Covid19, SARS-CoV-2 Infection
Conditions
Keywords
SARS-CoV-2 infection, COVID19, Antigen detection test
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.
Interventions
DIAGNOSTIC_TESTRT-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_TESTCOVID-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.
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 \[Negative / (Negative + Positive)\] |
| 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 \[Positive/ (Positive + Negative)\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed