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COVID19 rapid diagnostic tests and humoral response evaluation study
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Study cases
COVERT
COVID19 rapid diagnostic tests and humoral response evaluation study
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Background
FIND, Foundation for Innovative New Diagnostics, is a global non-profit organization driving innovation in the development and delivery of diagnostics to combat major diseases affecting the world’s poorest populations. Within the frame of the COVID19 pandemic crisis, FIND seeks to evaluate rapid serological COVID-19 diagnostic test
Challenges
We are part of an international study coordinated by FIND aiming at evaluating diagnostic performances of rapid diagnostic tests available or close to the market. The rapid point-of-care tests for detection of antibodies against SARSCoV2 have been increasingly integrated into testing strategies around the world but show variable performances,
For this reason, there is a real need from FIND to carefully evaluate these serological tests and to better understand the duration of the antibody response of infected individuals and its association with disease status in order to make recommendation to decision makers and to facilitate public health decisions mainly in developing countries.
Solution
BIOASTER has undertaken 3 different tasks:
- First, we have sourced more than 400 critical clinical samples from SARSCoV2-infected patients without symptoms, and with moderate and severe disease at different time points during the course of the disease. These samples have been collected retrospectively and prospectively in collaboration with clinical centers in France.
- The second phase consisted to perform a head-to-head evaluation of 5 rapid tests using human sera from SARS-CoV2 negative and positive individuals. Results showed that some kits were significantly more performant than other in terms of sensitivity and specificity.
- Finally, we have generated robust scientific data on the association between humoral response and the severity of the disease and on the duration and neutralization capacity of this antibody response in infected patients.
Results
Expected outcome of this project was multiple:
We have demonstrated our capacity to rapidly collect biobanked SARSCoV2 positive and negative samples. Furthermore, a longitudinal prospective study has been setup to monitor patients diagnosed with moderate and severe COVID19 over 11 months.
We have performed a comparison of performance of lateral flow and ELISA serological tests and we have identified the most relevant ones to be recommended by FIND.
We are being finalized the study aiming at demonstrating an association between disease severity and duration and neutralization capacity of humoral response in infected patients.
Outlook
Beyond COVID19 pandemic, BIOASTER will support FIND in the future to develop and evaluate innovative diagnostic solutions for developed countries