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

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
PMID: 33043818
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Article (Published version) (1.5 MB) - public document Free access
Research groups Chimie et protéomique clinique (270)
Emerging viruses (993)
Groupe Laurent Kaiser (virologie clinique) (668)
(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 https://archive-ouverte.unige.ch/unige:146545

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Deposited on : 2020-12-16

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