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.
Highlights
Rapid identification of SARS-CoV-2-infected individuals is a cornerstone for the control of virus spread
Recent meta-analyses assessed the performances of saliva RT-PCR tests for the diagnosis of COVID-1915–18, and we recently confirmed in a large prospective study the excellent sensitivity of saliva RT-PCR, as compared to nasopharyngeal RT-PCR, for the detection of SARS-CoV-2 in community screening centers[19]
We conducted a prospective study in two community COVID-19 screening centers to evaluate the performances of a CE-marked RT-loopmediated isothermal amplification (LAMP) assay designed for the detection of SARS-CoV-2 RNA from fresh saliva samples compared to nasopharyngeal RT-PCR, saliva RT-PCR and nasopharyngeal antigen point-of-care (Ag) tests
Summary
Rapid identification of SARS-CoV-2-infected individuals is a cornerstone for the control of virus spread. 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. 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. Recent meta-analyses assessed the performances of saliva RT-PCR tests for the diagnosis of COVID-1915–18, and we recently confirmed in a large prospective study the excellent sensitivity of saliva RT-PCR, as compared to nasopharyngeal RT-PCR, for the detection of SARS-CoV-2 in community screening centers[19]. No studies have estimated the performances of RT-LAMP on saliva samples as pointof-care systems directly in screening centers
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