests validated by the Haute Autorité de Santé on March 16, 2021 are nasal antigenic self-tests. Unlike the antigen test available since October 2020 in France, the self-test is carried out on a deep nasal swab and not a nasopharyngeal swab (which is even deeper). The result of the self-test is also fast.
→ Antigenic self-tests look for the presence of coronavirus DNA in the body to show if the person is infected when they are tested. This is the same principle as the nasopharyngeal antigen tests.
How reliable is the result?
The reliability of the antigenic self-tests has been “extrapolated” based on the performance results observed for the rapid TDR and TROD tests in the context of screening for Covid-19. According to the first data analyzed by the HAS, these tests have clinical sensitivities of the order of 80 to 95% in symptomatic patients and of 50 to 60% in asymptomatic people. HAS emphasizes that monitoring the performance of self-tests under actual conditions of use is essential. In children “a meta-analysis carried out by the HAS shows encouraging results” indicates authority on April 26.
Who are they recommended for?
Indications antigenic self-tests have changed in April 2021. The HAS has withdrawn the age limit initially set at 15 years. Self-tests can thus be carried out on asymptomatic people, adults and children, in the following two situations:
- Medical indication, as part of a large-scale targeted iterative screening as an alternative to rapid diagnostic test (RDT) and rapid diagnostic orientation test (TROD) on nasopharyngeal or nasal sample.
- Indication within the framework of a use restricted to the private sphere (for example, before a meeting with relatives…).
“The risk of false-negative exists and is a little higher than with other tests”
When to do a self-test?
In the private sphere, the test should ideally be done the same day or failing that the day before a visit to a loved one (or an outing to the cinema, to a restaurant, etc.). “By repeating the sample, for example once or twice a week, the chances of detecting the virus at the onset of the disease are increased, indicates the Ministry of Health. In the event of symptoms or contact with a person who tests positive for Covid, an RT-PCR or antigen test should be done in the laboratory or at a healthcare professional. ” These self-tests detect variants currently dominant of the three main lineages: the UK variant, the SA variant and the BR-P1 variant.
A self-test for Covid-19 must be performed by a nasal swab, with the antigen test performed immediately after.
- Wash your hands with soap and water or with hydroalcoholic gel.
- Take all items out of the test box and place them on a well-cleaned, flat surface. Identify each item in the test kit.
- The swab must be introduced vertically into one nostril on 2 to 3 cm (or even 4 cm according to the tests) without forcing, then gently rock it horizontally and insert it a little until you meet a slight resistance. Some swabs have a collar to help assess the depth of their introduction.
- Then perform a rotational movement inside the nostril. For some tests, a second nostril is required. If this is the case, do the same in the other nostril with the same swab. Then follow the instructions for use for extracting and reading the test result on the cassette.
→ The test and the interpretation of the test must be carried out according to the conditions defined by the manufacturer in its instructions for use.
The self-tests deliver their results in 15 to 30 minutes.
The result is read in a few minutes:
- (+) The result is POSITIVE if two colored bands appear in areas (C) and (T).
- (-) The test result is NEGATIVE if a colored band appears only in the control area (C).
- (X) If the control line (C) does not appear, the result is INVALID. You have to redo a self-test. If in doubt about the result, consult your pharmacist.
- Dispose of the kit items in a plastic bag to avoid contamination. Close the bag and place it in a second plastic bag. Throw everything in its usual trash. Wash hands after handling.
Positive result: what to do?
The result is positive if two colored bands appear in areas (C) and (T). In the event of a positive test, one must isolate himself immediately for 10 days and inform the contact cases to be tested as well. The positive result of a self-test must be confirmed by RT-PCR test nasopharyngeal to be performed in the laboratory. The risk of “false positive” is estimated at less than 1%.
The test result is negative if a colored band appears only in the control area (C). If a self-test is negative, it do not give up barrier gestures and social distancing, especially when visiting relatives “because the risk of false-negative exists and which is a little higher than with the other tests” Olivier Véran warned during the April 22 conference. If there is any doubt or if symptoms suggestive of Covid-19 occur, I do a PCR or nasopharyngeal antigen test.
Covid self-tests have been available over the counter in pharmacies since April 12, 2021. They are available without a prescription.
Covid self-tests have been available over the counter to the general public in French pharmacies since April 12. They are covered only for home helpers and family carers. “Workers in contact with unvaccinated fragile people can use these self-tests paid for by Health Insurance, at the rate of 10 self-tests per month” said Olivier Véran. In pharmacies:
► the person can therefore buy a self-test and do it at home
► or ask do it on site under the supervision of the pharmacist. In this case, it is advisable to bring an identity document and to fill in this form before performing the self-test.
In accordance with the decree of April 11, the sale of self-tests for Covid-19 is prohibited on the Internet by the Ministry of Health in France.
According to the decree published in the Official Journal on April 11, the selling prices of self-tests cannot exceed, per test and all taxes included, 5,20 euros.
Self-tests used in the private sphere are not covered by Health Insurance except for home service employees working with elderly or disabled people (SAAD, SPASAD, SSIAD, SAVS, SAMSAH, SESSAD); employees of private employers working with elderly or disabled people for essential acts of life; the family carers mentioned inarticle L. 441-1 of the code of social action and families accompanying elderly or disabled people.
RT-PCR, antigenic and salivary tests. Ministry of Health. February 4, 2021.
Covid-19: the HAS lifts the age limit for the use of antigenic tests on nasal swab. Press release posted on April 26, 2021.
Opinion of the COVID-19 Scientific Council April 19, 2021 Self-tests: a public health opportunity.
Self-tests. Ministry of Health. March 30, 2021.
Covid-19: what place for nasal antigen tests in the screening strategy? HAS press release March 16, 2021.
Opinion n ° 2021.0015 / AC / SEAP of March 15, 2021 of the College of the High Authority for Health relating to the rapid antigenic detection of the SARS-CoV-2 virus on nasal swab (TDR, TROD and self-test)