search
Back to results

Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test (COVID-VIRO)

Primary Purpose

Covid19, SARS-CoV-2 Infection

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
RT-qPCR test
COVID-VIRO® test
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid19 focused on measuring SARS-CoV-2 infection, COVID19, Antigen detection test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients (>18 years old) already having a SARS-CoV-2 RT-qPCR positive result within 5 days
  • Adult patients (>18 years old) requiring a SARS-CoV-2 RT-qPCR on nasopharyngeal swab specimen for any reason

Exclusion Criteria:

  • Patients non wishing to participate
  • Under guardianship or curatorship or safeguard of justice patients
  • Inability to join the hospital other than by public transport

Sites / Locations

  • Centre Hospitalier Régional d'Orléans, France

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens

Arm Description

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.

Outcomes

Primary Outcome Measures

Evaluation of COVID VIRO® diagnostic specificity
COVID-VIRO® specificity is calculated using the RT-qPCR results as reference test, according to the following formulas: Specificity (%) = 100 x [Negative / (Negative + Positive)]
Evaluation of COVID VIRO® diagnostic sensitivity
COVID-VIRO® sensitivity is calculated using the RT-qPCR results as reference test, according to the following formulas: Sensitivity (%) = 100 x [Positive/ (Positive + Negative)]

Secondary Outcome Measures

Evaluation of COVID VIRO® diagnostic sensitivity for RT-qPCR Cycle threshold value < or > 28
COVID-VIRO® sensitivity is calculated using the RT-qPCR results, restricting for Cycle threshold value

Full Information

First Posted
October 28, 2020
Last Updated
December 4, 2020
Sponsor
Centre Hospitalier Régional d'Orléans
search

1. Study Identification

Unique Protocol Identification Number
NCT04609969
Brief Title
Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test
Acronym
COVID-VIRO
Official Title
Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test on Nasopharyngeal Specimens i
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
October 17, 2020 (Actual)
Study Completion Date
October 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The current prospective study was designed to assess the diagnostic specificity and sensitivity of a novel antigen-based rapid detection test (COVID-VIRO®) on nasopharyngeal specimens in comparison to the reference test in a real-life setting
Detailed Description
Two nasopharyngeal swab specimens will be concurrently collected on: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, SARS-CoV-2 Infection
Keywords
SARS-CoV-2 infection, COVID19, Antigen detection test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
RT-qPCR test
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
COVID-VIRO® test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of COVID VIRO® diagnostic specificity
Description
COVID-VIRO® specificity is calculated using the RT-qPCR results as reference test, according to the following formulas: Specificity (%) = 100 x [Negative / (Negative + Positive)]
Time Frame
Month 1
Title
Evaluation of COVID VIRO® diagnostic sensitivity
Description
COVID-VIRO® sensitivity is calculated using the RT-qPCR results as reference test, according to the following formulas: Sensitivity (%) = 100 x [Positive/ (Positive + Negative)]
Time Frame
Month 1
Secondary Outcome Measure Information:
Title
Evaluation of COVID VIRO® diagnostic sensitivity for RT-qPCR Cycle threshold value < or > 28
Description
COVID-VIRO® sensitivity is calculated using the RT-qPCR results, restricting for Cycle threshold value
Time Frame
Month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (>18 years old) already having a SARS-CoV-2 RT-qPCR positive result within 5 days Adult patients (>18 years old) requiring a SARS-CoV-2 RT-qPCR on nasopharyngeal swab specimen for any reason Exclusion Criteria: Patients non wishing to participate Under guardianship or curatorship or safeguard of justice patients Inability to join the hospital other than by public transport
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry PRAZUCK, Dr
Organizational Affiliation
CHR ORLEANS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Régional d'Orléans, France
City
Orléans
ZIP/Postal Code
45000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32383182
Citation
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.
Results Reference
background
PubMed Identifier
32302278
Citation
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.
Results Reference
background
Links:
URL
https://covid19.who.int/
Description
WHO coronavirus Dashboard on Sept 15th,2020
URL
https://www.santepubliquefrance.fr/dossiers/coronavirus-covid-19
Description
France Epidemiologic situation on 2020 september 20th

Learn more about this trial

Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test

We'll reach out to this number within 24 hrs