In early December 2019, an outbreak of coronavirus disease 2019 (COVID-19), caused by a novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), occurred in Wuhan City, China. Less than one month later, nearly 10 thousand cases were confirmed in China and 82 in 18 other countries, preannouncing the high infectivity of this new coronavirus. Subsequently, several studies confirmed that the average of secondary cases that can be infected by a SARS-CoV-2 positive subject (known as R0 index) is much higher than that of coronaviruses causing SARS and Middle East Respiratory Syndrome (MERS). SARS-CoV-2 has more potential to cause a pandemic, which came true within a short time span [1
]. Since its discovery, the number of confirmed cases of COVID-19 worldwide exceeds 100 million while the number of global deaths exceeds 2 million. COVID-19 is mainly transmitted by respiratory droplets and aerosol. The incubation period (between contamination and the appearance of the first symptoms) is usually 3–5 days [3
]. Early diagnosis of SARS-CoV-2 infection is paramount for disease treatment and infection control. Viral RNA detection by reverse transcription-quantitative real-time polymerase chain reaction (qRT-PCR) on specimens collected by healthcare workers using nasopharyngeal swabs and transported in an appropriate transport medium is the gold standard for diagnosis of SARS-CoV-2 infection [4
]. Diagnostic accuracy mainly relies on sample collection appropriateness, specimen stability, and qRT-PCR quality performed on three different viral genes. Copan FLOQSwabs have been already described as capable of preserving RNA of respiratory viruses to be used in molecular analyses without requiring a transport medium [5
]. Smieja and collaborators demonstrated that nasal mid-turbinated (MT) FLOQSwabs were able to harvest significantly more respiratory epithelial cells than conventional rayon swabs, thus confirming their appropriateness for the diagnosis of infections due to respiratory viruses and suggesting their suitability for self-collection [1
]. Moore and colleagues showed that “dry swabs”—not immerged in transport medium for transport and storage—can be used for detecting respiratory viruses with molecular methods, even two weeks after the collection [10
]. Finally, a recent publication reported that dry swabs, eluted directly into a simple buffered solution, could support molecular detection of SARS-CoV-2 without compromising assay sensitivity [11
]. The main objective of our study was to determine feasibility, acceptability, and diagnostic performances of the developed Testami home self-collection for the SARS-CoV2 RNA testing program, which is based on qRT-PCR detection of SARS-CoV2 RNA in home self-collected specimens by using nasal MT FLOQSwabs transported in a dry tube. To this goal, we firstly evaluated the accuracy of sampling in unsupervised self-collected (SC) and healthcare professional (HCP) collected swabs. Thereafter, the stability of RNA in “dry conditions” was assessed. Finally, diagnostic parameters of the Testami home self-collection program were compared to the standard diagnostic routine for SARS-CoV-2 infection, based on a collection of nasopharyngeal samples by healthcare workers.