Orange with Media Services, published on Thursday, July 29, 2021 at 5:40 p.m.
These so-called “integrated” tests give a result on the presence or absence of the virus in about forty minutes, from a sample of saliva.
The French High Authority for Health (HAS) considers that rapid saliva screening tests for Covid-19 “present performance that is too heterogeneous”, and therefore “suspends” its recommendation that these devices be covered by Social Security.
Of “new data available reveal a great variability of the results obtained, calling into question their effectiveness. In addition, reliable alternatives with the same levels of acceptability or speed now exist “, explains HAS in a press release.
The main rapid saliva test, from the company EasyCov, has been reimbursable by Social Security since the beginning of January. The HAS had recommended on November 28 its use and reimbursement, but only “in symptomatic people for whom nasopharyngeal sampling (by swab, Editor’s note) is impossible or difficult to achieve”.
This recommendation had been taken “taking into account the potential interest of the product and the health context”, but “the diagnostic performance data available came from a single study carried out by the manufacturer and presented methodological biases linked to the practical conditions of use. its realization “, explains the health authority.
Recommended antigenic tests
The new performance data analyzed relates to four available tests (EasyCov distributed by Skillcell, Genelyzer FII distributed by Canon Medical, ID NOW distributed by Abbott Diagnostics and OptiGene distributed by the company of the same name).
They show a good level of specificity, that is to say their ability not to conclude wrongly that an uninfected person is positive “with results from 97% to 99%”.
Very heterogeneous results
On the other hand, the sensitivity data (their ability not to miss infected people) “are problematic since these tests present very heterogeneous results varying from 30% to 90%, without any real explanation”, underlines the HAS.
The only saliva tests that can be reimbursed will therefore now be those that require a laboratory analysis by PCR.
As for situations requiring a rapid result, the HAS recommends the use of antigenic tests and reminds that they can be carried out on a nasopharyngeal sample but also on a nasal sample, less deep, as is the case for self-tests.