Accurate point-of-care serology tests for COVID-19
Open Access
- 16 March 2021
- journal article
- research article
- Published by Public Library of Science (PLoS) in PLOS ONE
- Vol. 16 (3), e0248729
- https://doi.org/10.1371/journal.pone.0248729
Abstract
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.Funding Information
- Healgen Scientific
- Access Bio Inc
- University of Michigan (COVID 19 Innovation Award)
- National Institutes of Health (UL1TR002240)
This publication has 17 references indexed in Scilit:
- Differences in Performance Characteristics Among Four High-Throughput Assays for the Detection of Antibodies Against SARS-CoV-2 Using a Common Set of Patient SamplesAmerican Journal of Clinical Pathology, 2020
- Coronavirus Disease 2019–COVID-19Clinical Microbiology Reviews, 2020
- COVID-19 herd immunity: where are we?Nature Reviews Immunology, 2020
- Immunological considerations for COVID-19 vaccine strategiesNature Reviews Immunology, 2020
- The Rapid Coronavirus Antibody Test: Can We Improve Accuracy?Frontiers in Medicine, 2020
- Evaluation of three immunochromatographic tests for rapid detection of antibodies against SARS-CoV-2European Journal of Clinical Microbiology & Infectious Diseases, 2020
- Disease Control, Civil Liberties, and Mass Testing — Calibrating Restrictions during the Covid-19 PandemicThe New England Journal of Medicine, 2020
- Immune Response, Inflammation, and the Clinical Spectrum of COVID-19Frontiers in Immunology, 2020
- Psychosocial impact of COVID-19Diabetes & Metabolic Syndrome: Clinical Research & Reviews, 2020
- SARS-CoV-2 and COVID-19: The most important research questionsCell & Bioscience, 2020