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Scientific article
Open access
English

Validation and clinical evaluation of a SARS-CoV-2 surrogate virus neutralisation test (sVNT)

Published inEmerging Microbes & Infections, vol. 9, no. 1, p. 2394-2403
Publication date2020
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 days post symptom onset or post diagnosis, dpos/dpd) and late sera (>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 <40 and ≥40 to <160, respectively. Only samples with a titre ≥160 were always positive in the sVNT. In conclusion, the sVNT can be used as an additional assay to determine the immune status of COVID-19 infected of vaccinated individuals but its value needs to be assessed for each specific context.

Keywords
  • Adult
  • Aged
  • Antibodies
  • Neutralizing/blood
  • Antibodies
  • Viral/blood
  • Betacoronavirus/genetics/immunology
  • Coronavirus Infections/blood/virology
  • Enzyme-Linked Immunosorbent Assay/methods
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neutralization Tests/methods
  • Pandemics
  • Pneumonia
  • Viral/blood/virology
Citation (ISO format)
MEYER, Benjamin et al. Validation and clinical evaluation of a SARS-CoV-2 surrogate virus neutralisation test (sVNT). In: Emerging Microbes & Infections, 2020, vol. 9, n° 1, p. 2394–2403. doi: 10.1080/22221751.2020.1835448
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Article (Published version)
Identifiers
ISSN of the journal2222-1751
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Technical informations

Creation12/11/2020 6:02:00 PM
First validation12/11/2020 6:02:00 PM
Update time03/15/2023 11:43:37 PM
Status update03/15/2023 11:43:37 PM
Last indexation02/12/2024 12:00:00 PM
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