Development of a novel, rapid and safe neutralising antibody diagnostic kit by The Native Antigen Company

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Diagnostic tests are a vital component of disease diagnosis and vaccine research. For any test,the important parameters are sensitivity (i.e. the ability of the test to correctly identify apositive sample) and specificity (i.e. its ability to discriminate correctly between differentdiseases). Most diagnostic tests are simple plate-based assays or pregnancy test-type assays –cheap and easy to run in most labs or GP surgeries, but often suffer from poor sensitivity andspecificity. For example, tests for Chlamydia pneumonia can be false positive if genitalChlamydia trachomatis is present, and dengue virus tests come up positive for West Nile virusand tick-borne encephalitis. Plaque reduction neutralisation tests (PRNTs) get around thesecross-reactivity problems, and are currently the gold standard diagnostic test, but they use livepathogens that are often extremely hazardous to handle and can take up to 10 days to perform.This means they can only be done in rare specialised laboratories and have a high cost pertest. PRNTs are also used in vaccine research, where the number of neutralising antibodies isused as a measure for how efficacious a vaccine is. Having to perform these tests in highbiocontainment facilities raises the cost of vaccine research and the speed to develop asuccessful vaccine. Our novel test is designed to provide the specificity and sensitivity of aPRNT, but with 100% safe reagents and taking only 1 day to perform. We believe this wouldbe of great help to improve diagnosis for many human and animal diseases and to enable andenhance vaccine research into hazardous pathogens.