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

Overview

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

Full Title of Study: “Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test on Nasopharyngeal Specimens i”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Diagnostic
  • Masking: None (Open Label)
• Study Primary Completion Date: October 17, 2020

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 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.

Arms, Groups and Cohorts

• Experimental: Comparison between RT-qPCR and COVID-VIRO® results on nasopharyngeal swab specimens
  • 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.

Clinical Trial Outcome Measures

Primary Measures

• Evaluation of COVID VIRO® diagnostic specificity
  • Time Frame: 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
  • Time Frame: 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 Measures

• Evaluation of COVID VIRO® diagnostic sensitivity for RT-qPCR Cycle threshold value < or > 28
  • Time Frame: Month 1
  • COVID-VIRO® sensitivity is calculated using the RT-qPCR results, restricting for Cycle threshold value

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Centre Hospitalier Régional d’Orléans
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Thierry PRAZUCK, Dr, Principal Investigator, CHR ORLEANS

References

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.

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.