Cargando…
A rapid near-patient RT-PCR test for suspected COVID-19: a study of the diagnostic accuracy
BACKGROUND: Management of large numbers of reverse transcriptase-polymerase chain reactions (RT-PCR) for diagnosis of coronavirus 2019 disease (COVID-19) requires robust infrastructures, located in dedicated premises with a high standard of biosafety procedures, and well-trained personnel. The handl...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
AME Publishing Company
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8263856/ https://www.ncbi.nlm.nih.gov/pubmed/34350236 http://dx.doi.org/10.21037/atm-21-690 |
_version_ | 1783719454724587520 |
---|---|
author | Hofman, Paul Boutros, Jacques Benchetrit, Didier Benzaquen, Jonathan Leroy, Sylvie Tanga, Virginie Bordone, Olivier Allégra, Maryline Lespinet, Virginie Fayada, Julien Maniel, Charlotte Griffonnet, Jennifer Selva, Eric Troncone, Giancarlo Portella, Giuseppe Lavrut, Thibaut Chemla, Richard Carles, Michel Ilié, Marius Marquette, Charles |
author_facet | Hofman, Paul Boutros, Jacques Benchetrit, Didier Benzaquen, Jonathan Leroy, Sylvie Tanga, Virginie Bordone, Olivier Allégra, Maryline Lespinet, Virginie Fayada, Julien Maniel, Charlotte Griffonnet, Jennifer Selva, Eric Troncone, Giancarlo Portella, Giuseppe Lavrut, Thibaut Chemla, Richard Carles, Michel Ilié, Marius Marquette, Charles |
author_sort | Hofman, Paul |
collection | PubMed |
description | BACKGROUND: Management of large numbers of reverse transcriptase-polymerase chain reactions (RT-PCR) for diagnosis of coronavirus 2019 disease (COVID-19) requires robust infrastructures, located in dedicated premises with a high standard of biosafety procedures, and well-trained personnel. The handling of a “run-of-river sample” to obtain rapid reporting of results is challenging. METHODS: We studied the clinical performance of the Idylla™ SARS-CoV-2 Test (index test) on a platform capable of fully automated nucleic acid testing including extraction, amplification, and detection in a single-use cartridge to establish the diagnosis of COVID-19. The study was conducted on a prospective cohort of 112 volunteers with recent symptoms and an unknown SARS-CoV-2 status who came to free screening centers of the Nice metropolitan area. All subjects underwent bilateral nasopharyngeal sampling. One sample was processed using the index test, the other using the standard of care RT-PCR. Samples were treated blind. RESULTS: Most of the participants (70%) were sampled within 4 days of symptom onset. Forty-five (40.2%) were positive for COVID-19. No clinical symptoms were distinguished between SARS-CoV-2 RT-PCR positive and negative subjects except anosmia and dysgeusia. Positive and negative agreement between the index and the standard of care test was 100%. CONCLUSIONS: The Idylla™ SARS-CoV-2 Test is very sensitive, specific, rapid and easy to use in a near-patient RT-PCR approach to distinguish between symptomatic SARS-CoV-2 positive and negative patients in selected settings. |
format | Online Article Text |
id | pubmed-8263856 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | AME Publishing Company |
record_format | MEDLINE/PubMed |
spelling | pubmed-82638562021-08-03 A rapid near-patient RT-PCR test for suspected COVID-19: a study of the diagnostic accuracy Hofman, Paul Boutros, Jacques Benchetrit, Didier Benzaquen, Jonathan Leroy, Sylvie Tanga, Virginie Bordone, Olivier Allégra, Maryline Lespinet, Virginie Fayada, Julien Maniel, Charlotte Griffonnet, Jennifer Selva, Eric Troncone, Giancarlo Portella, Giuseppe Lavrut, Thibaut Chemla, Richard Carles, Michel Ilié, Marius Marquette, Charles Ann Transl Med Original Article BACKGROUND: Management of large numbers of reverse transcriptase-polymerase chain reactions (RT-PCR) for diagnosis of coronavirus 2019 disease (COVID-19) requires robust infrastructures, located in dedicated premises with a high standard of biosafety procedures, and well-trained personnel. The handling of a “run-of-river sample” to obtain rapid reporting of results is challenging. METHODS: We studied the clinical performance of the Idylla™ SARS-CoV-2 Test (index test) on a platform capable of fully automated nucleic acid testing including extraction, amplification, and detection in a single-use cartridge to establish the diagnosis of COVID-19. The study was conducted on a prospective cohort of 112 volunteers with recent symptoms and an unknown SARS-CoV-2 status who came to free screening centers of the Nice metropolitan area. All subjects underwent bilateral nasopharyngeal sampling. One sample was processed using the index test, the other using the standard of care RT-PCR. Samples were treated blind. RESULTS: Most of the participants (70%) were sampled within 4 days of symptom onset. Forty-five (40.2%) were positive for COVID-19. No clinical symptoms were distinguished between SARS-CoV-2 RT-PCR positive and negative subjects except anosmia and dysgeusia. Positive and negative agreement between the index and the standard of care test was 100%. CONCLUSIONS: The Idylla™ SARS-CoV-2 Test is very sensitive, specific, rapid and easy to use in a near-patient RT-PCR approach to distinguish between symptomatic SARS-CoV-2 positive and negative patients in selected settings. AME Publishing Company 2021-06 /pmc/articles/PMC8263856/ /pubmed/34350236 http://dx.doi.org/10.21037/atm-21-690 Text en 2021 Annals of Translational Medicine. All rights reserved. https://creativecommons.org/licenses/by-nc-nd/4.0/Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/) . |
