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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:
Specificity and sensitivity are assessed in comparison to real-time RT-qPCR results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RT-qPCR test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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)] | 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)] | Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Month 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry PRAZUCK, Dr | CHR ORLEANS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Régional d'Orléans, France | Orléans | 45000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32383182 | Background | Drame M, Tabue Teguo M, Proye E, Hequet F, Hentzien M, Kanagaratnam L, Godaert L. Should RT-PCR be considered a gold standard in the diagnosis of COVID-19? J Med Virol. 2020 Nov;92(11):2312-2313. doi: 10.1002/jmv.25996. Epub 2020 Jul 14. No abstract available. | |
| 32302278 | Background | Zitek T. The Appropriate Use of Testing for COVID-19. West J Emerg Med. 2020 Apr 13;21(3):470-472. doi: 10.5811/westjem.2020.4.47370. |
| Label | URL |
|---|---|
| WHO coronavirus Dashboard on Sept 15th,2020 | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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.
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|
| COVID-VIRO® test | Diagnostic 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. |
|
| France Epidemiologic situation on 2020 september 20th | View source |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |