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

被引:7
|
作者
Rosenstierne, Maiken W. [1 ,2 ]
Joshi, Shreya [1 ]
Danielsen, E. Thomas [1 ]
Webb, Helen [1 ]
Dac Mui Luong [1 ]
Bjerring, Julie [1 ]
Hindkaer, Julie [1 ]
Jorgensen, Laerke [1 ]
Blauenfeldt, Julie [1 ]
Bojesen, Ask [1 ]
Holck, Flemming [1 ]
Lau, Johnny Weber [1 ]
Bangsgaard, Lars [1 ]
Lind, Jakob Broberg [1 ]
Dragheim, Mette Bjergaard [1 ]
Jacobsen, Mikkel Rohde [1 ]
Elkjaer, Robert [1 ]
Clauwaert, Steven [1 ]
Christensen, Kristina [1 ]
Polacek, Charlotta [2 ]
Fomsgaard, Anders [2 ]
Ojalehto, Tuomas [3 ]
Tullila, Antti [3 ]
Brummer, Mirko [3 ]
Jensen, Claus Juel [4 ]
Jensen, Frederikke Holm [5 ]
Schneider, Uffe Vest [5 ]
Lisby, Jan Gorm [5 ]
Jorgensen, Rikke Lind [5 ]
Warthoe, Thomas [1 ]
Finding, Ebbe [1 ]
Warthoe, Peter [1 ]
机构
[1] Qlife, Borupvang 3,2750 Ballerup & Symbion, DK-2100 Copenhagen, Denmark
[2] Statens Serum Inst, Dept Virus & Microbiol Special Diagnost, Artillerivej 5, DK-2300 Copenhagen, Denmark
[3] Aidian Oy, Espoo, Finland
[4] Nordsjaellands Hosp, Klin Biokem Afdeling, Dyrehavevej 29, DK-3400 Hillerod, Denmark
[5] Amager & Hvidovre Hosp, Klin Mikrobiol Afdeling, Afsnit 445,Kettegard Alle 30, DK-2650 Hvidovre, Denmark
关键词
MEDIATED ISOTHERMAL AMPLIFICATION;
D O I
10.1038/s41598-021-01744-y
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
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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页数:13
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