DAVINCI- Development and Validation of a Lateral Flow Test to Detect COVID-19 Antigens and Immunity in Saliva

The COVID-19 pandemic has led to shutdowns and home isolation of more than half of the world’s population resulting in severe economic impact. This research project addresses the current crucial need to develop an innovative easy-to-use diagnostic test designed for consumers at home, which addresses all relevant diagnostic questions for COVID-19 in one single test device.  Specifically, the project aims to develop and validate a disposable rapid test device to detect SARS-CoV-2 antigens and antibodies in saliva samples within 15 minutes.

The DAVINCI consortium will develop and validate a simple, inexpensive and accurate rapid diagnostic test device for detecting antigens and antibodies in saliva samples. Currently, COVID-19 tests are based on nasopharyngeal swabs (antigen tests) and blood samples (antibodies), which require trained medical personnel and cannot be performed at home. The project addresses the innovation of combining antigen-antibody detection using non-invasive samples for individual home use:

• The test informs on the contagiousness and immune status of the user, and supports decisions on adequate preventive measures and/or access control to transportation services (air, sea, land), sports and culture events, schools, universities and work locations.
• The test enables individual self-testing at home in case of symptoms, after exposure to close contacts or to assess contagiousness.
• The associated App, which displays the test result, can serve as a digital “passport” for the user’s COVID-19 status or proof of recent exposure or seroconversion for travellers entering different countries (as an alternative to a vaccination certificate).
• Following a COVID-19 vaccination, the DAVINCI antibody test readout has the potential to document a vaccine-associated seroconversion if vaccination is based on the SARS-CoV-2 spike protein.

The DAVINCI project will develop and evaluate an innovative, all-integrated rapid diagnostic test kit based on saliva. The test is designed for non-professional use at home and is linked to a smartphone App for capturing and processing the test results. This disposable test will be validated in a cohort of well-characterised COVID-19 exposed and unexposed individuals over a broad diagnostic time window using reference comparator diagnostics in blood and saliva. The test kit can be adapted and developed further for other infectious diseases (i.e., influenza), and thus holds big potential to contribute towards improving health care during this pandemic and beyond.

Image: The research aims to develop and validate a disposable rapid test device to detect SARS-CoV-2 antigens and antibodies in saliva samples within 15 minutes.