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.
Original language | English (US) |
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Article number | e00201-21 |
Pages (from-to) | 1-12 |
Number of pages | 12 |
Journal | mSphere |
Volume | 6 |
Issue number | 3 |
DOIs | |
State | Published - May 2021 |
Keywords
- COVID-19
- SARS-CoV-2
- diagnostics
- policy
- serology
ASJC Scopus subject areas
- Microbiology
- Molecular Biology