Accurate point-of-care serology tests for COVID-19

• Published in: PloS one Vol. 16; no. 3; p. e0248729
• Main Authors: Schuler, Charles F., Gherasim, Carmen, O’Shea, Kelly, Manthei, David M., Chen, Jesse, Giacherio, Don, Troost, Jonathan P., Baldwin, James L., Baker, James R.
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 16.03.2021; Public Library of Science (PLoS)
• Subjects: Adult; Aged; Antibodies; Antibodies, Viral - blood; Biology and Life Sciences; Coronaviruses; COVID-19; COVID-19 - diagnosis; COVID-19 - virology; COVID-19 diagnostic tests; COVID-19 Serological Testing; Data analysis; Diagnosis; Drafting software; Editing; Engineering and Technology; Epidemics; Female; Food allergies; Food hypersensitivity; Funding; Genetic aspects; Humans; Immunoassay; Immunoglobulin G - blood; Immunoglobulin M - blood; Immunology; Infections; Internal medicine; Laboratories; Male; Medical personnel; Medicine; Medicine and Health Sciences; Methodology; Middle Aged; Nanotechnology; Nucleocapsid - immunology; Pandemics; Pathology; Point of care testing; Point-of-Care Systems; Polymerase chain reaction; Reagent Kits, Diagnostic; Research and Analysis Methods; SARS-CoV-2 - immunology; SARS-CoV-2 - isolation & purification; Sensitivity and Specificity; Serodiagnosis; Serology; Severe acute respiratory syndrome; Severe acute respiratory syndrome coronavirus 2; Software; Supervision; United States; Vaccines; Viral diseases; Visualization; Young Adult; United States; Ann Arbor Michigan; United States > US; Michigan
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0248729

As COVID-19 vaccines become available, screening individuals for prior COVID-19 infection and vaccine response in point-of-care (POC) settings has renewed interest. We prospectively screened at-risk individuals for SARS-CoV-2 spike and nucleocapsid protein antibodies in a POC setting to determine if it was a feasible method to identify antibody from prior infection. Three EUA-approved lateral flow antibody assays were performed on POC finger-stick blood and compared with serum and a CLIA nucleocapsid antibody immunoassay. Variables including antibody class, time since PCR, and the assay antigen used were evaluated. 512 subjects enrolled, of which 104 had a COVID-19 history and positive PCR. Only three PCR-positive subjects required hospitalization, with one requiring mechanical ventilation. The POC results correlated well with the immunoassay (93-97% sensitivity) and using serum did not improve the sensitivity or specificity. Finger-stick, POC COVID-19 antibody testing was highly effective in identifying antibody resulting from prior infections in mildly symptomatic subjects. Using high-complexity serum immunoassays did not improve the screening outcome. Almost all individuals with COVID-19 infection produced detectable antibodies to the virus. POC antibody testing is useful as a screen for prior COVID-19 infection, and should be useful in assessing vaccine response.