![]() Nonetheless, poor-quality tests remained in use, potentially giving individuals false medical information that could increase their risk of contracting COVID-19. After 7 weeks, and after Congressional inquiries in response to reports of consumer fraud, FDA regulatory measures were made more stringent. Their initial regulatory approach, however, created a situation where many unvalidated, low-quality tests flooded the market. The FDA took steps that were encouraging to manufacturers to produce serology tests. The potential for convalescent plasma for use as a therapy was also dependent on donors who were recovered from COVID-19, often measured by seropositivity ( 10). There was great demand for the tests from individuals who wanted to know if they had already been infected, perhaps asymptomatically, and could therefore avoid restrictive public health measures. Despite the immunological uncertainties, antibody tests were described by political leaders as a tool to “open up the economy” and return to “normal” life-even before such tests were available. In the early days of the pandemic, there was much more uncertainty about whether people who had recovered from SARS-CoV-2 were immune, or whether they could be reinfected. It is not recommended for those who are seropositive to exempt themselves from social distancing or mask use, and they are currently recommended to be vaccinated to protect against COVID-19 ( 8, 9). However, it remains uncertain how long immunity persists, and what level of antibodies (titer) is sufficient for immunity. Past infection with SARS-CoV-2 is thought to provide some immunity from COVID-19 disease. The meaning of SARS-CoV-2 seropositivity for individual patients remains unclear ( 6). Though it is possible that a person who tests positive with a serology test may still be infectious, serology tests should not be used to diagnose current infections ( 5). ![]() Serology tests typically measure IgM antibodies specific to the virus, which form 5 to 10 days after initial infection, and/or IgG antibodies, which form 7 to 10 or more days after initial infection ( 3, 4). Serology tests are used to detect patient antibodies specific to SARS-CoV-2, and the presence of anti-SARS-CoV-2 antibodies (seropositivity) can indicate prior infection ( 1, 2). This paper focuses on the development, marketing, and regulation of serology (antibody) tests for COVID-19 in the United States and offers specific recommendations for future health security crises. AN EXAMPLE OF INSUFFICIENT REGULATION AND HIGH CONSUMER DEMAND
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