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

Centre Hospitalier Régional d'Orléans200 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

200

Conditions

Covid19 SARS-CoV-2 Infection

Interventions

RT-qPCR testDIAGNOSTIC_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® testDIAGNOSTIC_TEST

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier Régional d'Orléans, France

Orléans, France

Outcomes

Primary Outcomes

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 \[Negative / (Negative + Positive)\]

Time frame: Month 1

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 \[Positive/ (Positive + Negative)\]

Time frame: Month 1

Secondary Outcomes

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

Time frame: Month 1

Data from ClinicalTrials.gov

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