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.
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.
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
Centre Hospitalier Régional d'Orléans, France
Orléans, France
Thierry PRAZUCK, Dr, Principal Investigator
CHR ORLEANS