Coronavirus: saliva tests now authorized

In an opinion made public on Saturday 28 November, the High Authority for Health (HAS) said it was in favor of the use of the EasyCov diagnostic test which allows the presence of SARS-CoV-2 to be detected in a few minutes through the collection of saliva . Enough to arouse immense hopes in the fight against the coronavirus epidemic, to be mitigated however.

In his opinion, the HAS, whose role in France is to assess the medical interest of drugs but also of medical devices, is the first to confirm only a first recommendation issued last September.

Also, saliva tests, if now authorized, are only allowed under certain conditions and for a specific type of test. These tests can therefore only be used on people who show symptoms of the coronavirus and only if it is the so-called “integrated” EasyCov test, an innovation that we owe to the CNRS and the University Hospital of Montpellier.

#Communication | HAS decides RT-LAMP saliva tests (“non-integrated” and “integrated” #EasyCov) and updates the indications for antigen tests in contact persons

https://t.co/RC4xcJt5wo

We unroll ⤵ pic.twitter.com/jkoUGUIz2G

– Haute Autorité de santé (@HAS_sante) November 28, 2020

“The sensitivity of the EasyCov test is satisfactory for symptomatic patients (84%). On the other hand, the specificity is not: with 92% it is below the minimum performance required by the HAS ”, writes the institution in his opinion.

In medicine, the sensitivity of a test allows you to know the proportion of patients diagnosed by this test. Specificity corresponds to the percentage of non-patients diagnosed by this test. Clearly, in the absence of symptoms, the risk of false positives, with their risk of inappropriate invasive tests, or false negatives, with delayed treatment, remains too high.

Therefore, HAS advocates the use and reimbursement of the EasyCov saliva test only, it states, “in symptomatic patients for whom nasopharyngeal sampling is impossible or difficult to perform.”

No availability date communicated

Specifically, a person with fever, severe headache and breathing difficulties could therefore soon resort to these tests that will be carried out by doctors or pharmacists, even if no actual date of marketing has yet been announced.

As a reminder, these tests consist of taking saliva with a pipette. Once the saliva is collected, it is placed in a small machine the size of a shoe box.

After a warm-up process of approximately forty minutes, the color changes and indicates a positive or negative result. A considerable saving of time, therefore, and above all a much less invasive method than the now known nasal swab.

But a device that is only useful in specific circumstances without being foolproof. Ultimately, the saliva test should therefore be seen more as a first precaution, certainly important, but in addition to PCR tests and antigen tests.

In his view, the High Authority for Health has also rightly recommended expanding the use of antigen tests. If they also mainly concern people with symptoms, they can still be practiced in the future on symptom-free contact cases. This is to be more responsive to the virus.