1. Evaluation of a saliva molecular point of care for the detection of SARS-CoV-2 in ambulatory care.
- Author
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LeGoff, Jérôme, Kernéis, Solen, Elie, Caroline, Mercier-Delarue, Séverine, Gastli, Nabil, Choupeaux, Laure, Fourgeaud, Jacques, Alby, Marie-Laure, Quentin, Pierre, Pavie, Juliette, Brazille, Patricia, Néré, Marie Laure, Minier, Marine, Gabassi, Audrey, Leroy, Chrystel, Parfait, Béatrice, Tréluyer, Jean-Marc, and Delaugerre, Constance
- Subjects
POINT-of-care testing ,SARS-CoV-2 ,SALIVA ,OUTPATIENT medical care ,REVERSE transcriptase polymerase chain reaction ,SALIVA analysis - Abstract
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. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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