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.
Subject(s)
Antibodies, Viral/blood , COVID-19 Serological Testing/methods , COVID-19/diagnosis , Pandemics , SARS-CoV-2/immunology , Asymptomatic Infections , COVID-19 Serological Testing/history , COVID-19 Serological Testing/standards , Forecasting , Health Policy , Health Services Needs and Demand , History, 21st Century , Humans , Immunoglobulin G/blood , Immunoglobulin M/blood , Marketing of Health Services , Politics , Quality Control , Sensitivity and Specificity , United States , United States Food and Drug Administration , Validation Studies as TopicABSTRACT
Antibody tests for detecting past infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have many uses for public health decision making, but demand has largely come from individual consumers. This review focuses on the individual relevance of antibody tests: their accuracy in detecting prior infection, what past SARS-CoV-2 infection can currently infer about future immunity or possible medical sequelae, and the potential future importance of antibody tests for vaccine selection and medical screening. Given uncertainty about the antibody tests (quality, accuracy level, positive predictive value) and what those tests might indicate immunologically (durability of antibodies and necessity for protection from reinfection), seropositive test results should not be used to inform individual decision making, and antibody testing should remain a tool of public health at this time.
Subject(s)
COVID-19 Serological Testing/methods , COVID-19/diagnosis , COVID-19/immunology , SARS-CoV-2/immunology , Decision Making , Humans , Public HealthABSTRACT
From the Webpage: This operational toolkit has been developed to help business owners who are considering reopening or expanding their operations to determine their establishments' risk of transmission of COVID-19 [coronavirus disease 2019] and how to reduce it. As displayed in the figure below, the Operational Toolkit consists of 3 parts: an instruction manual;a business risk worksheet;and an assessment calculator.COVID-19 (Disease);Disaster recovery;Disaster recovery--Plans
ABSTRACT
Recent experiences during a variety of disease outbreaks, ranging from Ebola to influenza, have underscored the potential for epidemics to have an impact on daily life, even for those who are not themselves infected.(1,2) In severe situations, epidemics or pandemics can even affect overall community functioning. For example, a rapidly expanding pandemic can result in shuttered schools, cancelled events, food insecurity, and social distrust in communities. (Am J Public Health. Published online ahead of print May 21, 2020: e1-e2. doi:10.2105/AJPH.2020.305740).