Are Lessons Learned in Setting Cut Points for Detection of Anti-Drug Antibodies Also Useful in Serology Assays for Robus
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Commentary 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? Ronald R. Bowsher1,4 and Viswanath Devanarayan2,3
Received 20 July 2020; accepted 8 September 2020
KEY WORDS: COVID-19; cut point; diagnostics; immunogenicity; serology; statistics.
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. Following declaration of the COVID-19 public health emergency by Alex Azar, Secretary of Health and Human Services, on Jan. 31, 2020, the FDA issued an “immediatein-effect” guidance on 29 February to make in vitro diagnostic tests available by Emergency Use Authorization (EUA) to address the urgent need for IVD tests to support diagnosis and treatment of COVID-19 infections (1). Subsequently in late April, the FDA released the umbrella EUA guidance to offer an additional route for expediting approval and market availability of serological tests for COVID-19 (2). 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). As such, serology tests offer the potential to verify that individuals, who had a prior SARS-CoV-2 infection with clinical symptoms or who have remained asymptomatic, developed a humoral antibody response. Despite their perceived value, commercial serology assays, point-of-care devices, and homebrew laboratory developed tests (LDTs) vary appreciably with respect to their design attributes and performance capabilities. Consequently, serological assays are known to demonstrate inconsistency in antibody detection due to differences in their clinical sensitivity 1
B2S Life Sciences llc, 97 East Monroe Street, Franklin, Indiana 46131, USA. 2 GlaxoSmithKline, 1250 South Collegeville Road, Collegeville, Pennsylvania 19426, USA. 3 University of Illinois at Chicago, 1200 W. Harrison Street, Chicago, Illinois 60607, USA. 4 To whom correspondence should be addressed. (e–mail: [email protected]), URL: https:// www.B2SLifeSciences.com
and specificity (4). For example, recent evidence suggests that some assays may be prone to false-positive results due to the presence of serum antibodies against other coronaviruses that are also crossreactive to structurally homologous epitopes present in the SARSCoV-2 virus (5–7). While at present the overall value of serological testing remains unclear (8), this technology will undoubtedly find broad application in epidemiological surveillance studies, contact tracing, and in evaluating antigen-specific humoral immunity after active immunization (4,9,1
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