France: Covid-19 coronavirus: French High Health Authority approves salivary tests to complement nasopharyngeal tests in symptomatic people

Jeanne Fabre

On 18 September 2020, the French High Health Authority (HAS) issued a press release announcing that it had approved the use of virological tests (RT-PCR) on saliva samples. The advantage of these tests is that they make sampling easier, reduce the risk of contamination for healthcare personnel and are less unpleasant for patients (notably children, elderly people and people with psychiatric disorders). The saliva collection is carried out by simply spitting or by pipetting the saliva. It can be carried out by self-collection or supervised by a healthcare professional.

Available data shows that tests on saliva samples are somewhat less sensitive than on nasopharyngeal swabs for detecting the virus in symptomatic individuals. However, given their greater acceptability by patients, the HAS is in favour of their use and reimbursement as explained in Opinion no 2020.047/AC/SEAP, with preference being given to symptomatic people for whom nasopharyngeal sampling is difficult or impossible. The HAS does not recommend using salivary tests for asymptomatic people, as the results can be very unreliable.

The HAS points out that there is a risk that carrying out a greater number of tests, given the greater acceptability of the saliva sample tests, may worsen the bottleneck in the analytical phase (RT-PCR stage). If this is the case, the increase in the time taken to report the results would have a negative organisational impact despite the increase in the number of tests carried out.

The HAS’s position may be reviewed or clarified, in particular in the light of the following considerations:

  • The final results of the COVISAL or other data from clinical studies with the same level of evidence as COVISAL (including the SALMICOV study currently underway that is being promoted by the Army Health Service).
  • The diagnostic performance of antigenic tests.

HAS’s opinion on the detection of the viral genome by RT-PCR on saliva samples will soon be supplemented by other opinions on the use of antigenic tests for symptomatic patients, on oropharyngeal samples and on the overall diagnosis and screening strategy.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, October 2020 Issue (Thomson Reuters).

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