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The Haute Autorité de Santé this Saturday 28 November in favor of the saliva test for the screening of the coronavirus for symptomatic people. Researchers contest reservations holding back wider spread.
Favorable but … The High Authority for Health (HAS) released on Saturday 28 November a much awaited opinion on the interest of the EasyCoV Montpellier saliva test to detect Covid-19, the result of a research conducted by the CNRS through the start -up SkillCell, with the University Hospital of Montpellier, which has opened its screening center for clinical trials. Very promising according to its authors, impatient and circumspect (1) in the face of the delays of the HAS in recent months.
The High Authority is less enthusiastic. Recommend, with many brakes. It thus validates the use of the EasyCoV saliva test and actually authorizes it reimbursement by social security, but only in symptomatic subjects, “for which nasopharyngeal sampling is impossible or difficult to perform”. The sample must be taken by a biologist, EasyCoV will not be found in the pharmacy, such as antigenic tests with extended parallel recommendations, despite their imperfections. The stakes are high because the market is colossal.
Not for asymptomatic people
If the test is positive, the HAS also recommends “to carry out a control by RT-PCR on a saliva sample”. If the non-invasive, intelligent, color-coded and innovative device seduced the HAS, with its miniaturized automaton that processes the sample and analysis in about thirty minutes “against at least several hours for RT-PCR”, its flaws now prevent us from going further.
“The sensitivity of the EasyCoV test is satisfactory for symptomatic patients (84%). On the other hand, the specificity is not: at 92%, it is below the minimum performance required by the HAS”, recommends a sensitivity of 80% and a specificity of 99%.
Otherwise, “The lack of solid clinical data on performance in asymptomatic individuals does not allow to recommend it at this stage in this situation”, estimates the HAS.
It is intellectual dishonesty
“The test is more efficient than the HAS claims to be intellectual dishonesty”, fulminates Jacques Reynes, head of the infectious disease unit at the University Hospital of Montpellier, where the test was evaluated and balanced with two other techniques, nasopharyngeal PCR and salivary PCR. With Franck Molina, CNRS lead researcher of the Montpellier laboratory Sys2Diag, who developed the technological process, he proposes other more favorable results, provided, they assure, to HAS.
“ Out of 488 tested subjects, of which 443 who went to the CHU screening drive – the others were hospitalized –, we get a sensitivity of 86 % and a specificity of 99.5 %. In symptomatic people, 263 subjects, the figures are 84 respectively % and 99.03 %. Among the asymptomatic subjects, 183 subjects, 93 % sensitivity, 100 % specificity “.
Against the attack of the CHU and the CNRS in Montpellier next week
The debate, technique (1), is the subject of controversy, on the transmission of data, on their reliability. The University Hospital of Montpellier and the CNRS plan to fight back next week. On Saturday, the HAS had the final say through its president, Dominique Le Guludec, and the head of the assessment service, Dr Cédric Carbonneil: “EasyCoV will have to confirm”. “As soon as we have more reliable data, we change our mind”, emphasizes Professor Le Guludec.
Franck Molina, “stunned by the scientific and intellectual bad faith of the HAS”, played an appeasement yesterday: “We have the green light, it’s still great news, we’ll see what happens next. And they ended up saying ‘yes’ to saliva, it’s a first step”.
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