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Antibody (Serology) Tests for COVID-19: a Case Study.
West, Rachel M; Kobokovich, Amanda; Connell, Nancy; Gronvall, Gigi Kwik.
  • West RM; Johns Hopkins Center for Health Security, Baltimore, Maryland, USA.
  • Kobokovich A; Johns Hopkins Bloomberg School of Public Health, W. Harry Feinstone Department of Molecular Microbiology and Immunology, Baltimore, Maryland, USA.
  • Connell N; Johns Hopkins Center for Health Security, Baltimore, Maryland, USA.
  • Gronvall GK; Johns Hopkins Bloomberg School of Public Health, Department of Environmental Health and Engineering, Baltimore, Maryland, USA.
mSphere ; 6(3)2021 05 12.
Article in English | MEDLINE | ID: covidwho-1226714
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pandemics / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Case report / Diagnostic study / Observational study / Prognostic study Limits: Humans Country/Region as subject: North America Language: English Year: 2021 Document Type: Article Affiliation country: MSphere.00201-21

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pandemics / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Case report / Diagnostic study / Observational study / Prognostic study Limits: Humans Country/Region as subject: North America Language: English Year: 2021 Document Type: Article Affiliation country: MSphere.00201-21