NDLI: Evaluation of the Advanta Dx SARS-CoV-2 RT-PCR Assay, a High-Throughput Extraction-Free Diagnostic Test for the Detection of SARS-CoV-2 in Saliva: A Diagnostic Accuracy Study

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Evaluation of the Advanta Dx SARS-CoV-2 RT-PCR Assay, a High-Throughput Extraction-Free Diagnostic Test for the Detection of SARS-CoV-2 in Saliva: A Diagnostic Accuracy Study

Content Provider	MDPI
Author	Balaska, Sofia Pilalas, Dimitrios Takardaki, Anna Koutra, Paraskevoula Parasidou, Eleftheria Gkeka, Ioanna Tychala, Areti Meletis, Georgios Fyntanidou, Barbara Metallidis, Simeon Protonotariou, Efthymia Skoura, Lemonia
Copyright Year	2021
Description	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.
Starting Page	1766
e-ISSN	20754418
DOI	10.3390/diagnostics11101766
Journal	Diagnostics
Issue Number	10
Volume Number	11
Language	English
Publisher	MDPI
Publisher Date	2021-09-26
Access Restriction	Open
Subject Keyword	Diagnostics Microbiology Covid-19 Sars-cov-2 Saliva Pcr
Content Type	Text
Resource Type	Article

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