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

Not Applicable

Completed

• Conditions: Covid19; SARS-CoV-2 Infection
• Interventions: Diagnostic Test: RT-qPCR test; Diagnostic Test: COVID-VIRO® test

• Registration Number: NCT04609969
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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.

Study Timeline

• Study Start: 2020-10-13
• Primary Completion: 2020-10-17
• Study Completion: 2020-10-17
• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-10-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-04
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens	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.
Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens	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.

Primary Outcome Measures

Name	Time	Method
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 \[Positive/ (Positive + Negative)\]
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 \[Negative / (Negative + Positive)\]

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Hospitalier Régional d'Orléans, France; 🇫🇷 Orléans, France