The High Authority for Health (HAS) believes this Wednesday that rapid saliva screening tests for Covid-19 "present too heterogeneous performance".
It therefore “suspends” its recommendation that these devices be covered by Social Security.
“New data available (…) reveal a great variability in 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.
# Press release |
# COVID19: the performances of the RT-LAMP saliva tests are too heterogeneous
📌 The HAS suspends its recommendation to support RT-LAMP saliva tests with an “integrated” system 👉 https://t.co/P6GNgc814y
The opinion 👉 https://t.co/OzZRGNMmFz pic.twitter.com/pT8DzMEvt7
- Haute Autorité de santé (@HAS_sante) July 28, 2021
These so-called “integrated” tests give a result on the presence or absence of the virus in about forty minutes, from a saliva sample.
"Methodological biases"
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 - rapid and non-invasive technology - 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 its realization ”, explains the health authority.
Risk of missing infected people
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, their ability not to mistakenly conclude that an uninfected person is positive - "with results from 97% to 99%".
On the other hand, the sensitivity data - their ability not to miss infected people - "are problematic since these tests present very heterogeneous results ranging 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.
