Covid19 Clinical Trial
— COVID-VIROOfficial title:
Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test on Nasopharyngeal Specimens i
| Verified date | December 2020 |
| Source | Centre Hospitalier Régional d'Orléans |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | October 17, 2020 |
| Est. primary completion date | October 17, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Régional d'Orléans, France | Orléans |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Régional d'Orléans |
France,
Dramé 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 May 8. doi: 10.1002/jmv.25996. [Epub ahead of print] — View Citation
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. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Secondary | 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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