Stanford's David Studdert and Mark Hall of Wake Forest University Schools of Law and Medicine write in this JAMA Viewpoint that the coming surge in COVID-19 immunity testing likely will lead to people beginning to self-certify, with much less accuracy and credibility than if certification were official. The rapidly unfolding situation raises a host of important legal, ethical, and policy concerns that will not wait for greater scientific certainty.
"As the coronavirus disease 2019 (COVID-19) crisis enters its next phase, attention turns to the widespread testing programs needed to resume and maintain normal life activities. Effective prevention and surveillance require testing for active infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and for antibodies that indicate prior infection and potential immunity. There is an established approach for infected individuals: mild cases self-isolate; and severe cases receive treatment. But what is the appropriate response for people with positive antibody tests?
"Some European countries are considering serological tests to issue immunity certifications (passports) that give holders certain time-limited work and social freedoms, joining larger gatherings or returning to nonessential jobs, and the US government is considering similar proposals. Certifications commonly form part of infection control strategies in other settings; eg, states prescribe vaccine requirements for childcare and health care workers. Public health screening programs require schoolteachers prove they do not have tuberculosis. Many countries require visitors to show a yellow fever vaccination certificate.
"However, an immunity certificate program for COVID-19 would be unparalleled in several ways. First, because COVID-19 is not (yet) vaccine-preventable, inoculation must come entirely from prior infection. Second, the program likely would apply more broadly than to only a handful of selected professions or activities. Third, the conditioned “privileges” could include a greater range of fundamental civil liberties and opportunities, like freedom of association, worship, work, education, and travel. In addition, scientific understanding of SARS-CoV-2 immunity is still fairly rudimentary. How much immunity infection confers, and for how long, is unknown, as is the level and type of antibodies that indicate immunity.
"Ideally, clearer scientific understanding and careful deliberation would precede any public or private policy that selectively relaxes restrictions based on positive tests for SARS-CoV-2 antibodies. However, the ideal of a measured, evidence-based approach to policy making appears likely to be overrun by hopes and demands for antibody testing. Antibody tests are proliferating. Following the slow and inefficient roll-out of viral testing, the US Food and Drug Administration (FDA) initially announced that antibody tests could be marketed without prior approval so long as users receive appropriate disclaimers. The agency recently amended its stance to permit preapproval distribution by commercial manufacturers only while seeking FDA approval. Under this permissive approach, dozens of unproven antibody tests, many manufactured in other countries, are now available and being marketed aggressively."