A rapidly scalable, differentiated COVID-19 antibody/immunity test for mass-testing: proof of concept.

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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.