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Title

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

Authors
Reimerink, Johan
Brouwer, Fion
Godeke, Gert-Jan
Hoogerwerf, Marieke
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Published in Emerging Microbes & Infections. 2020, vol. 9, no. 1, p. 2394-2403
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 AdultAgedAntibodiesNeutralizing/bloodAntibodiesViral/bloodBetacoronavirus/genetics/immunologyCoronavirus Infections/blood/virologyEnzyme-Linked Immunosorbent Assay/methodsFemaleHumansMaleMiddle AgedNeutralization Tests/methodsPandemicsPneumoniaViral/blood/virology
Identifiers
PMID: 33043818
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Article (Published version) (1.5 MB) - public document Free access
Structures
Research groups Groupe Laurent Kaiser (virologie clinique) (668)
Emerging viruses (993)
Chimie et protéomique clinique (270)
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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 https://archive-ouverte.unige.ch/unige:146545

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Deposited on : 2020-12-16

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