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 Polacek; Anders 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

doi:10.1038/s41598-021-01744-y

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.

Original language	English
Article number	22214
Journal	Scientific Reports
Volume	11
Issue number	1
Pages (from-to)	1-13
Number of pages	13
ISSN	2045-2322
DOIs	https://doi.org/10.1038/s41598-021-01744-y
Publication status	Published - 15 Nov 2021

Keywords

COVID-19/diagnosis
Cell Phone
Equipment Design
Humans
Mobile Applications
Molecular Diagnostic Techniques/instrumentation
Oropharynx/virology
Pandemics/prevention & control
Point-of-Care Testing
Polymorphism, Single Nucleotide
RNA, Viral/genetics
Retrospective Studies
Reverse Transcriptase Polymerase Chain Reaction/instrumentation
SARS-CoV-2/genetics
Sensitivity and Specificity

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10.1038/s41598-021-01744-y

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Rosenstierne, M. W., Joshi, S., Danielsen, E. T., Webb, H., Luong, D. M., Bjerring, J., Hindkær, J., Jørgensen, L., Blauenfeldt, J., Bojesen, A., Holck, F., Lau, J. W., Bangsgaard, L., Lind, J. B., Dragheim, M. B., Jacobsen, M. R., Elkjær, R., Clauwaert, S., Christensen, K., ... Warthoe, P. (2021). SARS-CoV-2 detection using reverse transcription strand invasion based amplification and a portable compact size instrument. Scientific Reports, 11(1), 1-13. [22214]. https://doi.org/10.1038/s41598-021-01744-y

Rosenstierne, MW, Joshi, S, Danielsen, ET, Webb, H, Luong, DM, Bjerring, J, Hindkær, J, Jørgensen, L, Blauenfeldt, J, Bojesen, A, Holck, F, Lau, JW, Bangsgaard, L, Lind, JB, Dragheim, MB, Jacobsen, MR, Elkjær, R, Clauwaert, S, Christensen, K, Polacek, C, Fomsgaard, A, Ojalehto, T, Tullila, A, Brummer, M, Jensen, CJ , Jensen, FH, Schneider, UV, Lisby, JG , Jørgensen, RL, Warthoe, T, Finding, E & Warthoe, P 2021, 'SARS-CoV-2 detection using reverse transcription strand invasion based amplification and a portable compact size instrument', Scientific Reports, vol. 11, no. 1, 22214, pp. 1-13. https://doi.org/10.1038/s41598-021-01744-y

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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.",

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AU - Rosenstierne, Maiken W

AU - Joshi, Shreya

AU - Danielsen, E Thomas

AU - Webb, Helen

AU - Luong, Dac Mui

AU - Bjerring, Julie

AU - Hindkær, Julie

AU - Jørgensen, Lærke

AU - Blauenfeldt, Julie

AU - Bojesen, Ask

AU - Holck, Flemming

AU - Lau, Johnny Weber

AU - Bangsgaard, Lars

AU - Lind, Jakob Broberg

AU - Dragheim, Mette Bjergaard

AU - Jacobsen, Mikkel Rohde

AU - Elkjær, Robert

AU - Clauwaert, Steven

AU - Christensen, Kristina

AU - Polacek, Charlotta

AU - Fomsgaard, Anders

AU - Ojalehto, Tuomas

AU - Tullila, Antti

AU - Brummer, Mirko

AU - Jensen, Claus Juel

AU - Jensen, Frederikke Holm

AU - Schneider, Uffe Vest

AU - Lisby, Jan Gorm

AU - Jørgensen, Rikke Lind

AU - Warthoe, Thomas

AU - Finding, Ebbe

AU - Warthoe, Peter

PY - 2021/11/15

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N2 - 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.

AB - 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.

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KW - Pandemics/prevention & control

KW - Point-of-Care Testing

KW - Polymorphism, Single Nucleotide

KW - RNA, Viral/genetics

KW - Retrospective Studies

KW - Reverse Transcriptase Polymerase Chain Reaction/instrumentation

KW - SARS-CoV-2/genetics

KW - Sensitivity and Specificity

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DO - 10.1038/s41598-021-01744-y

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JO - Scientific Reports

JF - Scientific Reports

SN - 2045-2322

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ER -

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

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Keywords

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