COVID 19 Rapid diagnosis test (development and clinical validation in 7 weeks) – CORaDiag

COVID-19 is an acute respiratory disease caused by novel coronavirus SARS-CoV-2 also known as 2019-nCoV. On March 11, 2020, the World Health Organization (WHO) characterized COVID-19 as a pandemic. The disease is spreading worldwide. The World Health Organization has declared a global health emergency to gather resources and remedy this threat. Early diagnosis is particularly important, not only to prolong the survival of patients, but also to ensure the safety of the population. In the context of the actual pandemia a large-scale screening is urgently needed, especially at the end of containment period and in practitioners and health staff members in charge of people infected by SARS-CoV-2.
To support the efforts in understanding and combating this new health threat, BioSpeedia (spin-off of Pasteur Institute, Paris France), GIMAP Research team (University of Saint-Etienne, University of Lyon) and the University Hospital of St Etienne are collaborating to develop a non-invasive, rapid, cost-efficient and easy to perform antigenic diagnosis test (RDT ConV2Speed), targeting both the Nucleocapsid Protein (N) and the Spike Protein (S) of SARS-CoV-2.
The two succesive steps of the project are a technical optimization and a clinical evaluation. For the latter, a total of 100 informed participants with suspected SARS-CoV-2 infection and a total of informed 100 non infected patients will be prospectively enrolled in the clinical trial for diagnosis. RT-PCR protocol developped by Pasteur Institute (targeting IP-2, IP-4 and E genes) and used on routine basisin our Lab will be taken as gold standard. Sensitivity and specificity of our antigenic assay will be established first by using nasopharyngeal swab samples. In a second time, we plan to test our device on pulmonary secretions and urine samples.
This antigenic semi-quantitative SARS-CoV-2 direct rapid test for screening people infected with a high viral load would be of high interest if it could be done outside labs in order to recognize people considered as "super-spreaders".
The RDT ConV2Speed could be ready in April 2020 if the project is funded end of March 2020.