There is no easily accessible COVID-19/SARS-CoV-2 antibody test with adequate sensitivity and specificity. This hampers diagnosis, contact tracing and policy decisions. We have initiated the development of 2 targeted mass spectrometry (MS) antibody tests for mass-testing and vaccine development. These saliva and plasma tests are rapidly scalable, automated, can be transferred and standardised across multiple instruments, manufacturers and laboratories, providing an achievable 100,000 tests/day capacity. To our knowledge, this is the first targeted mass spectrometry test for SARS-CoV-2 antibodies. The test is complementary to other technology platforms (immunoassays, point-of-care tests) as it uses a different set of consumables, instrumentation, laboratories and scientists with different skill sets. This expands the UK's antibody testing capacity under UK government's testing strategy Pillar 3 and 5, whilst delivering more accurate results within the same cost ballpark. The test has high inherent specificity and sensitivity in contrast to existing tests, reducing the false positive and false negative rate. In addition to commonly measured elements (IgM and IgG antibodies), the test also measures elements which have a stronger correlation with neutralising antibody levels (which confer protection from the disease) at the same time. The results show how much of the antibodies are present in contrast to a binary (positive/negative) readout, which may become particularly important if it emerges that antibody concentration correlates with the degree of immunity conferred. Saliva samples utilised in this test simplify and broaden access to antibody tests as these samples can be collected at home. Our vision is the test's application to vaccine development and mass-testing in the UK and US, rolled out this autumn from several central laboratories which is how mass PCR-testing is conducted currently. Innovate UK funding will allow us to validate our differentiated antibody tests to published Target Product Profiles and work with Public Health England and vaccine developers to ensure adoption of this test. Once this test is set up, it can be readily adapted to mutated SARS-COV-2 or different viruses for the upcoming winter season and future outbreaks.

Our innovation is the development of a new test for COVID-19/SARS-CoV-2 human antibodies to detect immunity. The test is rapidly scalable, highly automated, can be readily transferred and standardised across multiple instruments, manufacturers and laboratories. It has high inherent specificity and sensitivity in contrast to existing tests, reducing the false positive and false negative rate. To our knowledge, this is the first targeted mass spectrometry test for SARS-CoV-2 immunity. The test is also complementary to existing point-of-care and future immunoassays as it uses different set of consumables, instrumentation, laboratories and scientists with different skillsets. This expands the UK's immunity testing capacity under UK government's testing strategy Pillar 3 and 5\. Our vision is the test's application to vaccine development and mass-testing in the UK and US, rolled out this summer from several central laboratories which is how mass PCR-testing is conducted currently. The key objectives of the project include implementing this test in one of our laboratories and assessing its diagnostic accuracy and reliability using confirmed COVID-19 blood samples. This would enable us to work with Public Health England (_PHE_) or Innovative New Diagnostics foundation (FIND) to assess the performance of this test in a larger cohort of samples, including asymptomatic and mildly symptomatic cases, ahead of adoption for mass-testing. The focus of this project is to demonstrate our method is capable of quantifying human SARS-CoV-2 antibody levels and meets diagnostic and technical performance metrics in the initial cohort of blood samples. Once this test is set up, it can be readily adapted to other antigens/coronaviruses for future outbreaks. Due to the high level of automation the costs of this test reduce significantly upon scaling, meaning it is well suited to cost-effective mass testing. We will also adapt this platform to develop other clinical tests in other disease areas.