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 |
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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. |
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ISSN: | 1201-9712 1878-3511 |
DOI: | 10.1016/j.ijid.2020.12.017 |