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

Abstrakt

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.

Originalsprog	Engelsk
Artikelnummer	22214
Tidsskrift	Scientific Reports
Vol/bind	11
Udgave nummer	1
Sider (fra-til)	1-13
Antal sider	13
ISSN	2045-2322
DOI	https://doi.org/10.1038/s41598-021-01744-y
Status	Udgivet - 15 nov. 2021

Adgang til dokumentet

10.1038/s41598-021-01744-y

Andre filer og links

Link to publication in Scopus

Citationsformater

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, bind 11, nr. 1, 22214, s. 1-13. https://doi.org/10.1038/s41598-021-01744-y

@article{851288849c004ed1b752bc3bd7faafef,

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

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.",

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",

author = "Rosenstierne, {Maiken W} and Shreya Joshi and Danielsen, {E Thomas} and Helen Webb and Luong, {Dac Mui} and Julie Bjerring and Julie Hindk{\ae}r and L{\ae}rke J{\o}rgensen and Julie Blauenfeldt and Ask Bojesen and Flemming Holck and Lau, {Johnny Weber} and Lars Bangsgaard and Lind, {Jakob Broberg} and Dragheim, {Mette Bjergaard} and Jacobsen, {Mikkel Rohde} and Robert Elkj{\ae}r and Steven Clauwaert and Kristina Christensen and Charlotta Polacek and Anders Fomsgaard and Tuomas Ojalehto and Antti Tullila and Mirko Brummer and Jensen, {Claus Juel} and Jensen, {Frederikke Holm} and Schneider, {Uffe Vest} and Lisby, {Jan Gorm} and J{\o}rgensen, {Rikke Lind} and Thomas Warthoe and Ebbe Finding and Peter Warthoe",

note = "{\textcopyright} 2021. The Author(s).",

year = "2021",

month = nov,

day = "15",

doi = "10.1038/s41598-021-01744-y",

language = "English",

volume = "11",

pages = "1--13",

journal = "Scientific Reports",

issn = "2045-2322",

publisher = "Nature Publishing Group",

number = "1",

}

TY - JOUR

T1 - SARS-CoV-2 detection using reverse transcription strand invasion based amplification and a portable compact size instrument

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

Y1 - 2021/11/15

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.

KW - COVID-19/diagnosis

KW - Cell Phone

KW - Equipment Design

KW - Humans

KW - Mobile Applications

KW - Molecular Diagnostic Techniques/instrumentation

KW - Oropharynx/virology

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

UR - http://www.scopus.com/inward/record.url?scp=85119046251&partnerID=8YFLogxK

U2 - 10.1038/s41598-021-01744-y

DO - 10.1038/s41598-021-01744-y

M3 - Journal article

C2 - 34782681

VL - 11

SP - 1

EP - 13

JO - Scientific Reports

JF - Scientific Reports

SN - 2045-2322

IS - 1

M1 - 22214

ER -

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

Abstrakt

Adgang til dokumentet

Andre filer og links

Fingeraftryk

Citationsformater