Evaluation of a saliva molecular point of care for the detection of SARS-CoV-2 in ambulatory care

© 2021. The Author(s)..

Rapid identification of SARS-CoV-2-infected individuals is a cornerstone for the control of virus spread. The sensitivity of SARS-CoV-2 RNA detection by RT-PCR is similar in saliva and nasopharyngeal swabs. Rapid molecular point-of-care tests in saliva could facilitate, broaden and speed up the diagnosis. We conducted a prospective study in two community COVID-19 screening centers to evaluate the performances of a CE-marked RT-LAMP assay (EasyCoV) designed for the detection of SARS-CoV2 RNA from fresh saliva samples, compared to nasopharyngeal RT-PCR, to saliva RT-PCR and to nasopharyngeal antigen testing. Overall, 117 of the 1718 participants (7%) tested positive with nasopharyngeal RT-PCR. Compared to nasopharyngeal RT-PCR, the sensitivity and specificity of the RT-LAMP assay in saliva were 34% and 97%, respectively. The Ct values of nasopharyngeal RT-PCR were significantly lower in the 40 true positive subjects with saliva RT-LAMP (Ct 25.9) than in the 48 false negative subjects with saliva RT-LAMP (Ct 28.4) (p = 0.028). Considering six alternate criteria for reference tests, including saliva RT-PCR and nasopharyngeal antigen, the sensitivity of saliva RT-LAMP ranged between 27 and 44%. The detection of SARS-CoV-2 in crude saliva samples with an RT-LAMP assay had a lower sensitivity than nasopharyngeal RT-PCR, saliva RT-PCR and nasopharyngeal antigen testing.Registration number: NCT04578509.

Medienart:

E-Artikel

Erscheinungsjahr:

2021

Erschienen:

2021

Enthalten in:

Zur Gesamtaufnahme - volume:11

Enthalten in:

Scientific reports - 11(2021), 1 vom: 26. Okt., Seite 21126

Sprache:

Englisch

Beteiligte Personen:

LeGoff, Jérôme [VerfasserIn]
Kernéis, Solen [VerfasserIn]
Elie, Caroline [VerfasserIn]
Mercier-Delarue, Séverine [VerfasserIn]
Gastli, Nabil [VerfasserIn]
Choupeaux, Laure [VerfasserIn]
Fourgeaud, Jacques [VerfasserIn]
Alby, Marie-Laure [VerfasserIn]
Quentin, Pierre [VerfasserIn]
Pavie, Juliette [VerfasserIn]
Brazille, Patricia [VerfasserIn]
Néré, Marie Laure [VerfasserIn]
Minier, Marine [VerfasserIn]
Gabassi, Audrey [VerfasserIn]
Leroy, Chrystel [VerfasserIn]
Parfait, Béatrice [VerfasserIn]
Tréluyer, Jean-Marc [VerfasserIn]
Delaugerre, Constance [VerfasserIn]

Links:

Volltext

Themen:

Evaluation Study
Journal Article
RNA, Viral
Research Support, Non-U.S. Gov't

Anmerkungen:

Date Completed 15.11.2021

Date Revised 15.11.2021

published: Electronic

ClinicalTrials.gov: NCT04578509

Citation Status MEDLINE

doi:

10.1038/s41598-021-00560-8

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM332412644