1. Development and evaluation of low-volume tests to detect and characterize antibodies to SARS-CoV-2.
- Author
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Halliday, Alice, Long, Anna E., Baum, Holly E., Thomas, Amy C., Shelley, Kathryn L., Oliver, Elizabeth, Gupta, Kapil, Francis, Ore, Kavanagh Williamson, Maia, Di Bartolo, Natalie, Randell, Matthew J., Ben-Khoud, Yassin, Kelland, Ilana, Mortimer, Georgina, Ball, Olivia, Plumptre, Charlie, Chandler, Kyla, Obst, Ulrike, Secchi, Massimiliano, and Piemonti, Lorenzo
- Subjects
SARS-CoV-2 ,IMMUNOGLOBULINS ,COVID-19 ,COVID-19 pandemic ,DIAGNOSTIC use of polymerase chain reaction - Abstract
Low-volume antibody assays can be used to track SARS-CoV-2 infection rates in settings where active testing for virus is limited and remote sampling is optimal. We developed 12 ELISAs detecting total or antibody isotypes to SARS-CoV-2 nucleocapsid, spike protein or its receptor binding domain (RBD), 3 anti-RBD isotype specific luciferase immunoprecipitation system (LIPS) assays and a novel Spike-RBD bridging LIPS total-antibody assay. We utilized pre-pandemic (n=984) and confirmed/suspected recent COVID-19 sera taken pre-vaccination rollout in 2020 (n=269). Assays measuring total antibody discriminated best between pre-pandemic and COVID-19 sera and were selected for diagnostic evaluation. In the blind evaluation, two of these assays (Spike Pan ELISA and Spike-RBD Bridging LIPS assay) demonstrated >97% specificity and >92% sensitivity for samples from COVID-19 patients taken >21 days post symptom onset or PCR test. These assays offered better sensitivity for the detection of COVID-19 cases than a commercial assay which requires 100-fold larger serum volumes. This study demonstrates that low-volume in-house antibody assays can provide good diagnostic performance, and highlights the importance of using well-characterized samples and controls for all stages of assay development and evaluation. These cost-effective assays may be particularly useful for seroprevalence studies in low and middle-income countries. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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