Comparison of six commercially available SARS-CoV-2 antibody assays—Choice of assay depends on intended use

•Lateral flow tests with low sensitivity are unsuited to diagnose and monitor SARS-CoV-2.•Sensitive anti-SARS-CoV-2 ELISAs are suitable for COVID-19 diagnosis in mild cases.•IgG ELISA assays with high specificity would be appropriate for seroprevalence studies. Evaluate six commercial serological as...

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Veröffentlicht in:International journal of infectious diseases 2021-02, Vol.103, p.381-388
Hauptverfasser: Nilsson, Anna Christine, Holm, Dorte Kinggaard, Justesen, Ulrik Stenz, Gorm-Jensen, Thøger, Andersen, Nanna Skaarup, Øvrehus, Anne, Johansen, Isik Somuncu, Michelsen, Jens, Sprogøe, Ulrik, Lillevang, Søren Thue
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Sprache:eng
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Zusammenfassung:•Lateral flow tests with low sensitivity are unsuited to diagnose and monitor SARS-CoV-2.•Sensitive anti-SARS-CoV-2 ELISAs are suitable for COVID-19 diagnosis in mild cases.•IgG ELISA assays with high specificity would be appropriate for seroprevalence studies. Evaluate six commercial serological assays for detection of IgA, IgM or IgG SARS-CoV-2 antibodies in different disease severities. Three lateral flow tests (LFTs) (Acro IgM/IgG, CTK IgM/IgG, Livzon IgM/IgG) and three ELISA assays (Euroimmun IgA and IgG, Wantai IgM) were included. Application was evaluated using samples from 57 patients with a positive SARS-CoV-2 reverse transcription polymerase chain reaction, stratified according to disease severity. Specificity was assessed using historical samples from 200 blood donors. While IgM LFTs failed to detect SARS-CoV-2 antibodies in 37–84% of non-hospitalised patients, the Wantai IgM ELISA detected antibodies in 79%. The Euroimmun IgG ELISA detected antibodies in 95% of non-hospitalised patients. IgA, IgM and IgG ELISA levels were initially low, increased over time, and correlated with disease severity. LFT sensitivity declined in samples taken >28 days after symptom onset/resolution. The Livzon IgG LFT had the highest specificity (98.5%), followed by the Euroimmun IgG ELISA (96.2%). The specificity for Euroimmun IgA ELISA improved (≥97.5%) using a custom cut-off value (4.0). The sensitive and semi-quantitative ELISA assays are most appropriate for serologic detection of SARS-CoV-2 infection in mild cases. Livzon LFT and Euroimmun ELISA had the highest specificity among the IgG assays, making them most suitable for seroprevalence studies.
ISSN:1201-9712
1878-3511
DOI:10.1016/j.ijid.2020.12.017