In response to coronavirus disease 2019 (COVID-19), governments have instigated rules that constrain personal freedoms and hamstring their own economies, placing approximately 3 billion people under lockdown. Some have rolled out widespread testing for current infections, while others limited these tests to people who were hospitalised, atleast during the early stages of their responses. As new controls begin to bite, the race to develop and approve a test with a different purpose—to assess not current viral infection, but immunity to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)—has heated up. Medical diagnostic companies are scrambling, and governments are looking to order these antibody tests by the millions.
The task now facing governments and national regulators is to balance urgency against the everyday sensitivity and specificity concerns that apply to any new medical diagnostic. A few technical questions still exist around optimising test design, primarily hinging on understanding how the viral coating triggers a healthy immune system's recognition and neutralisation of the virus. Yet, there is a palpable hurry to limit economic damage, to get people back to work, and to reopen borders—and those whose immunity can be demonstrated should be able to return to work, without risk. Some regulators, such as the US Food & Drug Administration (FDA), have already chosen to relax normal assessment criteria.
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