Abstract
Are Lessons Learned in Setting Cut Points for Detection of Anti-Drug Antibodies Also Useful in Serology Assays for Robust Detection of SARS-CoV-2 Reactive Antibodies?
Highlights
The current COVID-19 global pandemic has generated widespread interest across clinical, research, academic, and governmental laboratories, as well as at Biopharma companies for the application of in vitro diagnostic assays to detect the presence of SARS-CoV-2 virus or to characterize the emergence of an adaptive immune response against this virus
Unlike molecular diagnostic and viral antigen tests that detect an active viral infection, serological assays detect serum antibodies to SARS-CoV-2 viral antigens in individuals who have exhibited an adaptive immune response as part of either an active or prior infection [3]
Because the reliability of serological assays remains a topic of concern to both the scientific community and general public, the FDA issued an updated policy on May 4, 2020 that required antibody test manufacturers to submit an Emergency Use Authorization (EUA) request within 10 business days [1]
Summary
Oversight by FDA with lab work conducted under The Centers for Medicare and Medicaid Services. GCP/GLP bioanalysis as outlined in guidance docu- (CMS) regulates all clinical lab testing performed on ments with the most recent being published in humans in the USA through Clinical Lab Improvement. Whenever individuals seek diagnostic verification for post-approval the development of an adaptive immune response to the SARS-CoV-2 virus
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