Serology (antibody) tests to detect previous SARS-CoV-2 infection have been in high demand from the beginning of the COVID-19 pandemic. The initial shortage of diagnostic tests coupled with asymptomatic infections led to a significant demand for serology tests to identify past infections. ABSTRACT Serology (antibody) tests to detect previous SARS-CoV-2 infection have been in high demand from the beginning of the COVID-19 pandemic. The initial shortage of diagnostic tests coupled with asymptomatic infections led to a significant demand for serology tests to identify past infections. Despite serious limitations on the interpretation of a positive antibody test in terms of immunity to SARS-CoV-2, antibody testing was initially considered for release from social distancing, return to employment, and “immunity passports.” The regulatory approach to antibody tests was limited; manufacturers were encouraged to develop and market antibody tests without submitting validation data to the FDA. FDA guidance grew more stringent, but many poor-quality tests were already on the market—potentially inappropriately used for individual decision-making. This is a case study describing COVID-19 serology tests and the U.S. market and describes lessons learned for a future health security crisis.
【저자키워드】 COVID-19, SARS-CoV-2, serology, diagnostics, Policy, 【초록키워드】 Antibody testing, Immunity, serology, antibody, social distancing, SARS-COV-2 infection, COVID-19 pandemic, diagnostic test, FDA, asymptomatic infections, Regulatory, Health, infections, serology tests, antibody tests, diagnostic tests, Interpretation, asymptomatic infection, serology test, Antibody test, case study, Guidance, employment, market, limitation, positive, approach, Immunity passports, initial, identify, detect, develop, 【제목키워드】 Test,