Antibody (Serology) Tests for COVID-19: a Case Study.
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.
Keywords
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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