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.
【저자키워드】 SARS-CoV-2, Infectious diseases, Virology, Molecular medicine, 【초록키워드】 COVID-19, Saliva, SARS-CoV2, Prospective Study, Diagnosis, RT-PCR, Antigen, RNA, RT-LAMP, sensitivity, Sensitivity and specificity, nasopharyngeal swabs, nasopharyngeal, LAMP, Rapid, Community, molecular, point-of-care test, False negative, SARS-CoV-2 RNA detection, Ct values, criteria, registration number, reference tests, subject, infected individuals, virus spread, cornerstone, participant, SARS-CoV-2-infected individuals, positive, significantly lower, tested, evaluate, conducted, facilitate, ranged, SARS-CoV-2-infected individual, 【제목키워드】 point of care, molecular, Care,