Hyris bCUBE SARS-CoV-2 rapid molecular saliva testing: a POCT innovation on its way

Objectives: 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. Methods: 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. Results: 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. Conclusions: The sensitivity and specificity of the bKIT Virus Finder COVID-19 Saliva were optimal with respect to TaqPath. 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.

Object Details

• Location: Deutsche Nationalbibliothek Frankfurt am Main
• Extent: Online-Ressource
• Language: Englisch

References and Relationships

• Bibliographic citation: Hyris bCUBE SARS-CoV-2 rapid molecular saliva testing: a POCT innovation on its way ; volume:60 ; number:5 ; year:2022 ; pages:766-770 ; extent:05 ; Clinical chemistry and laboratory medicine ; 60, Heft 5 (2022), 766-770 (gesamt 05)

Contributors, Places and Time

• Creator: Padoan, Andrea ; Cosma, Chiara ; Aita, Ada ; Navaglia, Filippo ; Basso, Daniela ; Giannella, Gianfranco ; Plebani, Mario

Further information

• DOI: 10.1515/cclm-2022-0008
• URN: urn:nbn:de:101:1-2022052411303257820014
• Rights: Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
• Last update: 15.08.2025, 7:26 AM CEST