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

Centre Hospitalier Régional d'Orléans

Status: Completed

Conditions: SARS-CoV-2 Infection; Covid19

Treatments: Diagnostic Test: RT-qPCR test; Diagnostic Test: COVID-VIRO® test

Study type: Interventional

Funder types: Other

Identifiers

NCT04609969

CHRO-2020-18

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

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

Experimental group

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.

Treatment:

Diagnostic Test: COVID-VIRO® test

Diagnostic Test: RT-qPCR test