Performance of the SureScreen Diagnostics COVID-19 antibody rapid test in comparison with three automated immunoassays

ElsevierVolume 105, Issue 4, April 2023, 115900Diagnostic Microbiology and Infectious DiseaseAuthor links open overlay panelHighlights•

The SureScreen lateral flow immunoassays (LFIA) showed good clinical performance in comparison with 3 widely used severe acute respiratory syndrome coronavirus 2 antibody assays.

Performance of the SureScreen LFIA was not affected by Alpha, Beta, or Delta variants over a wide range of antibody titers.

The SureScreen LFIA is a good test for detecting previously infected people and for epidemiological studies.

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

SureScreen Diagnostics

Lateral Flow Immunoassays (LFIA)

COVID-19

SARS-CoV-2

serology

AbbreviationsELISA

enzyme-linked immunosorbent assay

LFIA

Lateral Flow Immunoassays

RBD

receptor-binding domain

View Abstract

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