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Completed

NCT Number: NCT04609969

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

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV-2 Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Régional d'Orléans, France

Orléans, 45000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RT-qPCR test

Diagnostic 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

Diagnostic 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.

Primary outcomes

  1. Evaluation of COVID VIRO® diagnostic specificity

    Time frame: 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

    Time frame: 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 outcomes

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

    Time frame: Month 1

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: COVID-VIRO

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 30, 2020
Registry last updated
Dec 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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