SARS-CoV-2 detection using reverse transcription strand invasion based amplification and a portable compact size instrument

Maiken W Rosenstierne, Shreya Joshi, E Thomas Danielsen, Helen Webb, Dac Mui Luong, Julie Bjerring, Julie Hindkær, Lærke Jørgensen, Julie Blauenfeldt, Ask Bojesen, Flemming Holck, Johnny Weber Lau, Lars Bangsgaard, Jakob Broberg Lind, Mette Bjergaard Dragheim, Mikkel Rohde Jacobsen, Robert Elkjær, Steven Clauwaert, Kristina Christensen, Charlotta PolacekAnders Fomsgaard, Tuomas Ojalehto, Antti Tullila, Mirko Brummer, Claus Juel Jensen, Frederikke Holm Jensen, Uffe Vest Schneider, Jan Gorm Lisby, Rikke Lind Jørgensen, Thomas Warthoe, Ebbe Finding, Peter Warthoe

Abstract

Rapid nucleic-acid based tests that can be performed by non-professionals outside laboratory settings could help the containment of the pandemic SARS-CoV-2 virus and may potentially prevent further widespread lockdowns. Here, we present a novel compact portable detection instrument (the Egoo Health System) for extraction-free detection of SARS-CoV-2 using isothermal reverse transcription strand invasion based amplification (RT-SIBA). The SARS-CoV-2 RT-SIBA assay can be performed directly on crude oropharyngeal swabs without nucleic acid extraction with a reaction time of 30 min. The Egoo Health system uses a capsule system, which is automatically sealed tight in the Egoo instrument after applying the sample, resulting in a closed system optimal for molecular isothermal amplification. The performance of the Egoo Health System is comparable to the PCR instrument with an analytical sensitivity of 25 viral RNA copies per SARS-CoV-2 RT-SIBA reaction and a clinical sensitivity and specificity between 87.0-98.4% and 96.6-98.2% respectively.

OriginalsprogEngelsk
Artikelnummer22214
TidsskriftScientific Reports
Vol/bind11
Udgave nummer1
Sider (fra-til)1-13
Antal sider13
ISSN2045-2322
DOI
StatusUdgivet - 15 nov. 2021

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