Diagn Microbiol Infect Dis . Performance of the SureScreen Diagnostics COVID-19 antibody rapid test in comparison with three automated immunoassays

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Diagn Microbiol Infect Dis


. 2023 Jan 10;105(4):115900.
doi: 10.1016/j.diagmicrobio.2023.115900. Online ahead of print.
Performance of the SureScreen Diagnostics COVID-19 antibody rapid test in comparison with three automated immunoassays


Sarah Mafi ¹ , Sylvie Rogez ² , Jérôme Darreye ² , Sophie Alain ³ , Sébastien Hantz ⁴



Affiliations

• PMID: 36716586
• DOI: 10.1016/j.diagmicrobio.2023.115900

Abstract

Lateral flow immunoassays (LFIA) for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies are used for population surveillance and potentially individual risk assessment. The performance of the SureScreen Diagnostics LFIA targeting the spike protein was evaluated in comparison with 3 automated assays (Abbott Alinity-i SARS-CoV-2 IgG, DiaSorin Liaison® SARS-CoV-2 S1/S2 IgG, Wantai SARS-CoV-2 Ab ELISA). We assessed sensitivity using 110 serum samples from PCR confirmed COVID-19 infected patients. Specificity was evaluated using 120 prepandemic samples, including potential cross-reactive antibodies samples. Sensitivity ranged between 93.3% and 98.7% on samples collected >14 days postsymptom onset. All assays achieved a specificity >98%. Moreover, its performance seems not to be affected by Alpha, Beta or Delta variants over a wide range of antibody titers. The latter showed a very good agreement with the Wantai and the Abbott assays and a substantial agreement with the DiaSorin assay. Our data demonstrate the good clinical performance of the SureScreen Diagnostics LFIA for SARS-CoV-2 seroprevalence screening.

Keywords: COVID-19; Lateral Flow Immunoassays (LFIA); SARS-CoV-2; SureScreen Diagnostics; serology.