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

Sponsor
Centre Hospitalier Régional d'Orléans (Other)
Overall Status
Completed
CT.gov ID
NCT04609969
Collaborator
(none)
200
Enrollment
1
Location
1
Arm
4
Actual Duration (Days)
1521.9
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: RT-qPCR test
  • Diagnostic Test: COVID-VIRO® test
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Diagnostic
Official Title:
Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test on Nasopharyngeal Specimens i
Actual Study Start Date :
Oct 13, 2020
Actual Primary Completion Date :
Oct 17, 2020
Actual Study Completion Date :
Oct 17, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Diagnostic Test: 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.

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of COVID VIRO® diagnostic specificity [Month 1]

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

  2. Evaluation of COVID VIRO® diagnostic sensitivity [Month 1]

    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

  1. Evaluation of COVID VIRO® diagnostic sensitivity for RT-qPCR Cycle threshold value < or > 28 [Month 1]

    COVID-VIRO® sensitivity is calculated using the RT-qPCR results, restricting for Cycle threshold value

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Régional d'Orléans, France Orléans France 45000

Sponsors and Collaborators

  • Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Thierry PRAZUCK, Dr, CHR ORLEANS

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier:
NCT04609969
Other Study ID Numbers:
  • CHRO-2020-18
First Posted:
Oct 30, 2020
Last Update Posted:
Dec 7, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Régional d'Orléans
SARS-CoV-2 infection
COVID19
Antigen detection test
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Dec 7, 2020