期刊
FRONTIERS IN IMMUNOLOGY
卷 13, 期 -, 页码 -出版社
FRONTIERS MEDIA SA
DOI: 10.3389/fimmu.2022.968317
关键词
antibody; diagnostic; ELISA; evaluation; SARS-CoV-2; COVID-19; immunity; luciferase immunoprecipitation system (LIPS)
类别
资金
- Elizabeth Blackwell Institute
- Wellcome Trust [204813/Z/16/Z, 217509/Z/19/Z, 202802/Z/16/Z, 106115/Z/14/Z, 221708/Z/20/Z]
- Diabetes UK/JDRF RD Lawrence Fellowship [18/0005778, 3-APF-2018-591-A-N]
- Southmead Hospital Charity [1055900]
- Grand Appeal (The Official Bristol Children's Hospital Charity) [1043603]
- UKRI through the JUNIPER consortium [MR/V038613/1]
- CoMMinS study [MR/V028545/1]
- University of Bristol NIHR Biomedical Research Centre [BRC-1215-2001]
- MRC Integrative Epidemiology Unit [MC_UU_00011/1]
- CRUK Integrative Cancer Epidemiology Programme [C18281/A29019]
- Diabetes UK/JDRF [20/0006217]
- ERC [834631, 963992]
- EPSRC Impact Acceleration Account [EP/R511663/1]
- BBSRC/EPSRC Synthetic Biology Research Centre [BB/L01386X/1]
- NHS Blood and Transplant [WP15-05]
- NIHR Blood and Transplant Research Unit in Red Cell Products [IS-BTU-1214-10032]
- Wellcome [217065/Z/19/Z]
- Wellcome Trust [217509/Z/19/Z, 221708/Z/20/Z] Funding Source: Wellcome Trust
- European Research Council (ERC) [834631, 963992] Funding Source: European Research Council (ERC)
Low-volume antibody assays can be used to track SARS-CoV-2 infection rates in settings with limited active testing. The study developed and evaluated multiple antibody detection methods, demonstrating that low-volume in-house assays provide good diagnostic performance and better sensitivity than a commercial assay.
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.
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