Abstract
The reliable identification of individuals with SARS-CoV-2 infection is the cornerstone for containing viral spread. Rapid molecular point-of-care testing (POCT) of saliva might reduce analysis time, thus increasing the efficacy of contact tracing. In this study, a new POCT RT-PCR assay for the detection of SARS-CoV-2 RNA in saliva was evaluated and compared with an already validated CE-IVD method. An evaluation was made of 160 left-over salivary samples (27 frozen, kept at-80°C and 133 fresh), collected using Salivette (Sarstedt, Germany). Samples were analyzed by TaqPath COVID-19 CE-IVD RT-PCR kit, QuantStudio5 Real-Time (Applied Biosystems, USA) (TaqPath) and bKIT Virus Finder COVID-19 Saliva (Hyris Global Diagnostics, Italy). Performances of three- and fivefold pooling strategies were also evaluated. Blood assay interference in saliva was also tested with Hyris. On using TaqPath, SARS-CoV-2 positivity was detected in 35 samples. Another 10 positive samples were artificially-generated by blind mixing of positive with negative samples. Hyris positive and negative percentages of agreement were 97.6 (95% CI: 87.2-99.9%) and 100 (95% CI: 97.0-100%), respectively. Seventeen positive pools, evaluated for threefold strategy, were all correctly determined by both systems. For the 5-pool strategy, 94.7% (18/19) of samples resulted positive with the Hyris system, and 100% with TaqPath. The presence of 1% of blood (v/v) in saliva did not interfere with the accuracy of Hyris assay. The sensitivity and specificity of the bKIT Virus Finder COVID-19 Saliva were optimal with respect toTaqPath. In view of the safe and straightforward pre-analytical procedure involved, and the small size of the Hyris bCube, the Hyris system can be used for POCT.
Highlights
The fourth wave of Coronavirus Disease 2019 (COVID-19) has afflicted countries worldwide since late summer 2021
The real-time reverse transcription polymerase chain reaction test for SARS-CoV-2 diagnosis has a very high analytical sensitivity [3], and has been endorsed for confirming a diagnosis of COVID-19, and in situations calling for reliable testing, such as screening of healthcare workers and following the pre-hospitalization protocol for surgery candidates [4]
We evaluated the clinical performances of a new point-of-care testing (POCT) device, the Hyris system, consisting of the bKIT Virus Finder COVID-19, the bCUBE and the bAPP, in detecting SARS-CoV-2 in salivary samples
Summary
The fourth wave of Coronavirus Disease 2019 (COVID-19) has afflicted countries worldwide since late summer 2021. While the number of test requests has increased, pressure on clinical laboratories has become critical, and alternative testing strategies are urgently needed in order to ensure the timely detection of positive individuals. To assure accuracy of results, analytical systems able to detect SARS-CoV-2 with high clinical sensitivity and specificity are mandatory, especially for the screening of asymptomatic subjects [2]. The real-time reverse transcription polymerase chain reaction (rRT-PCR) test for SARS-CoV-2 diagnosis has a very high analytical sensitivity [3], and has been endorsed for confirming a diagnosis of COVID-19, and in situations calling for reliable testing, such as screening of healthcare workers and following the pre-hospitalization protocol for surgery candidates [4]. The rRT-PCR evaluation of large numbers of samples might call for elevated automation, several instrumentations and
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