Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test
NCT ID: NCT04609969
Last Updated: 2020-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2020-10-13
2020-10-17
Brief Summary
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Detailed Description
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* adult patients hospitalized in the Infectious Diseases Department of the Centre Hospitalier Régional d'Orléans (CHRO) for confirmed SARS-CoV-2 infection,
* or symptomatic or asymptomatic subjects voluntarily accessing the COVID-19 Screening Department of the CHRO to perform a diagnostic test. COVID VIRO® diagnostic.
Specificity and sensitivity are assessed in comparison to real-time RT-qPCR results.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens
Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.
RT-qPCR test
Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.
COVID-VIRO® test
Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.
Interventions
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RT-qPCR test
Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.
COVID-VIRO® test
Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.
Eligibility Criteria
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Inclusion Criteria
* Adult patients (\>18 years old) requiring a SARS-CoV-2 RT-qPCR on nasopharyngeal swab specimen for any reason
Exclusion Criteria
* Under guardianship or curatorship or safeguard of justice patients
* Inability to join the hospital other than by public transport
18 Years
ALL
No
Sponsors
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Centre Hospitalier Régional d'Orléans
OTHER
Responsible Party
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Principal Investigators
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Thierry PRAZUCK, Dr
Role: PRINCIPAL_INVESTIGATOR
CHR ORLEANS
Locations
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Centre Hospitalier Régional d'Orléans, France
Orléans, , France
Countries
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References
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Drame M, Tabue Teguo M, Proye E, Hequet F, Hentzien M, Kanagaratnam L, Godaert L. Should RT-PCR be considered a gold standard in the diagnosis of COVID-19? J Med Virol. 2020 Nov;92(11):2312-2313. doi: 10.1002/jmv.25996. Epub 2020 Jul 14. No abstract available.
Zitek T. The Appropriate Use of Testing for COVID-19. West J Emerg Med. 2020 Apr 13;21(3):470-472. doi: 10.5811/westjem.2020.4.47370.
Related Links
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WHO coronavirus Dashboard on Sept 15th,2020
France Epidemiologic situation on 2020 september 20th
Other Identifiers
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CHRO-2020-18
Identifier Type: -
Identifier Source: org_study_id