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