1. Validation and clinical evaluation of a SARS-CoV-2 surrogate virus neutralisation test (sVNT)
- Author
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Nicolas Vuilleumier, Marieke Hoogerwerf, Sabine Yerly, Giulia Torriani, Fion Brouwer, Isabella Eckerle, Benjamin Meyer, Chantal Reusken, Johan Reimerink, Gert Jan Godeke, and Laurent Kaiser
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0301 basic medicine ,Male ,Epidemiology ,Betacoronavirus/genetics/immunology ,ddc:616.07 ,Antibodies, Viral ,Viral/blood ,Neutralization ,Drug Discovery ,Medicine ,Viral/blood/virology ,neutralising antibodies ,ddc:616 ,biology ,General Medicine ,Middle Aged ,Vaccination ,pseudovirus neutralisation assay ,Titer ,Infectious Diseases ,surrogate virus neutralisation assay ,Female ,Antibody ,Coronavirus Infections ,Research Article ,Adult ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,030106 microbiology ,Pneumonia, Viral ,Immunology ,Context (language use) ,Enzyme-Linked Immunosorbent Assay ,Microbiology ,Virus ,Antibodies ,Neutralizing/blood ,cell-based virus neutralisation assay ,03 medical and health sciences ,Betacoronavirus ,Immunity ,Neutralization Tests ,Virology ,Coronavirus Infections/blood/virology ,Humans ,Pandemics ,Aged ,Neutralization Tests/methods ,business.industry ,Enzyme-Linked Immunosorbent Assay/methods ,SARS-CoV-2 ,COVID-19 ,Pneumonia ,Antibodies, Neutralizing ,030104 developmental biology ,biology.protein ,Parasitology ,business - Abstract
To understand SARS-CoV-2 immunity after natural infection or vaccination, functional assays such as virus neutralising assays are needed. So far, assays to detect SARS-CoV-2 neutralising antibodies rely on cell-culture based infection assays either using wild type SARS-CoV-2 or pseudotyped viruses. Such assays are labour-intensive, require appropriate biosafety facilities and are difficult to standardize. Recently, a new surrogate virus neutralisation test (sVNT) was described that uses the principle of an ELISA to measure the neutralisation capacity of anti-SARS-CoV-2 antibodies directed against the receptor binding domain. Here, we performed an independent evaluation of the robustness, specificity and sensitivity on an extensive panel of sera from 269 PCR-confirmed COVID-19 cases and 259 unmatched samples collected before 2020 and compared it to cell-based neutralisation assays. We found a high specificity of 99.2 (95%CI: 96.9–99.9) and overall sensitivity of 80.3 (95%CI: 74.9–84.8) for the sVNT. Clinical sensitivity increased between early (14 dpos/dpd) from 75.0 (64.7–83.2) to 83.1 (76.5–88.1). Also, higher severity was associated with an increase in clinical sensitivity. Upon comparison with cell-based neutralisation assays we determined an analytical sensitivity of 74.3 (56.4–86.9) and 98.2 (89.4–99.9) for titres ≥10 to
- Published
- 2020
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