NCT04609969 - Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test | Biotech Hunter

Enrollment

200

Participants

Timeline

Start Date

October 13, 2020

Primary Completion Date

October 17, 2020

Study Completion Date

October 17, 2020

Conditions

Covid19SARS-CoV-2 Infection

Interventions

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.

Trial Locations (1)

45000

Centre Hospitalier Régional d'Orléans, France, Orléans