Nasopharyngeal swab specimen (NPS) molecular testing is considered the gold standard for SARS-CoV-2 detection. However, saliva is an attractive, noninvasive specimen alternative. The aim of the study was to evaluate the diagnostic accuracy of Advanta Dx SARS-CoV-2 RT-PCR saliva-based assay against paired NPS tested with either NeumoDx TM SARS-CoV-2 assay or Abbott Real Time SARS-CoV-2 assay as the reference method. We prospectively evaluated the method in two settings: a diagnostic outpatient and a healthcare worker screening convenience sample, collected in November–December 2020. SARS-CoV-2 was detected in 27.7% (61/220) of diagnostic samples and in 5% (10/200) of screening samples. Overall, saliva test in diagnostic samples had a sensitivity of 88.5% (77.8–95.3%) and specificity of 98.1% (94.6–99.6%); in screening samples, the sensitivity was 90% (55.5–99.7%) and specificity 100% (98.1–100%). Our data suggests that the Fluidigm Advanta Dx RT-PCR saliva-based assay may be a reliable diagnostic tool for COVID-19 diagnosis in symptomatic individuals and screening asymptomatic healthcare workers.
【저자키워드】 COVID-19, SARS-CoV-2, Saliva, PCR, 【초록키워드】 diagnostic, RT-PCR, healthcare worker, SARS-CoV-2 detection, sensitivity, specificity, Asymptomatic, Accuracy, healthcare, COVID-19 diagnosis, Swab, SARS-CoV-2 RT-PCR, molecular, noninvasive, saliva test, Abbott, gold standard, specimen, reference method, NPs, time, tested, collected, evaluate, evaluated, symptomatic individual, 【제목키워드】 Test, detection, SARS-CoV-2 RT-PCR,