Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19 — ERap-COV  

COVID-19 Clinical Trial

Official title: Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19

Status Not yet recruiting

Clinical Trial Summary

Prospective study for clinical performance evaluation of COVID-19 diagnostic tests: detection of anti-SARS-CoV-2 antibodies by RDTs or ELISA (manual or automated), rapid diagnostic tests based on antigen detection, molecular or proteomic testing of SARS-CoV-2 (sensitivity, specificity, predictive values)

Clinical Trial Description

Since initially reported in Wuhan, China, in late December 2019, the outbreak of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) has spread globally, stressing many health systems especially intensive care unit (ICU) capacities thus resulting in high mortality. On 16 March 2020, WHO Director-General called on all countries to ramp up their testing programs as the best way to slow the advance of the coronavirus pandemic. Although the current gold standard for COVID-19 diagnosis remains real time reverse transcription-polymerase chain reaction (rRT-PCR), this technique has many shortcomings such as low sensitivity on nasopharyngeal swabs (70%). Multiple diagnostic test manufacturers have developed and begun selling rapid and easy-to-use devices. Before these tests can be recommended, they must be validated in the appropriate populations and settings.

Funded by French Defense Innovation Agency (AID), ERap-CoV is a prospective clinical study which aims to assess clinical performances of serological and antigenic assays for the diagnosis of SARS-CoV-2 infection, in comparison with current diagnostic tests on the market (immunological, proteomic, molecular). The ERap-CoV research will extend the clinical validation of the first NG-Test IgM-IgG COVID-19 point-of-care immunodiagnostic test (NG Biotech), which has shown excellent biological performance, compatible with the recommendations of the Haute Autorité de Santé (HAS) for serological assays (sensitivity> 90% and specificity> 98%, 15 days after symptoms) (1). Finally, AID funding will be used to develop 100% French-made serological and antigenic RDTs in less than a year. ;

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV 2

• NCT number: NCT04405492
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Thierry Naas
• Phone: +33145212986
• Email: thierry.naas@aphp.fr
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2020
• Completion date: March 25, 2021