Development and Validation of a Lateral Flow Immuno-Assay to Diagnose Covid-19 in Saliva (DAVINCI)

Project Description

Goal:

The DAVINCI consortium developed and validated a test, suitable for home use, that uses saliva samples to identify the presence of SARS-CoV-2 antigens and antibodies. The test can therefore simultaneously inform the user whether they are currently infected with the COVID-19 virus and whether they have had prior exposure to the virus. A smartphone app was also developed to support the test user.

Timeframe:

July 2020 – July 2022

Lead researcher(s):

Prof Daniel Paris, Dr Daniel Richards, Dr Stefan Stubinger

The Need for Antibody Tests to Provide Information about COVID-19 Exposure

Following the identification of the COVID-19 causing SARS-CoV-2 virus, diagnostic tests were made
quickly available. These tests were crucial for detecting active infections and therefore enabling
targeted management of virus spread. However, there was also an urgent need for tests which could
identify the presence of COVID-19-specific antibodies and thereby provide information about the
degree of COVID-19 exposure within the population so far. This information was crucial for
accurately informing public health organisations about the extent of the outbreak, and helping
scientists to answer basic questions, such as:

  • How many people have been infected with the virus?
  • Who may have spread it without knowing?
  • How deadly is COVID-19?
  • What measures are needed to slow its spread?

Antibody tests most commonly use a blood sampling method. However, this consortium, led by Prof
Daniel Paris recognised that there would be significant value in developing a test which identifies the
presence of COVID-19 antibodies in saliva. Saliva is often referred to as a ‘mirror of the body.’ Like
blood, saliva contains proteins, DNA and RNA that can be assessed for abnormalities and diseases.
Unlike blood-based tests, it is easy for people to carry out saliva-based tests in their own homes.

A New Saliva-Based Test to Identify Antigens and Antibodies

The consortium developed and validated a test, suitable for home use, that uses saliva samples to
identify the presence of SARS-CoV-2 antigens (indicating current infection) and antibodies (indicating
prior exposure to the virus and potentially a degree of immunity). The use of the test requires that
the user spits into a device funnel. After 12 minutes, the device displays the result as test lines similar
to those displayed on a pregnancy test.
In addition, the consortium developed an app for iOS and Android that takes a step-by-step approach
to guiding the user through the sampling and measurement processes. A key feature of the app is
that it can evaluate and interpret the test results from a picture of the device after test completion.
Using bespoke image recognition code, the app identifies unique window and casing markers and
uses these to orient the images and locate the test and control lines. The code subsequently analyses
the test lines and ultimately determines the result of the test. The app also allows for user
registration and storage of past results, enabling the user to track results over time.

A Wide Range of Potential Applications for the Test

The device developed in the DAVINCI project was the first testing platform which uses only saliva and
no additional reagents. It does not require additional specialist equipment or personnel and

therefore has a wide range of potential uses, for example in low- and middle-income countries, in
people’s homes and for the testing of large groups of people, such as at events.  Beyond COVID-19 it
holds promise for a range of other diseases for which antibodies and antigens can be identified using
saliva samples, for example, dengue virus and influenza.

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