spellingShingle | Original Article Hofman, Paul Boutros, Jacques Benchetrit, Didier Benzaquen, Jonathan Leroy, Sylvie Tanga, Virginie Bordone, Olivier Allégra, Maryline Lespinet, Virginie Fayada, Julien Maniel, Charlotte Griffonnet, Jennifer Selva, Eric Troncone, Giancarlo Portella, Giuseppe Lavrut, Thibaut Chemla, Richard Carles, Michel Ilié, Marius Marquette, Charles A rapid near-patient RT-PCR test for suspected COVID-19: a study of the diagnostic accuracy |
title | A rapid near-patient RT-PCR test for suspected COVID-19: a study of the diagnostic accuracy |
title_full | A rapid near-patient RT-PCR test for suspected COVID-19: a study of the diagnostic accuracy |
title_fullStr | A rapid near-patient RT-PCR test for suspected COVID-19: a study of the diagnostic accuracy |
title_full_unstemmed | A rapid near-patient RT-PCR test for suspected COVID-19: a study of the diagnostic accuracy |
title_short | A rapid near-patient RT-PCR test for suspected COVID-19: a study of the diagnostic accuracy |
title_sort | rapid near-patient rt-pcr test for suspected covid-19: a study of the diagnostic accuracy |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8263856/ https://www.ncbi.nlm.nih.gov/pubmed/34350236 http://dx.doi.org/10.21037/atm-21-690 |
work_keys_str_mv | AT hofmanpaul arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT boutrosjacques arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT benchetritdidier arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT benzaquenjonathan arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT leroysylvie arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT tangavirginie arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT bordoneolivier arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT allegramaryline arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT lespinetvirginie arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT fayadajulien arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT manielcharlotte arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT griffonnetjennifer arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT selvaeric arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT tronconegiancarlo arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT portellagiuseppe arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT lavrutthibaut arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT chemlarichard arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT carlesmichel arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT iliemarius arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT marquettecharles arapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT hofmanpaul rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT boutrosjacques rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT benchetritdidier rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT benzaquenjonathan rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT leroysylvie rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT tangavirginie rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT bordoneolivier rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT allegramaryline rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT lespinetvirginie rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT fayadajulien rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT manielcharlotte rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT griffonnetjennifer rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT selvaeric rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT tronconegiancarlo rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT portellagiuseppe rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT lavrutthibaut rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT chemlarichard rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT carlesmichel rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT iliemarius rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy AT marquettecharles rapidnearpatientrtpcrtestforsuspectedcovid19astudyofthediagnosticaccuracy |